Final 2009 Treatment Technical Report1

International Guideline

Pressure Ulcer Treatment Technical Report

©National Pressure Ulcer Advisory Panel & European Pressure Ulcer Advisory Panel

2009

Treatment Technical Report

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Table of Contents

Foreword. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Suggest Citation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 Limitations and Appropriate Use of This Guideline . . . . . . . .. . . . . . . . . . . 3 Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Guideline Developers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Executive Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Methodology for Guideline Development. . . . . . . . . . . . . . . . . . . . . . . . .. 20 International NPUAP-EPUAP Pressure Ulcer Classification System . . . . 29

Pressure Ulcer Treatment Tables Classification of Pressure Ulcers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Assessment and Monitoring of Healing . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Role of Nutrition in Pressure Ulcer Healing . . . . . . . . . . . . . . . . . . . . . . . 50 Pain Assessment and Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Support Surfaces for Treatment of Pressure Ulcers . . . . . . . . . . . . . . . . . 74 Cleansing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79 Debridement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83 Dressings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99 Assessment and Treatment of Infection . . . . . . . . . . . . . . . . . . . . . . . . ..117 Biophysical Agents in Pressure Ulcer Management . . . . . . . . . . . . . . . . 124 Growth Factors for Pressure Ulcer Treatment . . . . . . . . . . . . . . . . . . . . 134 Surgery for Pressure Ulcers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .140 Pressure Ulcer Management in Individuals Receiving Palliative Care . 160


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Foreword The International Pressure Ulcer Guideline summarizes recommendations and

supporting evidence for pressure ulcer prevention and treatment. It was

developed as a 4-year collaborative effort between the European Pressure

Ulcer Advisory Panel (EPUAP) and American National Pressure Ulcer Advisory

Panel (NPUAP). It provides a detailed analysis and discussion of available

research, critical evaluations of the assumptions and knowledge of the field, a

description of the methodology used to develop the guideline, and the

acknowledgments of editors, authors, and other contributors.

The Clinical Practice Guideline is intended for professionals interested in both

the recommendations for pressure ulcer care and the scientific evidence

supporting those recommendations. A Quick Reference Guide version is also

available that contains excerpts from the Clinical Practice Guideline. The Quick

Reference Guide version is intended for busy clinicians who need a “quick”

reference in caring for individuals with pressure ulcers and/or who are at risk

for developing pressure ulcers. Users should not rely on these excerpts alone.

This Pressure Ulcer Treatment Technical Report includes the evidence tables

used as a basis for guideline development. It is intended for researchers,

educators and clinicians who wish to more fully explore the research

supporting the treatment recommendations and evidence summaries

presented in the Clinical Practice Guideline.

Printed copies of the English editions of the Clinical Practice Guideline and

Quick Reference Guide are available through the NPUAP website

(www.npuap.org). The Quick Reference Guide has been translated into several

languages; translations are available on the EPUAP website (www.epuap.org).

The Prevention Technical Report and Treatment Technical Report are only

available in electronic version from NPUAP (www.npuap.org) and EPUAP.

The goal of this international collaboration was to develop evidence-based

recommendations for the prevention and treatment of pressure ulcers that

could be used by health care professionals throughout the world. An explicit

scientific methodology was used to identify and evaluate available research.

In the absence of definitive evidence, expert opinion (often supported by

indirect evidence and other guidelines) was used to make recommendations.

http://www.epuap.org/

http://www.npuap.org/


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Guideline recommendations were made available to 903 individuals and 146

societies/organizations registered as stakeholders in 63 countries on 6

continents. The final guideline is based on the available research and the

accumulated wisdom of the EPUAP, NPUAP, and international stakeholders.

Suggested Citation The EPUAP and NPUAP welcome the use and adaptation of this guideline at a

national and local level. However, we request citation as to the source, using

the following format:

National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory

Panel. Pressure Ulcer Treatment: Technical Report. Washington DC: National

Pressure Ulcer Advisory Panel; 2009. Available at www.npuap.org.

Limitations and Appropriate Use of This Guideline • Guidelines are systematically developed statements to assist practitioner

and patient decisions about appropriate health care for specific clinical

conditions. The recommendations may not be appropriate for use in all

circumstances.

• The decision to adopt any particular recommendation must be made by the

health care professional in light of available resources and circumstances

presented by the individual patient. Nothing contained in this guideline is to

be considered medical advice for specific cases.

• Because of the rigorous methodology used to develop this guideline, the

NPUAP and EPUAP believe that the research supporting these

recommendations is reliable and accurate. However, we do not guarantee the

reliability and accuracy of individual studies referenced in this document.

• This guideline and any recommendations herein are intended for

educational and informational purposes only.

• This guideline contains information that was accurate at the time of

publication. Research and technology change rapidly and the

recommendations contained in this guideline may be inconsistent with future

advances. The health care professional is responsible for maintaining a

working knowledge of the research and technological advances that may

affect his/her practice decisions.

• Generic names of products are provided. Nothing in this guideline is

intended as an endorsement of a specific product.

http://www.npuap.org/


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• Nothing in this guideline is intended as advice regarding coding standards or

reimbursement regulations.

Abstract This guideline is the result of a collaborative effort between the American

National Pressure Ulcer Advisory Panel (NPUAP) and European Pressure Ulcer

Advisory Panel (EPUAP). A comprehensive literature review was conducted on

pressure ulcer prevention and treatment. A rigorous scientific methodology

was used to analyze available research and to make evidence-based

recommendations for the prevention and treatment of pressure ulcers. Drafts

of the guideline were made available to 903 individuals and 146

societies/organizations registered as stakeholders in 63 countries on 6

continents. All stakeholder comments were carefully considered by guideline

developers. Explicit recommendations and summaries of supporting evidence

are provided for the following aspects of pressure ulcer prevention: etiology,

risk assessment, skin assessment, nutrition, repositioning, support surfaces,

and special pressure ulcer preventive needs of patients in the operating room.

Recommendations and research were also summarized for a wide variety of

topics related to pressure ulcer treatment: classification of pressure ulcers,

assessment and monitoring of healing, the role of nutrition in healing, pain

assessment and management, support surfaces, principles of wound bed

preparation (i.e., cleansing, debridement, dressing selection, assessment and

treatment of infection), biophysical agents (e.g., electrical stimulation,

negative pressure wound therapy), surgery, and management in individuals

receiving palliative care. The NPUAP and EPUAP also agreed on an

international classification system for pressure ulcers with the hope that it

will be adopted internationally and therefore help reduce discrepancies in

international reporting of pressure ulcer incidence and prevalence.


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Guideline Development Group

EPUAP Carol Dealey, PhD, RN (EPUAP Chair)

Research Development Team,

University Hospital Birmingham, NHS Foundation Trust,

Birmingham, United Kingdom

Michael Clark, PhD

Wound Healing Research Unit, Cardiff University,

Cardiff, United Kingdom

Tom Defloor, PhD, RN

Nursing Science, Ghent University, Ghent, Belgium

Lisette Schoonhoven, PhD, RN

Nursing Science, St Radboud University,

Nijmegen, The Netherlands

Katrien Vanderwee, PhD, RN

Nursing Science, Ghent University, Ghent, Belgium

Anne Witherow, RN

Associate Director of Nursing, Western Health and Social

Care Trust, Northern Ireland

NPUAP Janet Cuddigan, PhD, RN CWCN

(NPUAP Co-Chair & Editor-in-Chief)

University of Nebraska Medical Center, Omaha, NE, USA

Diane K. Langemo, PhD, RN, FAAN

(NPUAP Co-Chair)

University of North Dakota, Grand Forks, ND, USA

Mona M. Baharestani, PhD, ANP, CWON, CWS

East Tennessee State University, Johnson City, TN, USA

James H. Quillen

Veterans Affairs Medical Center, Johnson City, TN, USA


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Joyce Black, PhD, RN, CWCN, CPSN

University of Nebraska Medical Center, Omaha, NE, USA

Evan Call, MS

Weber State University, Centerville, UT, USA

Mary Ellen Posthauer, RD, CD, LD

Supreme Care West, LLC, Evansville, IN, USA

Consultants Steven Black, MD, FACS served as a medical consultant to the Guideline Development

Group. Dr. Black is a plastic surgeon at The Nebraska Medical Center, Omaha, NE, USA.

Phillip Smith, MD served as a consultant on the assessment and management of

infection. Dr. Smith is a Professor in Internal Medicine and Chief of the Infectious

Diseases Section at the University of Nebraska Medical Center in Omaha, NE, USA. He

is a Fellow of the American College of Physicians and the Infectious Diseases Society of

America.

Small Working Group (SWG) Members Prevention Aetiology: Cees Oomens (Leader), José Verdu Soriano, Dan Bader & Amit Gefen • Risk

Assessment: Jane Nixon (Leader), Jacqui Fletcher, Alexander Heyneman, Helvi

Hietanen, Jeannie Donnely, Khryz Gebhardt, Maureen Benbow, Zena Moore & Katrien

Vanderwee • Skin Assessment: Carol Dealey (Leader), Katrien Vanderwee, Lisette

Schoonhoven, Tom Defloor • Nutrition for Pressure Ulcer Prevention: Jos Schols

(Leader), Ruud Halfens, Pam Jackson, Gero Langer, Judith Meijers & Hilde Heyman •

Repositioning for Prevention of Pressure Ulcers: Zena Moore (Leader), Trudie Young,

Anna Polak & Hilde Heyman • Support Surfaces: Lena Gunningberg (Leader), Andrea

Bellingeri, Paulo Alves, Mark Collier, Katia Furtado, Jan Weststrate & Erik de Laat •

Special Population: Patients in the Operating Room: Lisette Schoonhoven (Leader)

Lena Gunningberg (Leader), Andrea Bellingeri, Paulo Alves, Mark Collier, Katia Furtado,

Jan Weststrate & Erik de Laat

Treatment Classification of Pressure Ulcers: Joyce Black (Leader), Janet Cuddigan, Tom Defloor &

Courtney Lyder • Assessment & Monitoring of Healing: Janet Cuddigan (Leader),

Susan Garber & Diane Langemo • Role of Nutrition in Pressure Ulcer Healing: Mary

Ellen Posthauer (Leader), Becky Dorner, David Thomas & Steven Black • Pain

Assessment & Management: Diane Langemo (Leader) & Barbara Bates-Jensen •

Support Surfaces for Treatment of Pressure Ulcers: Evan Call (Leader), Joyce Black,


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Steven Black, David Brienza, Janet Cuddigan, Kim Davis, Susan Garber, Diane Langemo

& Steven Reger • Wound Bed Preparation & Biofilms: Greg Schultz • Cleansing:

Catherine Ratliff (Leader), George Rodeheaver & Greg Schultz • Debridement: Mona

Baharestani (Leader), Steven Black & Carrie Sussman • Dressings: Joyce Black (Leader),

Laurie McNichol (Leader) & Karen Zulkowski (Leader), Sharon Baranoski, Barbara

Bates-Jensen & Joann Maklebust • Assessment & Treatment of Infection: Catherine

Ratliff (Leader), Joyce Black, Janet Cuddigan, George Rodeheaver & Greg Schultz •

Biophysical Agents in Pressure Ulcer Management: Teresa Conner-Kerr (Leader),

Carrie Sussman, Luther Kloth, Laura Edsberg & Diane Langemo • Negative Pressure

Wound Therapy: Joyce Black & Laurie McNichol • Biological Dressings & Growth

Factors: Laura Edsberg (Leader), Harold Brem, Aimee` Garcia & Greg Schultz • Surgery

for Pressure Ulcers: Steven Black (Leader), Joyce Black & Harold Brem • Pressure Ulcer

Management in Individuals Receiving Palliative Care: Diane Langemo (Leader) &

Barbara Bates-Jensen, with assistance from Steven Antokal & Nicole Hayes

Acknowledgments

The European Pressure Ulcer Advisory Panel (EPUAP) and National Pressure

Ulcer Advisory Panel (NPUAP) gratefully acknowledge the contributions of the

following individuals and groups for financially supporting the presentation

and dissemination of the guideline. All financial contributions were made

after the guideline was developed and in no way influenced the development

of the guideline or its content. Financial contributions are being used for the

printing and dissemination of the guideline. The following companies

provided unrestricted education grants:

NPUAP Donors

Platinum Level Contributor ($20,000 or greater)

Kinetic Concepts, Inc

Gold Level Contributor ($10,000 to $19,999)

American Medical Technologies, Inc

Silver Level Contributors ($1,000 to $9,999)

Coloplast

EHOB, Incorporated

Genesis HealthCare

HCR ManorCare


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Nestlé Nutrition

Smith & Nephew

Bronze Level Contributor ($1,000 or less)

SAM Medical Products

EPUAP Donors

ArjoHuntleigh, Europe

Hill-Rom, Europe

Nutricia Advanced Medical Nutrition

Kinetic Concepts, Inc

In Kind Contributions

McGoogan Library, University of Nebraska Medical Center, Omaha,

NE, USA (database searches by a professional librarian & interlibrary

loan services)

College of Nursing, University of Nebraska Medical Center, Omaha,

NE, USA

World Union of Wound Healing Societies and the University of

Toronto, Toronto, CA (initial database searches)

The Registered Nurses of Ontario, Royal College of Nursing,

Consortium on Spinal Cord Injury Medicine, Agency for Health Care

Policy and Research (now AHRQ) provided evidence tables used to

support previous guidelines.

Eran Ganz-Lindgren reviewed an article written in Hebrew.

Stakeholders

Special thanks go to the many stakeholders across the globe who reviewed

guideline processes and drafts. All stakeholder comments were reviewed by

the EPUAP-NPUAP Guideline Development Group. Revisions were made

based on these comments. We appreciate the investment of clinicians,

researchers, educators, and manufacturers from all over the world who took

the time to share their expertise and thoughtful critique. The guideline

recommendations are better because of you!

Special thanks go to Timothy J. Gilbert, BA his excellent work in preparing this

document and supporting the work of the Guideline Development Group.


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Executive Summary

Significance Pressure ulcers are painful, costly, and often preventable complications that

threaten many individuals in hospitals, nursing homes, and home care. They

remain a frequently occurring health care problem throughout the world. A

European pilot survey undertaken by the European Pressure Ulcer Advisory

Panel (EPUAP), which included 5947 patients located in Belgium, Italy,

Portugal, Sweden, and the United Kingdom, found an overall prevalence of

18.1%, although there was some variation between countries (1). In 2001, The

National Pressure Ulcer Advisory Panel (NPUAP) estimated that pressure ulcer

prevalence in American hospitals was 15% and the incidence 7% (2).

More recent national studies fail to demonstrate sustained significant

declines in American hospitals or other health care settings (3, 4). Prevalence

and incidence rates are often higher in unique populations such as those

receiving palliative care in home hospice (5, 6), those with spinal cord injuries

(7), and in critical care units (8). Pressure ulcers represent a major burden of

sickness and reduced quality of life for patients and their carers (9–11).

Increased morbidity and mortality associated with pressure ulcer

development in hospitalized patients is documented in multiple studies (12–

15). Hospital lengths of stay, readmission rates, and hospital charges are

greater in patients who develop pressure ulcers than in those remaining

ulcer-free (12–14, 16). The development of a single pressure ulcer in U.S.

hospitals can increase a patient’s length of stay five-fold and increase hospital

charges by $2,000–11,000 (12). Recent European cost-models to highlight the

cost of illness associated with pressure ulcers have indicated that the total

costs may consume between 1% in the Netherlands (17) and 4% in the United

Kingdom (18) of health care expenditure.

Purpose and Scope The goal of this guideline is to provide evidence-based recommendations for

the prevention and treatment of pressure ulcers that can be used by health

care professionals throughout the world. The purpose of the prevention

recommendations is to guide evidence-based care to prevent the

development of pressure ulcers. The prevention recommendations will apply


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to all vulnerable individuals of all age groups. The guideline is intended for the

use of health care professionals who are involved in the care of patients and

vulnerable people who are at risk of developing pressure ulcers, whether they

are in a hospital, long-term care, assisted living at home, or any other setting,

and regardless of their diagnosis or other health care needs. It will also help

to guide patients and carers on the range of prevention strategies that are

available.

The purpose of the treatment recommendations is to guide evidence-based

care for patients with existing pressure ulcers. The treatment

recommendations apply to all individuals with pressure ulcers regardless of

setting. The guideline is intended for the use of health care professionals who

are involved in the care of patients with existing pressure ulcers. It will also

guide patients and caregivers. Patients with pressure ulcers are usually at risk

for additional pressure ulcers, therefore the prevention guideline should also

be followed for these individuals.

Guideline Development The European Pressure Ulcer Advisory Panel (EPUAP) and the American

National Pressure Ulcer Advisory Panel (NPUAP) collaborated to develop

guidelines on the prevention and treatment of pressure ulcers. The EPUAP

took the lead on the pressure ulcer prevention guideline in collaboration with

the NPUAP, and the NPUAP took the lead on the pressure ulcer treatment

guideline in collaboration with the EPUAP. The guidelines were produced by a

multidisciplinary Guideline Development Group (GDG) and several Small

Working Groups (SWGs) consisting of members of both EPUAP and NPUAP.

The GDG determined and monitored the guideline development process. The

entire process of developing the guideline could be followed by stakeholders

on a website (www.pressureulcerguideline.org).

The first step in the guideline development process was identifying the

evidence. The GDG conducted an extensive review of the literature on

pressure ulcer prevention and treatment in several electronic databases using

a sensitive search strategy. All retrieved references were screened by the

GDG on predetermined inclusion criteria. In a second step, the retrieved

evidence was evaluated, and thereafter the full papers were divided

according to topic and sent to the relevant SWGs. The members of the SWGs

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created evidence tables and scored a methodology checklist developed by the

GDG for each study. The level of evidence was noted for each study, using a

classification system adapted from Sackett (19).

The next step was drafting the recommendations. Each SWG formulated

conclusions about the body of available evidence based on the evidence

tables and quality evaluations. In step 4, strength of evidence ratings were

then assigned to recommendations. This rating identifies the strength of

cumulative evidence supporting a recommendation. In the final step, the

SWGs summarized the evidence supporting each statement.

Guideline Recommendations Guidelines are systematically developed statements to assist practitioner

and patient decisions about appropriate health care for specific clinical

conditions. The recommendations may not be appropriate for use in all

circumstances. The decisions to adopt any particular recommendation must

be made by the health care professional in light of available resources and

the circumstances presented by the individual patient. Nothing contained

in this book is to be considered medical advice for specific cases. This book

and any recommendations herein are intended for educational and

informational purposes only. Generic names of products are provided.

Nothing in this guideline is intended as an endorsement of a specific

product.

Prevention The prevention guideline comprises seven topics: etiology, risk assessment,

skin assessment, nutrition, positioning, support surfaces, and special

populations: operating room patients.

Etiology

The etiology section is an introductory section to the prevention guideline.

The procedure for the development of this section was different from that

for the other guideline sections. As etiology research is more basic science,

only a few studies were retrieved with the literature search strategy.

Therefore, this section started from the current state of the art and

knowledge on etiology and gives a brief overview consisting of four items:

mechanical load/magnitude and time, tissue reactions at different types of


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mechanical loading, mechanisms that lead to tissue damage and factors

that influence susceptibility.

Risk Assessment

Risk assessment is a central component of clinical practice that aims to

identify susceptible patients in order to target appropriate interventions to

prevent pressure ulcer occurrence. The statements on risk assessment

include risk assessment policy and risk assessment practice. Using a

structured approach to risk assessment to identify vulnerable patients is of

primary importance and includes the use of a risk assessment scale in

combination with a comprehensive skin assessment, the assessment of

activity and mobility and clinical judgment. In this guideline, most

frequently occurring risk factors are described. The main risk factors are

nutritional indicators, factors affecting perfusion and oxygenation, skin

moisture, and increased age. The statements on risk factors were based on

studies using multivariable analysis. However, one must be careful with

interpreting the results of these epidemiological research studies as the

results may depend on which risk factors are included in the multivariable

model.

Risk assessment should be conducted on admission, and repeated as

frequently as required by patient acuity. Reassessment should also be

undertaken if there is any change in patient condition.

Skin Assessment

Skin assessment is important in pressure ulcer prevention because skin

status has been identified as a risk factor for pressure ulcer development.

The skin can also serve as an indicator of early signs of pressure damage.

This section comprises statements on skin assessment and skin care. A

complete skin assessment consisting of assessment for localized heat,

edema, or induration (hardness) should be included in the risk assessment

screening policy. Skin care comprises statements on how to protect the

skin from pressure ulcer development by, for example, not using massage,

not turning the individual onto a body surface still reddened from a previous

episode of pressure loading, and not vigorously rubbing skin at risk for

pressure ulceration.


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Nutrition

Multivariate analysis of epidemiological data indicates that a poor nutritional

status and related factors, such as low body weight and poor oral food intake

are independent risk factors for the development of pressure ulcers. However,

the exact causal relationship between a pressure ulcer and nutrition still

remains unclear.

In this guideline, malnutrition refers to a status of under-nutrition. This

section starts with general recommendations based on the ESPEN (The

European Society for Clinical Nutrition and Metabolism) and the ASPEN

(The American Society for Parenteral and Enteral Nutrition) guidelines and

on literature specific to nutrition, including recommendations on

nutritional screening and assessment.

Specific studies on nutritional interventions to prevent pressure ulcers are

scarce. It is recommended to offer high-protein mixed oral nutritional

supplements and/or tube feeding in addition to the usual diet to individuals

with nutritional risk and pressure ulcer risk because of acute or chronic

diseases or following a surgical intervention.

Repositioning

Repositioning involves a change in position in the lying or seated individual,

with the purpose of relieving or redistributing pressure and enhancing

comfort, undertaken at regular intervals. Repositioning should be

considered in all at-risk individuals and must take into consideration the

condition of the patient and the support surface in use.

The repositioning frequency should be influenced by the individual and the

support surface in use. Repositioning should maintain the individual’s

comfort, dignity, and functional ability. In addition, statements on

repositioning the seated individual, on repositioning documentation, and on

repositioning education and training are provided.

Support Surfaces

Support surfaces are specialized devices for pressure redistribution,

designed for management of tissue loads, microclimate, and/or other

therapeutic functions (e.g., any mattress, integrated bed system, mattress

replacement, mattress overlay, seat cushion, or seat cushion overlay). This


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section starts with some general statements on support surfaces for the

prevention of pressure ulcers.

The recommendations consist of four detailed items: mattress and bed

use, the prevention of heel pressure ulcers, seats and cushions, and other

forms of support surface.

• Mattress and bed use in pressure ulcer prevention. It is

recommended to use a higher specification foam mattress rather

than non-pressure redistributing mattress for all individuals

assessed as at-risk for pressure ulcer development. There is no

evidence of the superiority of one high specification foam mattress

over alternative high specification foam mattresses. Use an active

support surface (overlay or mattress) for patients at higher risk of

pressure ulcer development where frequent manual repositioning

is not possible. Overlay and mattress-replacement alternating-

pressure active-support surfaces have a similar efficacy in terms of

pressure ulcer incidence. Do not use small-cell alternating-

pressure air mattresses or overlays. Continue to turn and

reposition where possible all individuals at risk of pressure ulcers.

• When using support surfaces to prevent heel pressure ulcers,

ensure that heels are free of the surface of the bed. Heel

protecting devices should elevate the heel completely (off load) in

such a way as to distribute the weight of the leg along the calf

without putting pressure on the Achilles tendon. The knee should be

in slight flexion.

• The section on the use of support surfaces to prevent pressure

ulcers while seated includes statements on the use of a pressure

redistribution seat cushion.

• The recommendations relating to other support surfaces in

pressure ulcer prevention include statements on the use of

sheepskins.

Special Populations: Patients in the Operating Room

As pressure ulcers frequently occur in patients on surgical units or wards,

particular attention should be paid to patients undergoing surgery. This

section includes statements on refining risk assessment of individuals

undergoing surgery, using pressure-redistributing mattresses on the


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operating table, positioning of the patient, and paying attention to pressure

redistribution prior to and after surgery.

Treatment Recommendations and research were also summarized for a

comprehensive array of topics related to pressure ulcer treatment.

Pressure Ulcer Classification

Pressure ulcer treatment begins with an accurate diagnosis and classification

of pressure ulcers. A validated pressure ulcer classification system should be

used. Professionals should be educated about the appearance of different

types of tissue, differentiating pressure ulcers from other types of wounds

and skin conditions, and special techniques for assessing darkly pigmented

skin. Inter-rater reliability should be confirmed. Pressure ulcers on mucous

membranes should not be classified using existing classification systems.

Assessment and Monitoring of Healing

An initial holistic assessment should be performed on all patients with

pressure ulcers. Reassess the patient and treatment plan if the ulcer fails to

show signs of healing within two weeks. The pressure ulcer should be

assessed at least weekly; specific strategies for assessment are provided.

Simple documentation of pressure ulcer status is not enough. The

professional should continuously monitor progress toward healing,

adjusting treatment plans as needed. Two tools for monitoring pressure

ulcer healing are recommended.

Role of Nutrition in Pressure Ulcer Healing

Nutritional status should be assessed for all individuals with pressure ulcers

initially, with a change in condition, and when the ulcer is not showing signs

of healing. Specific recommendations are provided to address the caloric,

protein, fluid, vitamin, and mineral intake necessary to support healing.

Pain Assessment and Management

Pressure ulcer-related pain is a common complication that is often under-

treated. Pain should be evaluated in all patients with pressure ulcers,

including infants, children, and cognitively impaired adults. Specific

recommendations are provided for preventing pain, managing general pain,

reducing debridement pain, and managing chronic pain.


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Support Surfaces for Treatment of Pressure Ulcers

Support surfaces and repositioning strategies are part of a total program

of pressure ulcer prevention and treatment. Support surfaces facilitate

pressure redistribution through immersion, envelopment, and/or by

shifting the contact area from one part of the individual’s body to another.

There is also a growing appreciation of the role of microclimate control in

supporting pressure ulcer healing. While professionals caring for an

individual with pressure ulcers may desire clear-cut protocols on support

surface selection, the strength of current evidence does not support

prescriptive recommendations. Available evidence on the effects of various

support surfaces on pressure ulcer healing is presented. This evidence

should be used to help make clinical decisions that best match the needs

of the patient with the characteristics of the support surface. The special

needs of critically ill, spinal cord injured, and bariatric patients are

addressed.

Wound Bed Preparation: Cleansing, Debridement & Dressings

Overarching principles of wound bed preparation and the special

challenges posed by biofilms are presented. Recommendations and

research evidence are provided for the critical approaches necessary to

prepare the wound bed for healing: cleansing, debridement, and selection of

dressings. Saline or potable water may be used to cleanse most pressure

ulcers; solutions with surfactants and/or antimicrobials may be used for

pressure ulcers with debris or suspected/confirmed infection. Cleansing the

peri-wound has been shown to decreases bacterial counts in the wound.

Debridement methods, indications, and contraindications are discussed in

relation to available evidence.

Over the past decade, there has been substantial research and

development in the area of dressings. Recommendations and supporting

evidence are provided for the use of myriad dressings, including

hydrocolloid, transparent film, hydrogel, alginate, foam, polymeric

membrane, silver-impregnated, honey-impregnated, cadexomer iodine-

impregnated, gauze, silicone-coated, collagen matrix, and composite

dressings for the treatment of pressure ulcers.


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Assessment and Treatment of Infection

Infected pressure ulcers do not heal. Prevention, early diagnosis, and

effective treatment of infection are critical components of pressure ulcer

healing. Recommendations focus on early identification of patients at high

risk for pressure ulcer infection and early recognition of critical colonization

and local infection using more subtle clinical indicators, such as new or

increasing ulcer pain, pocketing, friable granulation tissue, and increased

drainage. Quantitative tissue culture is the gold standard for diagnosing

infection; however, the Levine quantitative swab culture technique has

demonstrated reasonable sensitivity and specificity. Management of

pressure ulcer infection focuses on optimizing the host response,

preventing contamination, and reducing the bacterial load. The special

challenges posed by biofilms are discussed. A variety of topical

antimicrobial agents (including properly selected and diluted antiseptics,

silver, medical-grade honey, and cadexomer iodine) are receiving cautious

consideration in an era of growing antibiotic resistance. Systemic antibiotics

are usually reserved for systemic infections, such as cellulitis, fasciitis,

osteomyelitis, bacteremia, and sepsis.

Biophysical Agents in Pressure Ulcer Management

Different forms of energy (e.g., mechanical, electrical, magnetic, light) have

been used in the management of pressure ulcers. Properly designed and

conducted studies of pressure ulcer healing in human subjects provide

sufficient evidence to recommend electrical stimulation, and negative

pressure wound therapy under carefully selected circumstances. Several

additional modalities are considered based on indirect evidence and/or

expert opinion. These include pulsed electromagnetic fields, ultraviolet light,

ultrasound, whirlpool, and pulsed lavage with suction. There is currently

insufficient evidence to recommend infrared therapy, laser therapy,

hyperbaric oxygen therapy, and topical oxygen therapy as biophysical agents

for pressure ulcer treatment. There was also insufficient evidence to support

the use of biological dressings and growth factors, although these treatments

have been effective in diabetic (neurotrophic) foot ulcers.

Surgery for Pressure Ulcers

Current research examining the outcomes of surgical treatments for pressure

ulcers is examined. Rather than focus on a specific surgical technique, the

recommendations in this sections focus on preoperative preparation,


18

intra- operative care, post-operative care, and rehabilitation designed to

support a long-term successful outcome.

Pressure Ulcer Management of Individuals Receiving Palliative Care

All aspects of pressure ulcer care are re-examined through the lens of

patients receiving palliative care. Principles of palliative care and research

on pressure ulcer care are synthesized to provide guidance focused on

respect for the individual’s wishes, maintaining comfort, and optimizing

quality of life. Specific recommendations address repositioning, pain

management, and exudate-odor control.

References (1) Vanderwee K, Clark M, Dealey C, Gunningberg L, Defloor T. Pressure ulcer

prevalence in Europe: a pilot study. J Eval Clin Pract. 2007;13(2):227-32.

(2) National Pressure Ulcer Advisory Panel. Pressure ulcers in America: prevalence,

incidence, and implications for the future. Cuddigan J, Ayello E, Sussman C, editors.

Reston, VA: NPUAP; 2001.

(3) Russo CA, Elixhauser A. Hospitalizations related to pressure sores, 2003.

Healthcare Cost and Utilization Project. Rockville, MD: Agency for Healthcare

Research and Quality; 2007.

(4) VanGilder C, MacFarlane GD, Meyer S. Results of nine international pressure

ulcer prevalence surveys: 1989 to 2005. Ostomy Wound Manage. 2008;54(2):40-54.

(5) Reifsnyder J, Magee HS. Development of pressure ulcers in patients receiving

home hospice care. Wounds. 2005;17(4):74-9.

(6) Tippett AW. Wounds at the end of life. Wounds. 2005;17(4):91-8.

(7) Cardenas DD, Hoffman JM, Kirshblum S, McKinley W. Etiology and incidence of re-

hospitalization after traumatic spinal cord injury: a multicenter analysis. Arch Phys

Med Rehabil. 2004;85(11):1757-63.

(8) Shahin ESM, Dassen T, Halfens RJG. Pressure ulcer prevalence and incidence

in intensive care patients: a literature review. Nursing In Critical Care.

2008;13(2):71-9.

(9) Franks PJ, Moffatt CJ, Ellison DA, Connolly M, Fielden S, Groarke L, et al. Quality

of life in venous ulceration: A randomized trial of two bandage systems. Phlebology.

1999;14:95-9.

(10) Hopkins A, Dealey C, Bale S, Defloor T, Worboys F. Patient stories of living

with a pressure ulcer. J Adv Nurs.2006;56(4):345-53.

(11) Nixon J, Nelson EA, Cranny G, Iglesias CP, Hawkins K, Cullum NA, et al. Pressure

relieving support surfaces: a randomised evaluation. Health Technol Assess.

2006;10(22):iii-x, 1.


19

(12) Allman RM, Goode PS, Burst N, Bartolucci AA, Thomas DR. Pressure ulcers,

hospital complications, and disease severity: impact on hospital costs and length of

stay. Adv Wound Care. 1999;12(1):22-30.

(13) Allman RM, Laprade CA, Noel LB, Walker JM, Moorer CA, Dear MR, et al.

Pressure sores among hospitalized patients. Ann Intern Med. 1986;105(3):337-42.

(14) Ducker A. Pressure ulcers: assessment, prevention, and compliance. Case

Manager. 2002;13(4):61-4.

(15) Kumar RN, Gupchup GV, Dodd MA, Shah B, Iskedjian M, Einarson TR, et al.

Direct health care costs of 4 common skin ulcers in New Mexico Medicaid fee-for-

service patients. Adv Skin Wound Care. 2004;17(3):143-9.

(16) Stausberg J, Kroger K, Maier I, Schneider H, Niebel W. Pressure ulcers in

secondary care: incidence, prevalence, and relevance. Adv Skin Wound Care.

2005;18(3):140-5.

(17) Severens JL, Habraken JM, Duivenvoorden S, Frederiks CMA. The cost of illness

of pressure ulcers in The Netherlands. Adv Skin Wound Care. 2002;15(2):72-7.

(18) Bennett G, Dealey C, Posnett J. The cost of pressure ulcers in the UK. Age Ageing.

2004;33(3):230-5.

(19) Sackett DL. Evidence-based medicine: how to practice and teach EBM New York,

NY: Churchill Livingstone; 1997.


20

Methodology for Guideline Development

Purpose and Scope The overall purpose of this international collaboration was to develop

evidence-based recommendations for the prevention and treatment of

pressure ulcers that could be used by health care professionals throughout

the world. A joint Guideline Development Group with representatives from

both the NPUAP and the EPUAP planned the guideline development

process and reviewed all the documentation. However, to simplify logistics,

the EPUAP took the lead on the pressure ulcer prevention

recommendations, and the NPUAP took the lead on the pressure ulcer

treatment recommendations.

The purpose of the prevention recommendations is to guide evidence-based

care to prevent the development of pressure ulcers. The prevention

recommendations will apply to all vulnerable individuals of all age groups.

The guideline is intended for the use of health care professionals who are

involved in the care of patients and vulnerable people who are at risk of

developing pressure ulcers, whether they are in a hospital, long-term care,

assisted living at home, or any other setting and regardless of their diagnosis

or health care needs. It will also help to guide patients and carers on the

range of prevention strategies that are available.

The purpose of the treatment recommendations is to guide evidence-based

care for patients with existing pressure ulcers. The treatment

recommendations apply to all individuals with pressure ulcers regardless of

setting. The guideline is intended for the use of health care professionals

who are involved in the care of patients with existing pressure ulcers. It will

also guide patients and caregivers. Patients with pressure ulcers are usually

at risk for additional pressure ulcers; therefore, the prevention guideline

should also be followed for these individuals. Based on the results of a gap

analysis of existing pressure ulcer treatment guidelines, recommendations

regarding the unique needs of several special populations have been

addressed where evidence exists. These include spinal cord injured

individuals, infants and children, critically ill patients, bariatric patients, and

patients requesting palliative care.


21

A rigorous and explicit methodology was agreed upon at the onset of this

collaboration and rigorously adhered to throughout the development of

the guideline. This methodology for evidence-based guideline development

is described below.

Participants

Guideline Development Group. The EPUAP and NPUAP nominated six

representatives each to form the Guideline Development Group (GDG).

The EPUAP and NPUAP each had six votes during joint deliberations, with

the majority deciding. Examination of the evidence and consensus building

preceded all votes. Minority opinions were represented in meeting

minutes.

The GDG determined and monitored the guideline development process. As

an initial step, the GDG reviewed the literature on guideline development

methodologies and internationally developed criteria evaluating the quality of

guidelines. The group agreed upon a methodology that was sufficiently clear

to be reliably and consistently followed by the small working groups of

international experts reviewing the evidence and drafting the

recommendations, yet rigorous in meeting quality standards. This guideline

development methodology is described in detail below.

GDG members and others involved in the actual development of the

guideline were screened for potential conflicts of interest. Representatives of

industry were excluded from developmental groups but were invited to

participate as stakeholders.

Small Working Groups. The guideline content was broken down into topics,

and Small Working Groups (SWGs) were formed to review the evidence

available for each topic. Guideline development was an iterative process,

with GDG and SWG members maintaining close communication. Evidence

summaries and draft recommendations developed by the SWGs were

reviewed by the GDG for (1) comprehensiveness and accuracy of literature

reviews, (2) methodological rigor in evidence analysis and application to

clinical practice, and (3) clarity and appropriateness of recommendations

for an international audience.


22

Stakeholders. The entire process of developing the guideline could be

followed by stakeholders on a website,

(http://www.pressureulcerguideline.org). A stakeholder is someone who has

interest in pressure ulcers and wishes to contribute to the guideline by

reading the methodology, search strategies, references under

consideration, and draft recommendations, ensuring that all relevant

evidence had been included and commenting on the draft guideline within

the timeframe allowed.

A total of 903 individuals and 146 societies/ organizations registered as

stakeholders. Sixty-three countries on six continents were represented in

this group. Anyone could become a stakeholder, either as an individual or as

a representative for a society/organization. All members of the EPUAP and

the NPUAP were encouraged to sign up as stakeholders and participate in

this process. Individuals with a history of pressure ulcers were recruited to

review the guideline from a consumer perspective. When new

recommendations were posted on the website, registered stakeholders

were notified by electronic mail. The GDG reviewed all stakeholder

comments and any additional evidence recommended by stakeholders

before approving final recommendations. Stakeholders identified additional

evidence that was incorporated into the guideline and provided an

international perspective for translating evidence into practice

recommendations.

Methods The steps of the guideline development process are delineated below. For

simplicity and clarity, the process is described as linear and sequential;

however, the actual process was iterative, with multiple drafts developed and

progressively improved based on ongoing communication among GDG

members, SWG members, and stakeholders.

Step 1: Identifying the Evidence

Databases. To identify the scientific literature on pressure ulcer prevention

and treatment, several electronic databases were consulted, such as

PubMed, CINAHL, EMBASE, The Cochrane Database of Systematic Reviews,

The Cochrane Central Register of Controlled Trials, Health Technology


23

Assessment, and AMED databases. Inclusive dates were January 1998

through January 2008.

Search strategies. A sensitive search strategy was developed by the GDG;

search terms and strategies have been published on the guideline website

for stakeholder review and comment. Full lists of articles identified by

these search strategies were also available for stakeholder review. SWGs also

conducted additional focused searches to ensure the full depth and breadth

of their topic area had been covered.

Inclusion criteria. All references retrieved by the electronic literature search

were screened by the GDG based on the following inclusion criteria. The

articles must have been primarily focused on pressure ulcer prevention,

risk assessment, and treatment in human subjects. The articles must have

been published in a peer reviewed journal. An abstract must have been

available. The studies should have used one of the following designs:

randomised controlled trials, controlled clinical trials, quasi-experimental

studies, cohort studies, cross-sectional studies, survey studies, prevalence

or incidence studies, case-control studies, and case series. At least 10

subjects must have been included in any case series. Systematic reviews or

meta-analyses were included if they used the Cochrane methodology. SWG

reviewers were asked to refer to the original articles cited in systematic

reviews and meta- analyses. Studies using established qualitative

methodologies were also considered as appropriate to the research

question. There was no restriction on the basis of language of a study.

Economic evaluations were excluded because of limitations in existing

literature and differences in health care systems across countries. Studies not

initially identified by bibliographic searches yet meeting these criteria were

included when listed in reference lists of identified articles and

recommended by stakeholders.

Direct vs. indirect evidence. Studies of pressure ulcers in humans were

considered “direct evidence” and were required to support an A or B

strength-of-evidence rating. When studies of pressure ulcers in humans

were not available, studies in normal human subjects, human subjects

with other types of chronic wounds, or laboratory studies using animals

could be used to support recommendations with a C strength-of-evidence

rating. The majority of the recommendations with a C strength-of-evidence


24

rating are supported by indirect research or previous guidelines, and do

not rely solely on expert opinion.

Step 2: Evaluating the Evidence

Data abstraction. The full papers of selected references were obtained and

divided according to topic and then sent to the relevant SWGs. The SWGs

consist of trustees and members of the EPUAP and NPUAP. The members of

the SWGs created evidence tables and scored a methodology checklist

developed by the GDG for each study. The template of the evidence table

consisted of reference of the study, type of study, sample, intervention(s),

outcome measures and length of follow-up, results, and limitations.

Methodological quality. The methodological quality of each study was

assessed by two reviewers using methodology checklists that were

developed by the GDG, based on the Scottish Intercollegiate Guidelines

Network(1). These checklists helped the reviewers to judge the quality of the

study. Evaluation of study quality concentrated on the internal and external

validity of the studies. The following quality criteria were considered: internal

validity of the study, clear and appropriate research question(s), selection

of subjects, allocation, baseline comparability, outcomes, blinding,

confounding factors, statistical analysis, overall assessment of the study, and

bias. There were different types of methodology checklists based on the

study design: cross-sectional/survey/prevalence studies, case- control

studies, cohort studies, randomized controlled trials, quasi-experimental

study, diagnostic studies, and systematic reviews/reviews/meta-analyses. All

papers were evaluated by two members of the SWGs. The GDG completed a

quality check of a random sample of 10% of the completed evidence tables.

Level of evidence. The level of evidence was noted for each study, using a

classification system adapted from Sackett(2). Sackett and his colleagues

have developed more sophisticated and complex classification systems(3);

however, the elegant simplicity of their early work provided greater

consistency when used with a large international group of reviewers.

Table 1. Level of Evidence for Individual Studies

1 Large randomized trial(s) with clear-cut results (and low risk of error)

2 Small randomized trial(s) with uncertain results (and moderate to high

risk of error)


25

3 Non randomized trial(s) with concurrent or contemporaneous controls

4 Non randomized trial(s) with historical controls

5 Case series with no controls. Specify number of subjects.

Step 3: Drafting Recommendations Each SWG formulated conclusions about the body of available evidence

based on the evidence tables and quality evaluations. Evidence tables from

previous guidelines were also made available to the treatment SWGs to

ensure the full body of scientific literature was reviewed. A first draft of

recommendations was developed by the respective SWGs. The GDG

reviewed the draft recommendations, making revisions as necessary.

To ensure uniformity and internal consistency in the final guideline, the

GDG provided the following guidance. Each recommendation should start

with an action verb and be a simple, short, direct, declarative statement,

free of jargon. Multiple complex recommendations were broken down into

a series of smaller, discrete recommendations. Authors were advised to

start with broad, directive statements, followed by subsequent statements

with more detail (how, when, how often). Spelling was determined based

on the conventions of American English. The GDG reviewed all

recommendations to ensure the wording of the recommendations

accurately translated available research into best practice while being

sensitive to the many different individual cultures and professional standards

represented among the international audience for these guidelines.

The term “individual” was used to describe the patient, client, resident, or

person with a pressure ulcer or at risk for a pressure ulcer. The term

“professional” was used when referring to the health care professional

providing professional health care services to the individual. The disciplines

of professionals performing a given service may vary from country to

country based on the laws and regulations governing health care providers.

Products available in one country may not be available in another. Individual

circumstances vary; the professional and individual should use these

guidelines to meet the goals and wishes of the individual within the context

of his or her unique circumstances. In all cases, the recommendations

should be used to guide the professional in providing care to the individual


26

with a pressure ulcer or at risk for developing a pressure ulcer; this

document is not intended as a standard or mandate for care.

Step 4: Assigning Strength of Evidence Ratings Strength of evidence ratings were then assigned to recommendations. This

rating identifies the strength of cumulative evidence supporting a

recommendation. The strength of evidence supporting the recommendation

is not the same as the strength of the recommendation. For example, there

are no randomized controlled trials in humans with pressure ulcers that

evaluate debridement vs. no debridement. Therefore, this recommendation

would have a relatively low strength of evidence supporting the

recommendation, yet the recommendation is strongly recommended in

many clinical situations based on evidence from studies of other types of

chronic wounds, proof of principle from basic science research, and/or

expert opinion.

Table 2. Strength of Evidence Rating for Each Recommendation

A The recommendation is supported by direct scientific

evidence from properly designed and implemented

controlled trials on pressure ulcers in humans (or humans

at-risk for pressure ulcers), providing statistical results that

consistently support the guideline statement (Level 1

studies required).

B The recommendation is supported by direct scientific

evidence from properly designed and implemented clinical

series on pressure ulcers in humans (or humans at-risk for

pressure ulcers), providing statistical results that

consistently support the recommendation. (Level 2, 3, 4, 5

studies)

C The recommendation is supported by indirect evidence (e.g.,

studies in normal human subjects, humans with other types

of chronic wounds, animal models) and/or expert opinion.

A strength of evidence rating of A requires Level 1 studies of humans with

pressure ulcers or at risk for pressure ulcers. This rating is consistent with

recommendations derived using the Cochrane methodology. A strength of

evidence of B requires Level 2, 3, 4, and/or 5 studies in these populations.

Recommendations supported by A and B strength of evidence ratings were


27

developed first. This strategy provided recommendations with very direct

evidentiary support, but the guideline lacked the breadth and depth of

guidance necessary to provide care.

Previous guidelines have filled this “evidence gap” with “expert opinion” and

given a strength of evidence of C. In developing this guideline, evidence gaps

were explicitly identified. Systematic literature reviews were then con-

ducted to identify indirect evidence from studies of normal subjects,

studies with intermediate or surrogate outcomes, studies of humans

with other types of chronic wounds, and animal studies. For many

recommendations, indirect evidence has been identified to support C

strength of evidence ratings. In the absence of indirect evidence, consensus

from previous guidelines often supports C strength of evidence ratings,

providing a broader base of expert opinion than that available in the SWGs

and GDG. All recommendations, including those supported solely by expert

opinion have been reviewed by stakeholders.

Step 5: Summarizing Supporting Evidence The SWGs summarized the evidence supporting each recommendation. All

recommendations with a strength of evidence rating of A or B required an

explicit summary of one or more studies of human subjects with pressure

ulcers or at risk for pressure ulcer development. The level of evidence for

each study is also identified.

The summary statements for recommendations with a strength of evidence

of C clarify whether the recommendation was supported by (1) indirect

evidence from studies of normal subjects, studies with intermediate or

surrogate outcomes, studies of humans with other types of chronic

wounds, and animal studies or other basic bench research, (2) expert

opinion supported by previous evidence-based guidelines, and/or (3) the

expert opinion of the SWG and GDG members as reviewed by international

stakeholders. Evidence gaps identified in these summary statements serve

as an agenda for future research efforts.

Conclusion The EPUAP and NPUAP Guideline Development Group is pleased to present

the EPUAP-NPUAP Pressure Ulcer Prevention and Treatment Guideline. The


28

Clinical Practice Guideline version provides evidence-based

recommendations and brief summaries of the evidence and/or

rationale supporting the recommendations. The Quick Reference Guide

version provides basic recommendations only; it has been translated into

several languages other than English. Educational materials and consumer

guides will be developed in multiple languages to meet the needs of

different populations, in different settings, and in different cultures.

Technical Reports for both prevention and treatment provide evidence table

summarizing articles meeting inclusion criteria.

References (1) Critical Appraisal: Notes and Checklists. Edinburgh: Scottish Intercollegiate

Guidelines Network; [cited September 24, 2009]; Available from: http://

www.sign.ac.uk /methodology/ checklists.html.

(2) Sackett DL. Rules of evidence and clinical recommendations on the use of

antithrombotic agents. Chest. 1989;95(2 Suppl):2S-4s.

(3) Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-based medicine: How

to practice and teach EBM. Third ed. Toronto: Elsevier Churchill Livingstone; 2005.

http://www.sign.ac.uk/


29

NPUAP-EPUAP Pressure Ulcer Classification System

As part of the guideline development process, the NPUAP and EPUAP

developed a common international definition and classification system for

pressure ulcers. Over the past several years, members of the two

organizations have had ongoing discussions about the many similarities

between the NPUAP and EPUAP pressure ulcer grading/staging systems. As

we release an international pressure ulcer prevention and treatment

guideline, we consider this the ideal time to develop a common

classification system that can be used by the international community.

Staging/grading implies a progression from I to III or IV, when that is not

always the case. We attempted to find a common word to describe the

stage or grade and could not do so. “Category” was suggested as a neutral

term to replace “stage” or “grade.” Although foreign to those accustomed

to other terms, “category” has the advantage of being a non-hierarchical

designation, allowing us to free ourselves from the mistaken notions of

“progressing from I to IV” and “healing from IV to I.”

We recognize that there is a familiarity to the words “stage” and “grade,” and

therefore we are proposing to use whatever word (e.g., stage, grade, or

category) is most clear and understood. However, we see that the most

significant benefit from this collaboration is that the actual definitions of

pressure ulcers and the levels of skin-tissue injury are the same, even

though one group may label the pressure ulcer as a “stage” or “grade” or

“category.”

We have agreed upon four levels of injury. Recognizing that the terms,

”unclassified/unstageable” and ”deep tissue injury” are generally graded as

“IV” in Europe, NPUAP has agreed to put them separately in the text in the

guideline. This difference will remain an issue when comparing cross-

country data.

Common Definition of Pressure Ulcers A pressure ulcer is localized injury to the skin and/or underlying tissue,

usually over a bony prominence, as a result of pressure or pressure in


30

combination with shear. A number of contributing or confounding factors

are also associated with pressure ulcers; the significance of these factors

has yet to be elucidated.

NPUAP/EPUAP Pressure Ulcer Classification System

Category/Stage I: Non-blanchable redness of intact skin

Intact skin with non-blanchable erythema of a localized area, usually over a

bony prominence. Discoloration of the skin, warmth, edema, hardness, or

pain may also be present. Darkly pigmented skin may not have visible

blanching. Further description: The area may be more painful, firmer or

softer, or warmer or cooler than adjacent tissue. Category/Stage I may be

difficult to detect in individuals with dark skin tones. This may indicate an

at-risk individual.

Category/Stage II: Partial Thickness skin loss or blister

Partial thickness loss of dermis presenting as a shallow open ulcer with a

red/pink wound bed, without slough. It may also present as an intact or

open/ruptured serum-filled or sero-sanginous-filled blister.

Further description: Presents as a shiny or dry shallow ulcer without slough

or bruising. This category/stage should not be used to describe skin tears,

tape burns, incontinence-associated dermatitis, maceration, or excoriation.

Category/Stage III: Full thickness skin loss (fat visible)

Full thickness tissue loss. Subcutaneous fat may be visible, but bone,

tendon, or muscle are not exposed. Some slough may be present. It may

include undermining and tunneling.

Further description: The depth of a Category/Stage III pressure ulcer varies

by anatomical location. The bridge of the nose, ear, occiput, and malleolus

do not have (adipose) subcutaneous tissue, and Category/Stage III ulcers can

be shallow. In contrast, areas of significant adiposity can develop extremely

deep Category/Stage III pressure ulcers. Bone/tendon is not visible or

directly palpable.

Category/Stage IV: Full thickness tissue loss (muscle/bone visible)

Full thickness tissue loss with exposed bone, tendon, or muscle. Slough or

eschar may be present. It often includes undermining and tunneling.


31

Further description: The depth of a Category/Stage IV pressure ulcer varies

by anatomical location. The bridge of the nose, ear, occiput, and malleolus

do not have (adipose) subcutaneous tissue, and these ulcers can be

shallow. Category/Stage IV ulcers can extend into muscle and/or supporting

structures (e.g., fascia, tendon, or joint capsule), making osteomyelitis or

osteitis likely to occur. Exposed bone/muscle is visible or directly palpable.

Additional Categories for the USA

Unstageable/unclassified: Full thickness skin or tissue loss – depth

unknown

Full thickness tissue loss in which actual depth of the ulcer is completely

obscured by slough (yellow, tan, gray, green, or brown) and/or eschar (tan,

brown, or black) in the wound bed.

Further description: Until enough slough and/or eschar is removed to

expose the base of the wound, the true depth cannot be determined, but

it will be either a Category/Stage III or IV. Stable (dry, adherent, intact,

without erythema or fluctuance) eschar on the heels serves as “the body’s

natural (biological) cover” and should not be removed.

Suspected Deep Tissue Injury – depth unknown

Purple or maroon localized area of discolored, intact skin or blood-filled

blister due to damage of underlying soft tissue from pressure and/or shear.

Further description: The area may be preceded by tissue that is painful,

firm, mushy, boggy, or warmer or cooler than adjacent tissue. Deep tissue

injury may be difficult to detect in individuals with dark skin tones. Evolution

may include a thin blister over a dark wound bed. The wound may further

evolve and become covered by thin eschar. Evolution may be rapid exposing

additional layers of tissue even with treatment.


32

Table 1. Classification of Pressure Ulcers References Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Allcock N, Wharrad H,

Nicolson A. Interpretation

of pressure-sore

prevalence. J Adv Nurs.

1994;20(1):37-45.

Study data were

collected by the

infection control link

nurses (ICLN) who all

attended training

sessions to inform

them of the aims and

methods of the study

as well as receiving

education on the

grading system

803 patients on wards

day of study

The training involved a

revision of the structure of

the skin followed by a

discussion of the grading

system and an opportunity

to practice using the grading

system using color slides of

sores collected prior to the

study

It was not possible to assess the

accuracy of pressure-sore

identification due to the resources

available The reliability of the ICLNs

pressure sore grading was estimated

using a series of six pictures not

previously seen by the ICLN

This showed that the distinction

between grades 1 and 2, 3 and

4, and 5 and 6 were difficult The

number correct for each grade was

49%, 47%, 46%, 32%, 36% and 42%

for grades 1-6 respectively If the

grades are combined into three

groups the grading of sores was

much more accurate, grade1 & 2

98% correct, grade 3 & 4 68%

correct and grade 5 & 6 79% correct

This suggests that the

grading scheme used may

have had too many

categories to be reliable,

although the difficulties of

grading from a

photograph, due to the

difficulty in judging depth

and other factors, needs

to be taken into account

Beeckman D, Schoonhoven

L, Boucqué H, Van Maele

G, Defloor T. Pressure

ulcers: e-learning to

improve classification by

nurses and nursing

students. J Clin Nurs.

2008;17(13):1697-707.

Random assignment

of convenience

sample to e-learning

of the EPUAP grading

system for pressure

ulcers. Control group

received instruction

in the classroom

Nursing students

Qualified nurses from 7

hospitals, 7 nursing

homes, 1 home care

agency and 5 schools of

nursing

Both groups received similar

illustrations, tests and

instruction

Both groups tested on 20

photographs of normal skin

(1), blanchable erythema

(1), stage I (3), II (3), III (3),

IV (3), moisture lesions (3)

and combined ulcers (3)

(both moisture and

pressure)

No difference in pretest between

groups

Self-assessment of expertise of

identifying ulcers

Reliability improved with training

but was not perfect, problems

distinguishing stages and IAD from

pressure ulcers

E-learning and classroom learning

led to same outcomes

Beeckman D, Schoonhoven

L, Fletcher J, Furtado Kt,

Gunningberg L, Heyman H,

et al. EPUAP classification

system for pressure ulcers:

European reliability study.

J Adv Nurs.

2007;60(6):682-91.

Survey of 1452

nurses from 5

European countries

familiar with EPUAP

PrU classification

system

Classified 20 photographs of

normal skin (1), blanchable

erythema (1), stage I (3), II

(3), III (3), IV (3), moisture

lesions (3) and combined

ulcers (3) (both moisture

and pressure)

Pressure ulcers were often classified

erroneously and only a minority of

nurses reached a substantial level of

agreement: 33% reached moderate

agreement and only 5% reached

high agreement with known grade

or skin lesion. Grade 3 lesions were

regularly classified as grade 2. Non-

blanchable erythema was frequently

assessed incorrectly as blanchable

erythema. Furthermore, the

differential diagnosis between

moisture lesions and pressure ulcers

appeared to be complicated

Briggs S-L. How accurate

are RGNs in grading

pressure ulcers? Br J Nurs.

2006;15(22):1230-4.

Describe the

accuracy of

registered general

nurses on pressure

ulcer grades using

EPUAP grading

N = 52 In the pre-test only one (1.9%)

respondent fell in the group which

achieved between 16-20 (80%)

correct answers and the number in

this group rose to four (7.7%)

respondents in the post-test. The


33

References Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

system

What was the effect

of education on the

accuracy?

biggest increase was in the group

that scored between 11-15 (55% to

75%) correct answers; this group

rose from eight (15.3%) in the pre-

test to 29 (55.7%) in the post-test.

For those who scored between 6

and 11) correct answers, this group

reduced from 23 (44.2%) in the pre-

test to 18 (34.6%) in the post-test.

The results of the study indicated

the level of accuracy of pressure

ulcer grading was poor in the pre-

test but markedly improved in the

post-test.

Defloor T, Schoonhoven L.

Inter-rater reliability of the

EPUAP pressure ulcer

classification system using

photographs. J Clin Nurs.

2004;13(8):952-9.

Development and

validity testing of a

series of

photographs of

pressure ulcers and

moisture lesions

using the EPUAP to

establish a "gold

standard" for

accuracy of diagnosis

7 researchers, 20 staff

members and 17

pressure ulcer nurses

Photographs were shown to

the second group and then

differences were measured

Deviations in expert scores occurred

in 5.9% of the cases, but 33.3% of

the differences was only one grade

of difference from the gold

standard.

In 3.2% of the cases the deviation is

more than two grades and in 7.3%

of the cases the lesion is classified as

an incontinence lesion. Conclusion

was that photographs were accurate

and could be used to measure

accuracy of pressure ulcer grading.

An inclusion of ‘‘unclear’’ in the

calculation will artificially raise the

level of agreement

for difficult cases.

Defloor T, Schoonhoven L,

Vanderwee K, Weststrate

J, Myny D. Reliability of the

European Pressure Ulcer

Advisory Panel

classification system. J Adv

Nurs. 2006;54(2):189-98.

examine the

interrater and

intra-rater reliability

of classifying

pressure ulcers

according to the

EPUAP classification

system when using

photographs

of pressure ulcers

and incontinence

lesions

Phase 1: 65 photos

were presented in a

random order to 473

nurses who were

participating at a

Congress for Wound

Care in Belgium, the

Netherlands and

Finland.

Phase 2: Eighty-six

nurses from a university

hospital in Belgium

participated in the

A set of 56 photographs of

normal skin, blanchable

erythema, pressure ulcers

and incontinence lesions

was used.

If erythema was visible on a

photograph, a second

photograph was also

shown. On this second

photograph a transparent

pressure disk was pressed

onto the erythema so that

the extent to which the

The multi-rater Kappa for the 473

nurses was 0. 37 (P < 0.001). If only

the pressure ulcer photos (N = 37)

were considered, the average Kappa

and the weighted Kappas varied

between 0.41 and 0.50. The average

percentage agreement was 55.6%

and 15.7% of the photos were

scored one grade too high or too

low.

The average Kappa did not differ

statistically significantly between

the nurses who received training on


34


Length of Follow-up

Results Limitations

second phase. The

sequential intra-rater

reliability was evaluated

by presenting the same

56 photos twice with an

interval of 1 month. On

both occasions the

photographs were

presented in a different

random order.

erythema was blanchable

was visible. The

photographs were

presented once and the

nurses were asked to

classify the photographs as

normal skin, blanchable

erythema, non-blanchable

erythema (grade 1

pressure ulcer), blister

(grade 2 pressure ulcer),

superficial pressure ulcer

(grade 3), deep pressure

ulcer (grade 4) or

incontinence lesion. Also

the option ‘do not know’

was given.

At the outset the definitions

of grades of pressure ulcers,

as categorized by the

EPUAP, were presented to

the participants in a

standardized way.

pressure ulcers and those who did

not. P values varied between 0.13

and 0.63.

Grade 1 was the most frequently

wrongly classified grade (54.5%;

3091/5676 observations). In 7.9% of

the observations nonblanchable

erythema was confused with

blanchable erythema, and in 19.6%

of cases with incontinence lesions.

The incontinence lesions were also

frequently wrongly assessed

(44.3%; 1676/3784). In 20.6% of the

observations they were assessed as

superficial pressure ulcer (grade 3),

in 4.2% as blister (grade 2) and in

6.3% as deep pressure ulcer (grade

4).

An inclusion of ‘‘unclear’’ in the

calculation will artificially raise the

level of agreement for difficult

cases.

Gajewski BJ, Hart S,

Bergquist-Beringer S,

Dunton N. Inter-rater

reliability of pressure ulcer

staging: ordinal probit

Bayesian hierarchical

model that allows for

uncertain rater response.

Stat Med.

2007;26(25):4602-18.

Data from 20

hospitals. Hospitals

deviated from our

specification of n =15

PrUs and p =6 raters

To construct a model to

estimate the reliability

of rating PrUs from

patients in NDNQI

hospitals. Stages I to IV

are ordinal and

unstageable, because it

combines III and IV (and

in this case DTI) does

not fit this numeric

relationship

Wide variation in reporting

unstageable PrU in hospitals

Classified DTI as unstageable

Hart S, Bergquist S,

Gajewski B, Dunton N.

Reliability testing of the

National Database of

Nursing Quality Indicators

pressure ulcer indicator. J

Nurs Care Qual. 2006;21(3

(Print)):256.

256 individuals at 48

randomly sampled

National Database of

Nursing Quality

Indicators (NDNQI)

member hospitals.

Approximately 54%

(n = 26) of the

participating

hospitals were

academic medical

Part 1 of the test asked

participants to identify

whether the wound was

a pressure, venous,

arterial, or diabetic foot

ulcer.

For part 2, individual

participants were asked

to stage the pressure

ulcer in each of the

17 photographs or to

A 3-part criterion-

referenced test was created

in collaboration with

experts in wound care and

instrument design. High-

quality digital pictures of

ulcerous wounds were used

in this study. Nineteen of

the 25 pictures were

obtained from and used

with permission from the

Most raters correctly identified

pressure ulcers from photographs of

ulcerous wounds, but frequently

misclassified the type of non-

pressure ulcer wound. Variations in

K agreement were found between

certified and noncertified nurses.

Wound, continence, and/or ostomy

care certified nurses had higher K

values (/c = 0.66, SD = 0.18) than

noncertified nurses (K = 0.54,


35


Length of Follow-up

Results Limitations

centers or teaching

hospitals and 33%/

held Magnet status.

classify it as

unstageable.

Participants were

instructed to use

NPUAP guidelines when

staging the wound or

classifying it as

unstageable.

For part 3 of the test,

participants were asked

to read 5 scenarios and

determine from each

whether the patient's

pressure ulcer was

nosocomial or

community acquired.

NPUAP Guidelines of the

NPUAP and the AHRQ for

pressure ulcer staging and

expert opinion were used to

assess and stage ulcers in

each picture.

The first part of the test

(PrU Identification)

contained 7 pictures of

ulcerous wounds: 3 venous

ulcers, 2 pressure ulcers, 1

arterial ulcer, and 1 diabetic

foot ulcer. The second part

(PrU Stage) contained 18

pictures of pressure ulcers.

During pilot testing, this

section contained 4 pictures

of stage I pressure ulcers, 3

pictures of stage II pressure

ulcers, 5 pictures of stage III

pressure ulcers, 5 pictures

of stage IV pressure ulcers,

and 1 picture of an

unstageable pressure ulcer.

The third part (PrU Source)

contained 5 scenarios that

described a patient's course

of hospitalization.

Two versions of the test

were created because

assessment of the reliability

of pressure ulcer staging

from Web-based

photographs was a new

methodology and subject to

2 limitations relative to in-

person assessment.

First, even high-quality

digital images are 2-

dimensional and will not

provide all of the

information available from

direct observation.

Second, the images

available to raters were

SD - 0.18). When data were

collapsed to binary values (pressure

ulcer/not pressure ulcer), K

agreement was 0.84 (SD = 0.25),

with little variation in K values

between wound, continence, and/or

ostomy certified nurses (p< = 0.92,

SD = 0.15) and noncertified nurses

(p = 0.82, SD = 0.27), indicating near

perfect reliability. When the test did

not include wound descriptors, the

adjusted K agreement for pressure

ulcer staging by nurses who were

certified in wound, continence,

and/or ostomy care was 0.66 (SE —

0.04) compared with 0.54 (SE = 0.03)

for noncertified nurses. When the

test included wound descriptors, the

adjusted K value for those certified

in wound, continence, and/or

ostomy care was 0.83 (SE = 0.03)

compared with 0.71 (SE = 0.02) for

noncertified nurses.

Their conclusion states that the

study results suggest that NDNQI

data on pressure ulcers can be used

as an indicator of nursing care

quality and as a tool for guiding

quality improvement initiatives.


36


Length of Follow-up

Results Limitations

dependent on the quality of

their computer monitors. To

address the 2-dimensional

limitation, the first test

version contained a short

narrative description

(wound descriptor) of each

pressure ulcer in part 2 of

the test. This was done to

provide contextual

information about the

wound ordinarily available

to the rater through direct

wound observation.

Specifically, information

about wound size, depth,

surface characteristics, and

surrounding tissue were

included in the narrative

description that

accompanied the pressure

ulcer photographs. While

this additional information

may have provided details

typically available to an in-

person rater, it might

also have cued raters to

consider wound

characteristics that might

not have been noticed

without prompting.

Therefore, the second

version of the test excluded

wound descriptors in part 2

to examine their effect on

the reliability of pressure

ulcer staging and enhance

the comparability of

findings to previous

research studies.

It was anticipated that the

reliability results from the

version containing wound

descriptors would be higher

than the picture-only


37


Length of Follow-up

Results Limitations

version, and that the 2

versions of the test would

bracket the reliability

resulting from bedside, in-

person assessments.

Houwing RH, Arends JW,

Canninga-van Dijk MR,

Koopman E, Haalboom JRE.

Is the distinction between

superficial pressure ulcers

and moisture lesions

justifiable? A clinical-

pathologic study. Skinmed.

2007;6(3):113-7.

12 lesions with

blanchable erythema

classified as moisture

lesions

Punch biopsy taken 5

mm from superficial

skin defect in

incontinence lesions

and within stage I

4 of the lesions were due to

ischemia and 8 were chronic

irritation

Stages I through IV are associated

ischemic pathology. Moisture

lesions are associated with a chronic

irritation

Nixon J, Cranny G, Bond S.

Pathology, diagnosis, and

classification of pressure

ulcers: comparing clinical

and imaging techniques.

Wound Repair Regen.

2005;13(4):365-72.

A total of 143

patients consented

to participate in the

pilot study (April to

July 1998) and the

main study

(September 1998 to

May 1999), including

93 elective and 50

acute patients.

To detect differences in

mean blood flow

perfusion units)

between clinical skin

grades— Skin lesions

classified as:

0 No skin changes

1a Redness to skin

(blanching)

1b Redness to skin

(nonblanching)

1bþ Redness to skin

(nonblanching) plus one

or more:

Pain

Induration

Heat

Edema

Discoloration

(specify)

2 Partial thickness

wound involving

epidermis/dermis only

3 Full thickness wound

involving subcutaneous

tissue


through subcutaneous

tissue to muscle or

bone

5 Black eschar

Skin on the buttocks and

sacrum was assessed

immediately

postoperatively and daily

until discharge using a

combination of the

following clinical and

physiological measures:

clinical skin assessment

preoperatively,

postoperatively, and daily

until discharge), laser

Doppler imaging (1/2 hour

and 1 hour postoperatively),

and laser Doppler imaging

of Grade 1b and Grade 1bþ

skin areas observed during

follow-up, where feasible.

Histogram was created of pixels at

each level of tissue injury.

Similarness of pixel levels was

compared. There was a difference

between the levels, with grade iB

(DTI?) the most different


38


Length of Follow-up

Results Limitations

Plus a minimum

sample size of 42 scans

was estimated using

pilot study data. This

was based on an

analysis of variance

with 95 percent power

at the 5 percent

significance level.

Nixon J, Thorpe H, Barrow

H, Phillips A, Andrea

Nelson E, Mason SA, et al.

Reliability of pressure ulcer

classification and

diagnosis. J Adv Nurs.

2005;50(6):613-23.

A total of 378 paired

assessments was

undertaken by 116

nurses for the inter-

rater reliability

assessments during

the period from

December 2000 to

February 2001

0 No skin changes

1a Redness to skin

(blanching)

1b Redness to skin (non-

blanching)

2 Partial thickness wound

involving

epidermis/dermis only (i.e.

skin break or blister)


involving subcutaneous

tissue


through subcutaneous

tissue to muscle or bone

5 Black eschar

Agreement was measured between

CRNs and WNs for the 2396 paired

site assessments for all grades.

There were a total of 508 (21.2%)

disagreements between CRNs and

WNs: 419 were one grade different

(such as 0/1a, 1a/1b and so on), 68

were two grades different [including

0 and 1b (21), 1a and 2 (46) and 3

and 5 (1)], and 21 were more than

two grades different [including 0

and 2 (13), 0 and 3 (1), 1a and 3 (3),

2 and 5 (4)]

Russell LJ, Reynolds TM.

How accurate are pressure

ulcer grades? An image-

based survey of nurse

performance. J Tissue

Viability. 2001;11(2):67.

Thirty images were

selected and classified

with the EPUAP scale,

establishing the gold

standard through

consensus of an expert

panel. Twelve images

were then used for the

study in paper form.

These images were

classified by 97 of 200

contacted nursing

experts from EPUAP

and Great Britain.

About 61.9% of the grades agreed

with the gold standard, the mean

deviation from the gold standard

was 0.49 (standard deviation 0.25).

Stausberg Jr, Lehmann N,

Krager K, Maier I, Niebel

W. Reliability and validity

of pressure ulcer diagnosis

and grading: an image-

based survey. Int J Nurs

No pressure ulcer (grade 9

in the analysis);

Pressure ulcer grade 1:

Localized erythema of the

skin; Pressure ulcer grade 2:

Loss of skin; Pressure ulcer

Seven participants with 100

assessments each led to 700 grades.

Comparing every two participants

with each other led to 21 pairs with

2100 single comparisons. Half of the

results related to the foot/heel


39


Length of Follow-up

Results Limitations

Stud. 2007;44(8):1316-23.

grade 3: Deep loss of skin,

muscles and tendons are

visible and possibly

affected; Pressure ulcer

grade 4: Deep loss of skin

with affection of bones.

region, the other half to the

buttock/hip region (350 grades and

1050 single skin comparisons each).

In about one-third of the images, all

participants agreed concerning the

grade, in about 80% at least five

participants agreed.

Verdu J. Can a decision

tree help nurses to grade

and treat pressure ulcers?

J Wound Care.

2003;12(2):45-50.

Random assignment

of 66 nurses to a

decision tree to

classify pressure

ulcers. Nurses

randomly selected

from 100 at the

General University

Hospital of Elche,

Alicante, Spain. All

had a similar level of

experience and often

cared for patients

with chronic wounds.

At baseline participants

were given a sealed

envelope containing

three clinical case

studies, each of which

briefly described the

health status of a

patient and his or her

pressure ulcer, and

included photographs

of the site and aspect of

the wounds.

Of the 66 nurses, 34 (51.5%)

were assigned to the

control group and 32

(48.5%) to the experimental

Group

Case 1 is a stage I or II

Case 2 is a stage III

Case 3 is a stage IV with

necrotic tissue

Photos are blurred

Case I* Case II** Case III***

ConNo.

(%)

Exp.

No. (%)

Con No.

(%)

Exp. No.

(%)

Con No.

(%)

Exp. No.

(%)

Accurate 29 (85.3) 25 (78.1) 18 (52.9) 21 (65.6) 21 (61.8) 14 (43.8)

Inaccurate 5 (14.7) 7 (21.9) 16 (47.1) 11 (34.4) 13 (38.2) 18 (56.2)

There was no statistically significant difference between the grades selected by the two groups.

Overall accuracy rates were:

● Case I: 81.8% (54/66)

● Case II: 59.1% (39/66)

● Case III: 53.0% (35/66)


40

Table 2. Assessment and Monitoring of Healing Direct Evidence

Reference Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Brown GS. Reporting

outcomes for stage IV

pressure ulcer healing: a

proposal. Adv Skin Wound

Care. 2000;13(6):277-83.

Also in 09 Dressings Table

Retrospective

analysis.

Measurement of 10

fully healed stage IV

pressure ulcers in the

pelvic area of 9 patients

were examined

retrospectively.

The wounds were treated

by:

Eschar removal with sharp

debridement. Wet-to-dry

dressing for further

debridement of tenacious,

fibrous necrotic tissue was

used in some cases.

Sodium chloride-

impregnated gauze was

used as the primary

dressing with calcium

alginate for heavily

exudating wounds.

A hyper-colloid wafer or

foam dressing was used

upon sufficient contraction

and filling of the wound

with new tissue until full

healing.

Date of start of treatment

was considered to begin

upon: (1) initial examination

with heavy to no fibrous

necrotic tissue or slough, if

no Escher was covering the

wound, or (2) debridement

of at least 90% of Escher

covering the wound.

The demographics of the patients

and theirs wound measurements,

which were taken weekly by 1 of

two wound, ostomy, and continence

nurse during an 18 months period,

were optioned for the analysis.

Linear measurements were used to

calculate the area of the wound.

Volume of the wound was not used.

Average daily reduction in the

wound area was determined for all

10 wounds (initial wound area/ # of

days till full healing). Then the

wounds were stratified into 3

groups: small, medium, and large.

To create and analyze wound

healing curves; individual healing

curve was examined.

Strong link between initial wound size

and healing rate (correlation

coefficient = 0.806).

Lower correlation coefficient

between initial wound size and total

days to full healing (0.720). Leading to

the conclusion that as initial wound

area increases the, the average daily

wound area reduction also increases.

The wound healing curves begin on a

gradual slop but quickly dive

downward as the wound contracts. In

the last phase of epithelialization, the

rate slows considerably. The time to

reach 50% reduction in wound area

for the large, medium, and small

groups was: 26.7%, 42.2%, and 30.1%

of total healing time. The last 10 % of

the healing for the large, medium,

and small groups took 32. %, 33%,

and 33.4% of the total healing time,

respectively. The authors

recommended the use of the 10%

interval data or monogram for

comparing healing rates

prospectively.

Cutler NR, George R,

Seifert RD, Brunelle R,

Sramek JJ, McNeill K, et al.

Comparison of quantitative

methodologies to define

chronic pressure ulcer

measurements. Decubitus.

1993;6(6):22-30.

Prospective study 17 patients each had at

least one full-thickness

pressure ulcer ( stage III

or VI) that had been

present for at least four

weeks, and

approximately 2 to 150

cm2 in area, not

infected, not include

exposed bone or

cellulitis around the

ulcer, and the patients

The ulcers were assessed by

the same nurse at the start

of the study and weekly

thereafter for four weeks.

Computer- assisted

planimetry from the tracing

and photographs, and

calculations from the direct

measurements determined

ulcer areas. Wounds were

stratified according to their

size. Ulcer volumes were

The relationship between the ulcer

measurements, the amount and

type of variability within each

measurement, and the changes of

ulcer size during the 4 weeks of

follow-up were examined

statistically.

Areas determined from all

methodologies were very similar

(coefficient > .94, p = .01). The areas

obtained from dimension

measurements from photographs and

tracing slightly over-estimated the

area of the ulcers compared to the

ulcers when compared to the area

obtained by computer-assisted

planimetry (mean difference about

1.5 cm2). There was good agreement

between volumes calculated from

Area calculated from the

dimension

measurements assumed

all the ulcers were

elliptical in shape. No

attempt was made to

base area calculation on

any other shaped

differentially.


41


Length of Follow-up

Results Limitations

are not critically ill. calculated by means of

bedside measurements and

Jeltrate volume calculated

weight.

bedside measurements and volumes

determined by Jeltrate impression

(r=.892). Jeltrate impression volumes

tended to yield smaller

measurements than calculated

volumes, especially in larger than 10

cm3 wounds. There was tendency for

Jeltrate impression volume to over

predict calculated volumes in smaller

wounds less than 10 cm3.

van Rijswijk L, Polansky M.

Predictors of time to

healing deep pressure

ulcers. Ostomy Wound

Manage. 1994;40(8):40-2,

4, 6-8 passim.

Secondary analysis. 48 patients:

25 men and 22 women.

With 56 full thickness

stage III and IV that

were dressed with

hydrocolloid dressing

for mean of 56 days

prior to the study

enrollment.

Several analysis methods

developed and used on

secondary data:

Kaplan-Meier time until

healing curves were

calculated for time until 50,

80, and 100% healing based

on the ulcer tracing

obtained.

Reduction in ulcer area was

calculated as reduction in

area % from baseline,

controlled by baseline area.

The median time until

healing was calculated for

all patients combined and

as a function of each patient

and ulcer characteristics at

baseline and after two

weeks of treatment.

All calculations performed

50, 80, & 100% healing.

A stepwise Cox proportional

hazards’ model for

prognosis factors of time

until healing 100%.

The relationship between outcome

(time to healing deep pressure

ulcer) and the covariates were

assessed (patient and wound

characteristics).

Patients’ characteristics include:

general health condition, mental

statues, mobility, skin condition,

activity level, body build and overall

skin condition, nutritional status.

Wound characteristics include:

aspects of ulcer margin, the

pressure granulation, or necrotic

tissue and depth were assessed at

baseline and every dressing change.

Kaplan-Meier time until 100 % healing

time curve showed that the median

time to healing was 69 days. Healing

can be expected to be seen in 25% of

the patients after 50 days, where 75%

of patients can be expected to heal

after 243 days. A 50% reduction in

wound size can be expected after 15

days, where half of all wounds

exhibited an 80 % reduction in ulcer

area after 40 days.

Nutrition status at baseline

significantly influence the time to

healing. Patients with satisfactory/

poor nutritional status at baseline

took a mean of 20 days longer to heal

as compared to patient who had a

good nutritional status (P=0.01).

Patients who were confused/

disoriented healed after a median of

86 days (mean 139, SE 28.7).

Median time to reach 100% healing

for completely immobile patients was

86 days (M 124, SE 27.5) compared to

53 days (M 49, SE 6.5) for patient with

restricted mobility, the differences

was not statistically significant

(p=0.1).

The mean time to healing pressure

ulcers in patients 60 -69 years old was

34.9 days (SE 3.7). Patients< 60 years

of age healed after a mean of 56.4 (SE

6.6) and patients 70 to 79 and >= 80

years of age heal after 78.5 (SE 10.1)


42


Length of Follow-up

Results Limitations

and 67.1 days (SE 1.9) respectively.

These differences between age

groups were not significant.

The difference of the healing time

between different wound sizes was

not significant (P=0.07).

When baseline area was included in

calculating healing rates, a difference

in time to healing small versus large

wounds was observed, but the

variability of this difference was not

statistically significant.

In stepwise Cox proportional hazards

model only poor nutritional status at

the baseline was found to be

predictive at healing. Age, nutritional

status and % reduction in ulcer area

were all independently predictive of

time to healing after two weeks of

treatment.

Indirect Evidence Reference Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Bryant JL, Brooks TL,

Schmidt B, Mostow EN.

Reliability of wound

measuring techniques in

an outpatient wound

center. Ostomy Wound

Manage 2001;47(4):44-51.

Exploratory

descriptive study,

inter-rater reliability

study.

16 wound care

professional staff; 11

registered nurses and

five physicians.

Subjects were asked to

measure the wound area of

irregular shaped wounds

placed on a prosthetic leg.

Subjects measured asked to

measure the wound using 3

methods: there usual

method of practice,

clockwise method, and

perpendicular method.

The 3 methods were evaluated

against 2 criteria.1- against gold

standard where the 3

measurements compared (for their

accuracy) with computer assisted

measurement and the surface area

using special calculation. 2- Inter-

rater reliability.

The perpendicular method is

generally more accurate than the

other two when measuring across

verity of wound configuration.

However, a range of accuracy is

found for each other method

depending on the type of wound

leading to the conclusion that

different measurement methods are

better suited to different wound

shapes.

Used low technology

method to measure

wound, the study does

not represent true

random sampling, and

results may not be

generalized to all settings

or to full thickness

wounds. (P:50)

Bulstrode CJ, Goode AW,

Scott PJ. Measurement and

prediction of progress in

delayed wound healing. J R

Soc Med. 1987;80(4):210-

2.

Controlled

experimental study.

30 chronic leg ulcers

were available to

monitor there healing.

Healing was monitored

weekly using stereo-

photogrammetry from

admission into a controlled

trial to complete healing.

High-definition 3-

dimensional image of the

wound was photographed.

The surface of the skin and

Ulcers were monitored weekly till

healing occurred. Data were used to

define the characteristics in terms of

edge length and area of a healing

ulcer and to attempt to discover any

correlation with the time to

complete healing. The dimensions of

each week were averaged to

produce a standardized healing

3 phases for wound healing were

identified. First phase characterized

by actual increase in size, no change

or at the best only a slight decrease

in the size. The second phase was a

rapid healing. The third phase was a

progressively slower healing as the

size of the ulcer decreased to zero.

Percentage change in surface area

“It must be emphasized

that these predictive

values rely on the

availability of a very

accurate measurement

system.


43


Length of Follow-up

Results Limitations

the wound are scanned in a

fixed order, the computer

calculated the dimensions,

area and volume, of the

defect.

curve. Absolute changes in edge

length and surface area were

plotted week by week against time

to complete healing.

was found to provide better

prediction of the time to complete

healing than percentage change of

the edge length.

it was found that if the percentage

change in area in the third week was

multiplied by the factor 0.11 it would

have predicted the total time to

complete healing to within one week

in just under 50% of the ulcers.

Eager CA. Monitoring

wound healing in the

home health arena. Adv

Wound Care.

1997;10(5):54-7.

Descriptive study 145 completed surveys

were received from

enterostomal therapy

nurses at 500 home

agencies throughout

the United States.

A questionnaire was

developed using

recommendation on wound

assessment from the

Agency of Health Care

Policy and Research clinical

practice guideline on

pressure ulcer treatment.

The participants were

allowed to add additional

information, and were

asked to include a copy of

current wound

documentation form.

The documentation forms were

evaluated separately from the

questionnaires. And then a

comparison of questionnaire

responses and documentation data

was completed.

Pressure ulcer is the most commonly

treated (97%) type of wound in U.S

home health care agencies.

The average number of wounds seen

by an agency is 152/month.

The documentation forms used by

these agencies most commonly asked

clinician to document: date, site, or

location of the wound, size by length

and width, tissue type and color, the

surrounding skin description, type

and amount and of drainage, and

odor of the wound.

74% of respondents do wound

assessment at least weekly, 26% do it

less frequently or inconsistently.

54% of respondents monitor healing

by: change in length and width,

drainage, wound bed, wound edges,

pain, and odor.

90% of the agencies use the NPUAP

guidelines in their wound

assessment.

The comparison of questionnaire

responses and documentation data

revealed a general lack of universal

documentation standards, especially

in: documented medications, pain,

compliance, and peri-wound area.

The surveys were

received from

respondents representing

34 states.

Gethin G, Cowman S.

Wound measurement

comparing the use of

acetate tracings and

Visitrak digital planimetry.

J Clin Nurs.

Retrospective

comparative study.

25 acetate wound

tracings of superficial

lower limb wounds

which are < 10 cm2, and

25 acetate tracings of

superficial lower limb

(1) A clear two layered

acetate preprinted in 1 cm2

was placed over the wound

and the perimeter drawn

using fine tip permanent

acetate pen. The tracing

Both sets of wound measurements

were analyzed for differences in

area measurement.

The difference between area

measurements was not clinically

significant between the two

measures (t=0.995, d.f.= 24,

p=0.330). In the wound group<10

cm2, the mean wound measurement

Lack of sufficient tracing

after 4 weeks resulted in

inability to achieve the

second aim of the study.

The study cannot be

generalized to a wider


44


Length of Follow-up

Results Limitations

2006;15(4):422-7. wounds which are > 10

cm2.

date then identified. The

racing was later placed onto

the Visitrak™ unit and the

perimeter stylus so that the

underlying sensor could

calculate the area.

(2) The wound area was

calculated manually by

counting squares

completely within the

wound border and those

more than half full within

the border were counted as

1 cm2.

was 3.68 cm2 using acetate and 3.54

cm2 using Visitrak™. In the wounds

group .10 cm2, the mean wound

measurement using acetate was

24.96 and 24.31 cm2 using Visitrak™.

The difference between the methods

used to measure wound increased

with the size of the wound.

range of practitioners or

centers because the

study was conducted in

one center where a high

degree of skill is available

in wound measuring. The

study did not study cavity

wounds or wounds in

difficult areas, and the

depth gauge of the cavity

wounds was not

evaluated using the

Visitrak™.

Griffin JW, Tolley EA,

Tooms RE, Reyes RA, Clifft

JK. A comparison of

photographic and

transparency-based

methods for measuring

wound surface area. Phys

Ther. 1993;73(2):117-22.

Descriptive

correlational study.

20 inpatients (18 male,

2 female). A total of 22

ulcers were studied.

To assess test-retest

reliability of wound surface

area measurement, 5 ulcers

were assessed using both

photographic and

transparency methods, and

assessments were repeated

after one hour. To compare

the wound surface area

measurement obtained by

the photographic and

transparency methods, all

22 ulcers were measured on

a single occasion using each

method. To compare

photographic and

transparency wound surface

area measurement over

time, the 16 ulcer that were

available for longitudinal

study were measured at 5

day intervals for 20 days,

using each method.

(1)A high degree of intra-rater

reliability was demonstrated for

repeated measurement obtained

with both photographic and

transparency method. The

transparency and the photographic

methods provided equivalently

reliable wound measurement,

whether the mean of the three

measurements or single

measurements were used.

(2) Precision was slightly improvised

by using the average of three

measurements, particularly for the

photographic method. Time and

expenses involved in analyzing three

tracing versus a single tracing might

not be justified for such a small

increase in precision.

(3) Photographic and transparency

method wound surface area

measurements were significantly

correlated in the 22 ulcers (r=.99, p =

.001), and the tracings did not differ

significantly.

(4) Significant correlation between

methods was consistent, as healing

occurred in the 16 ulcers followed

over time. The two methods

continued to yield equivalent

measurements as ulcer became

The wounds in this study

were limited to pressure

ulcers in the pelvic region

of patients with spinal

cord injury, findings

might not be

representative of wounds

having different

etiologies or different

body locations.


45


Length of Follow-up

Results Limitations

smaller.

Haghpanah S, Bogie K,

Wang X, Banks PG, Ho CH.

Reliability of electronic

versus manual wound

measurement techniques.

Arch Phys Med Rehabil.

2006;87(10):1396-402.

Repeated measures. 4 trained blinded

observers, drawn from

the clinical and research

staff of the spinal cord

injury unit.

40 simulated wounds were

measured by each observer

using the 3 techniques. The

observers measured the

wounds in 2 separate

sessions with a minimum of

7 days between the sessions

to minimize memory effect.

Data were stratified and

analyzed for 2 large and

small wounds.

Inter-observer and intra-observer

variability.

For accuracy: the average root mean

square error (RMSE) for each

measurement technique was

determined.

For large wounds inter-observer

variation was significant for all

measurement techniques and intra-

observer variation was not significant

for any measurement technique.

For small wounds intra-observer

variation was not significant for linear

and Visitrak but was significant for

VeV, were inter-observer variation

showed the reveres result.

The linear measurement technique

the lowest accuracy for all

measurement techniques and all

observers; it showed very high RMSE

values for both large (mean =110)

and small wounds (mean = 29). For

large wounds Visitrak and VeV

showed the lowest RMSE values, with

VeV slightly better (mean= 22) than

Visitrak.(mean = 27). For small

wounds Visitrak and VeV showed the

lowest RMSE values, with Visitrak

even lower (mean = 3) than VeV

(mean = 5).

Use of simulated wounds,

in a highly controlled

conditions.

Hegarty C. VISITRAK. 2nd

World Union of Wound

Healing Societies' Meeting.

Paris, France 2004. p. 125.

Each assessor measured the

area of each of the 3

predefined templates; 5

times using VISITRAK digital

and 5 tomes using the

Counting Squares.

The areas measured and the time

taken to obtain the area

measurement was recorded.

There was a significant evidence

(P<0.001) than counting squares took

longer than VISITRAK Digital to

measure each of the template areas.

There was a significant evidence

(P<0.01) that the counting squares

method of the estimating the

template area was more variable

than VISITRAK Digital estimating the

template area was more variable

than VISITRAK Digital for each of the

templates.

Langemo DK, Melland H,

Hanson D, Olson B, Hunter

S, Henly SJ. Two-

dimensional wound

measurement: comparison

of 4 techniques. Adv

Wound

Comparative study. 66 raters,

representative of a

verity of skill levels in

wound measurement.

32 upper-division

undergraduate nursing

students, 27 staff

Three wound models were

used (Paris bases painted).

Each rater measured the

entire outer perimeter of

each of the 3 wounds using:

ruler length and width,

tracing on transparency,

The relative bias and standard error

of measurement for each technique,

for each wound shape was

calculated. The relative bias and

standard error of measurement was

obtained by taking the average of 2

measurements for each technique

1-The smallest relative bias was

associated with the SPG method. The

ruler length and width measurement

reflected the largest bias regardless

of wound shape.

2-The SPG area had the smallest SEM

for each wound shape. Both length

Use of wound models

rather than real wounds.


46


Length of Follow-up

Results Limitations

Care.1998;11(7):337-43. nurses and graduate

nursing students, 6

wound care nurses, and

1 whose status was not

revealed.

SPG length and width, and

SPG area.

by wound combination. Inter-rater

reliability was obtained by

measuring the intra-class

correlation. the interclass (Person)

correlation had been used to

evaluate the intra-rater reliability.

and width methods best measured

circular wounds, followed by the L-

shaped and the pear shaped wounds.

Tracing worked best for the pear-

shaped wounds, whereas SPG area

had the smallest SEM for the L-

shaped wound.

3-The inter-rater reliability of average

rating was high for all techniques.

The clinically relevant reliabilities for

single rating were low(.3-.53), except

for the SPG area technique (.87).

4-Intra-rater reliability was high for

the tracing method and low for the

SPg area method, with the two length

and width method between the

tracing and the SPG area methods.

The overall results of this study

indicate that: the computer (SPG)

area technique was found to be the

most accurate and least biased for

two-dimensional wound

measurement.

Majeske C. Reliability of

wound surface area

measurements. Phys Ther.

1992;72(2):138-41.

Descriptive

comparative study.

31 patients with

unhealed venous stasis

ulcer.

3 physical therapists made

two tracings of each wound

by tracing the wound

perimeter on a sterile

transparency with a marker.

The two tracings of each

wound were designated as

a pair of tracings. One

therapist traced 34 wounds

and the other two

therapists each traced 18

wounds. Each therapist

independently determined

the area of the tracing by

each of the following four

methods.

Inter-tester and intra-tester

reliability of four methods of

measuring wound area was

determined.

Mean wound areas from each

method were compared for

differences.

Intra-tester reliability for each

therapist using the 4 methods of

calculating wound area was high, all

correlation coefficient were .99.

Inter-tester reliability was high the

ICC value ranged from .97-.99.

Error from the

approximation of the true

wound area may had

been occurred due to

individual differences in

assessing wound’s

borders, or altered

wound size because of

the placement of the

transparency over the

wound..

Melhuish JM, Plassman P,

Harding KG.

Circumference, area and

volume of the healing

wound. J Wound Care.

1994;3(8):380-4.

Descriptive

comparative study.

14 patients were

studied. 7 patients had

healing pilonidal sinuses

and 7 patients had

abdominal wall cavity

wound arising from

The area, volume, and

depth of the wounds were

measured using a

structured light

measurement technique.

The software was modified

All wounds were measured weekly

in the clinical environment. Duration

of the study: 10 weeks. Comparison

between area, volume, and

circumference was done. Spearman

correlation coefficient used.

Results show that the circumference

of the wound is related to both the

volume and the area. There is a

stronger relationship between area

and circumference (0.95, P<0.001),

than volume and circumference


47


Length of Follow-up

Results Limitations

surgical procedures. to measure the 3-

dimensional circumference

of the wound.

(0.79. P = 0.001). comparing the

parameters during healing follow-up;

the volume, area, and circumference

measurement followed a similar

pattern in all the patients until

wound closer, with the correlation

between area and circumferences

was 0.94 (p<0.001), and the between

volume and circumference was 0.80

(p<0.01).

Ratliff CR, Rodeheaver GT.

Use of the PUSH tool to

measure venous ulcer

healing. Ostomy Wound

Manage. 2005;51(5):58.

Descriptive

exploratory study.

27 patients with venous

ulcer were followed.

The PUSH tool was used to

assess venous leg ulcers of

the sample group at each

visit to the clinic. Inter-rater

reliability for the tool was

established at the beginning

of the study. The trend of

the PUSH score was

compared to the individual

subject’s venous ulcer

healing trend to determine

whether the healing trend

was consistent over time.

The patients were followed

monthly for 2 months using the

PUSH tool at each visit

The mean scores of the PUSH were

different indicating a sensitivity to

change and scores were consistent

with outcome (P: 63). So in

conclusion the PUSH tool represents

an excellent starting point to validate

healing of venous ulcer (P: 64).

Small sample size.

Sugama J, Matsui Y,

Sanada H, Konya C, Okuwa

M, Kitagawa A. A study of

the efficiency and

convenience of an

advanced portable Wound

Measurement System

(VISITRAK). J Clin Nurs.

2007;16(7):1265-9.

Descriptive

correlational study.

To test the reliability:

10 inpatients, 7 females

and 3 males, with

pressure ulcer in a long-

term facility.

To test the validity: 30

inpatients with pressure

ulcers or develop

pressure ulcers during

the validity test period,

which is 6 months.

Inter-rater and intra-rater’s

reliability were established

by the 4 nurses traced the

wounds using the VISTRAK

wound measurement

system/ only one assessor

carried out the tracing, then

the traced wound areas

were redrawn three times

by each assessor onto the

digital pad using the

accessory pen in the

laboratory.

Concurrent validity was

assessed by comparing the

VISITRAK wound area

measurement with the

digital planimetry as a

standard. The wound area

in the digital planimetry

photographs were

measured 3 times each by

The outcome to assess reliability is

intra-class correlation coefficient.

The outcome to assess concurrent

validity: the coloration coefficient

between VISITRAK and digital

planimetry, which was calculated

from the average of three

measurements, which was similar to

the protocol of followed for the

reliability test.

Measurement outcome for the

convenience of the VISITRAK:

comparing duration of time of

measurement against that of the

digital planimetry.

The inter-rater and intra-rater

reliabilities for the VISITRAK were

excellent ( ICC= 0.99- o.75).

There was a significant strong

positive correlation between the two

wound measuring area

techniques(r=0.99, p,0.001).

The VISITRAK is significantly quicker

(median = 54 seconds) than the

digital planimetry (median = 126

seconds).

In conclusion: VISITRAK wound

measurement system is an efficient

wound measurement device.


48


Length of Follow-up

Results Limitations

each assessor with a digital

planimetry.

Convenience of the

VISITRAK was assessed by

recording the time it took to

calculate wound area in the

time taken to trace the

wound and measure the

area by VISITRAK

measurement system, and

the time required for

scanning and measurement

using the digital planimetry.

Taylor RJ. Mouseyes

revisited: upgrading a

computer program that

aids wound measurement.

J Wound Care.

2002;11(6):213-6.

Descriptive study Information was not

provided.

Two types of wound images

were entered to the

program: 1) securing a

wound tracing to the

computer screen and

recording the outline with

the mouse-controlled

graphics cursor, 2) working

with an image file derived

from a digital camera or

camcorder, saved onto

operation of the program.

Calibration and

measurement were done.

Each polygon’s outlines was

traced a total of 10 times

and the results entered into

SPSS for windows (release

10.0) spreadsheet. Group

means, standard deviations,

and coefficients of variation

(standard deviation divided

by the mean) were then

calculated. The significant of

difference between the true

and the measured result

was investigated using t-test

(p<0.05).

Comparing the levels of

reproducibility and agreement with

the true areas of the temple

measurement.

The program showed excellent levels

of reproducibility and agreement

with the true areas of the temples.

This version was less accurate in

tracing the wound than the previous

version, but exhibits a higher level of

reproducibility.

No information about the

number of images that

were used in this study.

Thawer HA, Houghton PE,

Woodbury MG, Keast D,

Campbell K. A comparison

of computer-assisted and

Inter-rater reliability

study.

45 out patients with

lower extremities

wounds of varied sizes,

and etiologies, and 38

The new technique is a

variation of the Stereo-

photogrammetry method of

wound measurement. The

1-The intra-rater and interrater

reliability of the new computerized

technique when assess surface area

of human wounds.

Both computerized and manual

techniques were reliable

measurement technique for assessing

the surface area of human and


49


Length of Follow-up

Results Limitations

manual wound size

measurement. Ostomy

Wound Manage.

2002;48(10):46-53.

CD-1 male mice chosen

on random bases.

new technique utilize single

digital camera and a

software, it provide serial

images for the wound and

determine both wound

dimensions and visual

characteristics.

2-Compare the inter-rater and intra-

rater reliability of the new technique

to reliability of well-established new

technique.

3-The reliability and validity of the

new technique in measuring small

wounds such as those found on

animals in laboratory experiments.

Evaluate the precision of each

technique when the average of 3

repeated measures of the surface

area are used compared with single

measurement of surface area.

animal wounds (P: 50). The

measurement of surface area

obtained by using the manual

technique was greater than those

obtained by computerized technique

(P: 50). Measuring smaller animal

wounds using the computerized

technique was more precise and

reliable than other techniques.

Taking the average of 3 repeated

measurements of surface area

resulted in:

Improvement in inter-rater reliability

of each measurement technique for

both human and animal wounds.

Improvement in the precision of

each technique with human wounds

Improvement in the precision of the

manual technique with the animal

wounds. (P: 50)

Thomas AC, Wysocki AB.

The healing wound: a

comparison of three

clinically useful methods of

measurement. Decubitus.

1990;3(1):18.

Cross-sectional

comparative study.

Total of 73 patients

with chronic wounds:

36 were with venous

stasis ulcers and 37 with

decubitus ulcers.

Wounds were measured

using each of the 3

methods; two

measurements for each

observation were made

using each device to ensure

reliability.

Comparing the measured areas of

actual healing wound using Pearson

correlation and repeated

measurement analysis of variance

(ANOVA) with follow-up

comparison.

Comparison of the three methods,

when data from both types of

wounds were combined, revealed

high correlation (r = .99). However,

the 3 methods were significantly

different from each other in terms of

measurements of actual wound

area.. The difference was remarkable

between Kundin method and other

two methods, it consistently

underestimate wound area,

especially in wounds of large area

and irregular shapes.


50

Table 3. Role of Nutrition in Pressure Ulcer Healing Direct Evidence Limitations Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results

Benati G, Delvecchio S,

Cilla D, Pedone V. Impact

on pressure ulcer healing

of an arginine-enriched

nutritional solution in

patients with severe

cognitive impairment. Arch

Gerontol Geriatr.

2001;7:43-7.

Evidence Level = III

Randomized, cohort,

clinical trial

Examined the effects

of high energy-

protein supplement

enriched with

arginine, zinc and

antioxidants on

pressure ulcer

healing in patients

with severe cognitive

impairment and

reduced oral food

intake.

n=36, inpatients with

cognitive impairments

and PrU

2 week intervention

Received oral nutritional

supplementation enriched

with protein (37 g/d) or

protein plus arginine (7.5

g/d), zinc (25 mg/d), and

antioxidant vitamins

A: Normal hospital diet

B: Hospital diet + High

protein calorie solution

C: Hospital Diet +ONS is

caloric, isonitrogenous

enriched in Arginine,

vitamins and trace elements

with antioxidant effects

PSST scores Group C: Pressure sore status tool

(PSST) scores for patients on the oral

supplementation exhibited rapid

improvement in pressure ulcer

healing, compared to patients on the

standard hospital diet with no

supplementation. Patients receiving

the protein + arginine + zinc +

antioxidant supplement had the

lowest PSST scores.

Sample size

No statistical analysis

Bourdel-Marchasson I,

Barateau M, Rondeau V,

Dequae-Merchadou L,

Salles-Montaudon N,

Emeriau JP, et al. A multi-

center trial of the effects

of oral nutritional

supplementation in

critically ill older

inpatients. GAGE Group.

Groupe Aquitain

Geriatrique d'Evaluation.

Nutrition. 2000;16(1):1-5.

Evidence Level = I

Multicenter,

randomized clinical

trial

Effect of nutritional

supplementation on

dietary intake and on

PrU development in

critically ill older

patients

19 wards stratified: 9

wards randomly

selected for ONS

intervention

n=672; 377 in control;

295 in ONS

>60% female; Age =83.3

years; BW=55.2-60.2 kg

Control group at higher

risk of PrU per Norton

and Kuntzmann score

ONS group at higher

risk of PrU per serum

albumin levels

Control: Standard diet, 1800

cal/day

Nutrition Intervention for

15 days: 2 ONS/day, each

providing 200 kcal, 30%

protein, 20% fat, 50%

carbohydrate, 1.8 mg zinc,

15 mg vitamin C

(Jacquemaire-Sante;

Nutricia; Clintec-Sopharga)

PrU grades (AHCPR)

PrU incidence

Nutritional intake

Higher energy and protein intake on

ONS group (1081 kcal vs. 957 kcal,

p<0.006; 45.9 g protein vs. 38.3 g

protein, p<0.001)

PrU cumulative incidence:

Day 5: 16% ONS vs. 25% control

Day 10: 27% ONS vs. 37% control

End of follow-up: 40% ONS vs. 48%

control

Hypoalbuminemia, lower limb

fracture, Norton score <10 vs. >14,

high Kuntzman score, belonging to

control group were independent risk

factors for PrU development

Belonging to the ONS group was a

protective factor

Randomization by center

not individual

Different baseline risks of

study groups

No information on other

medical interventions

Desneves KJ, Todorovic BE,

Cassar A, Crowe TC.

Treatment with

supplementary arginine,

vitamin C and zinc in

patients with pressure

ulcers: a randomized

controlled trial. Clin Nutr

2005; 24:979-987.

Randomized clinical

trial

Determine

nutritional status of

patients dx with pre-

existing PrU &

determine whether

nutrients putatively

implicated in PrU

n=16

Age: 37-92 years; BMI =

16.4-28.1

Stage 2, 3, 4 PrU

3 week intervention

A: Standard hospital diet

B: Standard diet + 2 high-

protein/energy ONS (500

kcal, 18 g protein, 72 mg

vitamin C, 7.5 mg zinc;

Resource Fruit Beverage,

Novartis)

C: Standard diet + 2 high-

protein/energy

Body weight

Blood biochemistry

Pressure ulcer severity: PUSH scores

Food and fluid intake

At baseline all patients had low levels

of serum albumin & zinc and elevated

CRP; normal transthyretin levels

After 3 weeks:

94% compliance with ONS

No significant changes in oral dietary

intake, body weight & biochemical

markers

Trend in body weight increase (1.2,

0.4, 1.1 kg in diets A, B, C, resp)

Sample size


51

Limitations Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results

Evidence Level = II

healing (arginine,

vitamin C, zinc) will

improve rate of PrU

healing

supplements (500 kcal, 21 g

protein, 9 g additional

arginine, 500 mg vitamin C,

50 mg zinc; Resource

Arginaid Extra, Novartis)

Significant (p<0.05) improvements in

SH scores in Diet C compared to

baseline (9.4 vs. 4.4 at week 2, 2.6 at

week 3)

Significantly (p<0.05) lower PUSH

scores at week 3 in Diet C (2.6) vs.

Diets A (7.0) & B (6.0)

Diet A: significant (p<0.05)

improvements in PrU healing

Diet C: 2.5 fold greater improvement

in pressure ulcer healing after 3

weeks compared to other 2 diet

groups

No differences in energy & protein

intakes across groups

Significantly (p<0.05) higher intakes

of arginine, vitamin C, zinc in Diet C

Frias Soriano L, Lage

Vázquez MA, Maristany

CP, Xandri Graupera JM,

Wouters-Wesseling W,

Wagenaar L. The

effectiveness of oral

nutritional

supplementation in the

healing of pressure ulcers.

J Wound Care.

2004;13(8):319-22.

Evidence Level = V

Open Intervention

Study Multicenter,

open intervention,

non-placebo

controlled clinical

study

Effectiveness of oral

nutritional

supplement that is

rich in protein,

enriched in arginine,

vitamin C, and zinc,

on healing of

pressure ulcers

n=63 included in study

but n=39 completed

Mean age = 74 y, 54%

female, 46% male, BMI

= 22.9, 24% were

nutritionally depleted

Grade III or IV PrU

Oral nutrition supplement

daily for 3 weeks

Cubitan (Nutricia) per 200

mL provided: 250 kcal, 20 g

protein (3 g arginine), 28.4 g

carbohydrate, 7 g fat, 250

mg vitamin C, 37.6 mg α-TE,

9 mg zinc; all other

micronutrients present at 8-

150% of US RDA for >50

years of age

Weekly assessment of:

Nutritional intake

Wound area

Wound condition

Anthropometric data collected at

baseline and week 3

After 3 Weeks:

Significant reductions (29%) in wound

area from 23.6 cm2 to 19.2 cm2

(p<0.001)

Median healing of 0.34 cm2 per day

Trend in reduction of amount of

exudates in infected ulcers (p=0.012)

Significant reduction in incidence of

necrotic tissue (p=0.001)

No significant change in body weight,

BMI

ONS consumption = 1.9 packs/day

37% perceived adequate oral intake,

29% took 75-100%, 34% took 50-75%

of required energy intakes

No effect of intervention, i.e.

improvements in nutritional status of

depleted patients

Open study design, no

blinding of investigators

Completers only analysis

Drop-out rate (38%)

Healing rates compared

to historical controls

No information on total

nutrient intake, medical

status, medical

interventions

Guenter P, Malyszek R,

Bliss DZ, Steffe T, O'Hara D,

LaVan F, et al. Survey of

nutritional status in newly

hospitalized patients with

stage III or stage IV

pressure ulcers. Adv Skin

Wound Care. 2000;13(4 Pt

1):164-8.

Descriptive

Study(Prospective

and Retrospective)

Examine the

nutritional status of

newly hospitalized

patients with Stage

III or Stage IV PrU

n=120 non-ICU patients

with Stage III or IV PrU

No intervention Body weight

Blood biochemistry

Nutritional intake

Type of PrU

Majority of patients were elderly

(58%), & females (53%). Stage III

sacral ulcers most common (74.2%).

Most patients were below UBW, had

low serum prealbumin and albumin

levels (88% and 92%). 75% of patients

had moderately low or severely low

serum prealbumin levels. 59% of

patients had low or severely low

serum albumin levels. Nutritional

Descriptive study; Limited

information on nutrient

intake


52


Length of Follow-up

Results

Evidence Level = V

intakes were inadequate to meet

needs of patients, met 55% of needs

Horn SD, Bender SA,

Ferguson ML, Smout RJ,

Bergstrom N, Taler G, et al.

The National Pressure

Ulcer Long-Term Care

Study: pressure ulcer

development in long-term

care residents. J Am

Geriatr Soc.

2004;52(3):359-67.

Evidence Level = V

Also in Table on

Assessment

Retrospective, cohort

study

Identify resident,

treatment, facility

characteristics

associated with PrU

development in long-

term care residents

95 LTC in US

1524 residents, >18 y,

>14 d LOS, at risk of

developing PrU, Braden

Score <17 on entry

No intervention Over 12 weeks:

Resident characteristics

Treatment characteristics

Staffing ratios

Facility characteristics

PrU development during study

During 12-week period:

71% did not develop PrU

29% developed PrU

Characteristics associated with

development of PrU: higher initial

severity of illness, history of recent

PrU, significant weight loss, oral

eating problems, use of catheters,

use of positioning devices.

Characteristics associated with

decreased likelihood of PrU: new

resident, use of ONS, tube feeding for

>21 days, antidepressant use, use of

disposable briefs, RN hours of 0.25

hours/resident/day, LPN turnover

<25%

Convenience sample

No data on type of

nutritional interventions

and its impact on PrU

Houwing RH, Rozendaal M,

Wouters-Wesseling W,

Beulens JWJ, Buskens E,

Haalboom JR. A

randomised, double-blind

assessment of the effect of

nutritional

supplementation on the

prevention of pressure

ulcers in hip-fracture

patients. Clin Nutr.

2003;22(4):401-5.

Evidence Level = II

Double-blind,

randomized,

placebo-controlled

clinical trial

Effect of nutritional

supplementation on

incidence of PrU in

hip-fracture patients

at risk of developing

PrU

n=103; placebo=52;

ONS=51

Age: 81 years; BMI=24

28-day intervention or until

discharge

Supplementation started

after surgery

Placebo: water-based, non-

caloric ONS

ONS: 400 ml/d; 40 g

protein, 6 g arginine, 20 mg

zinc, 500 mg vitamin C, 200

mg α-TE, 4 mg carotenoids

Presence and stage of PrU (EPUAP) 70% of patients consumed ONS for 1

week or more

75% of patients consumed 75% or

more of daily dose

57% of all patients developed PrU,

23% developed Stage 2 PrU

Incidence of PrU was not different

between placebo (59%) vs. ONS

(55%)

Incidence of Stage 2 PrU was lower

(9%) in ONS (19%) vs. placebo (28%)

Trend (p=0.09)towards later onset of

PrU in ONS group (3.6 days) vs.

placebo (1.6 days)

Number of days of prevalent PrU

lower in ONS vs. Placebo group (4.4

vs. 5.0 d)

Power and sample size

No information on

nutrient intake & other

medical interventions

Langer G, Schloemer G,

Knerr A, Kuss O, Behrens J.

Nutritional interventions

for preventing and treating

pressure ulcers. Cochrane

Database Syst Rev.2003;(4)

CD003216.

Systematic review

Evaluate

effectiveness of

enteral and

parenteral nutrition

on the prevention

and treatment of

Published randomized

controlled trials

Enteral and parenteral

nutrition support

Incidence of new PrU

Ulcer healing or changes in PrU

severity

8 RCT trials out of 16 potentially

relevant studies were included

4 studies evaluated effects of

nutritional supplements for

treatment of existing PrU: 1 with

mixed nutritional supplements, 1

with zinc; 1 with protein; 2 with

ascorbic acid

Small studies

Methodological issues


53


Length of Follow-up

Results

pressure ulcers Not possible to draw a firm

conclusion on the effect of enteral

and parenteral nutrition on the

prevention and treatment of PrU

Dietary supplementation may

prevent PrU in acutely ill older

people, more research is needed to

identify effective dietary

interventions

Langkamp-Henken B,

Herrlinger Garcia KA,

Stechmiller JK, Nickerson

Troy JA, Lewis B, Moffatt L.

Arginine supplementation

is well tolerated but does

not enhance mitogen-

induced lymphocyte

proliferation in elderly

nursing home residents

with pressure ulcers. JPEN

J Parenter Enteral Nutr.

2000;24(5):280-

Evidence Level = II

Randomized clinical

trial

Determine level of

arginine

supplementation

that is orally and

metabolically

tolerated and

effective in

enhancing immune

function in elderly

patients with PrU

0 g Arg: n=10, 82 y

8.5 g Arg: n=11; 81 y

17 g Arg: n=11; 87 y

2 LCTs

4 weeks of supplementation

Arginine supplementation: 0

g, 8.5 g, 17 g

Nutritional status & intake

Oral tolerance: nausea, vomiting,

abdominal distention, diarrhea

Metabolic tolerance: serum

electrolytes

Immune function: IL2 production;

Lymphocyte proliferation

%IBW, serum albumin levels did not

change over the 4-week

supplementation period

Total energy and protein intake and

% weight change were not different

among Arg supplementation groups

Significant increase in plasma

Arginine with supplementation

Good oral and metabolic tolerance

Arginine supplementation did not

enhance proliferative responses

4 weeks of Arginine supplementation

resulted in significant (p<0.05)

decrease in lymphocyte proliferation

in supplement groups 17 g vs. 8.5 g

No report of PrU healing

rates

Lee SK, Posthauer ME,

Dorner B, Redovian V,

Maloney MJ. Pressure

ulcer healing with a

concentrated, fortified,

collagen protein

hydrolysate supplement: a

randomized controlled

trial. Adv Skin Wound Care.

2006;19(2):92-6.

Evidence Level = II

Randomized,

prospective, double-

blind, placebo-

controlled

multicenter trial

Compared PrUs

scores at 8 weeks in

long-term care

residents with PrU

given standard care

plus a concentrated,

fortified, collagen

protein hydrolysate

supplement vs.

residents given

standard care plus

placebo

23 long-term-care

facilities in 4 states

n=89; 71 completed

study

n=56 intervention; n=33

placebo

Stage 2, 3, 4 PrU

8 week intervention

Standard care plus

concentrated, fortified,

collagen protein hydrolysate

(15 g in 45 mL unit dose,

ProStat, Medical Nutrition

USA) vs. placebo

Wound healing: PUSH scores

Frequency of PrU stage by group

Supplement intake

75 PrU in intervention & 33 in control

group

After 8 weeks:

PUSH scores decreased for all

patients; twice rate of healing in

intervention group vs. control

Significantly better PUSH scores in

intervention group vs. placebo (3.55

vs. 3.22, p<0.05)

Randomization process;

group differences at

baseline

Data variability & analysis

Convenience sample

No information on

patient medical status,

nutrient & other medical

intervention data

Raffoul W, Far MS, Cayeux

M-C, Berger MM.

Nutritional status and food

Prospective, non-

comparative,

observational, cohort

n=9

Age=71 y; BMI=23.3

Started 5 days prior to sx

until 10 days after sx

Encouraging oral food

BMI, food intake, blood chemistries Anemia and inflammation in 4

patients

Highly variable food intake, meeting

Study design


54


Length of Follow-up

Results

intake in nine patients with

chronic low-limb ulcers

and pressure ulcers:

importance of oral

supplements. Nutrition.

2006;22(1):82-8.

Evidence Level = V

study

Investigate the

micronutrient status,

food intake and role

of ONS in elderly

patients with chronic

low-limb ulcers and

PrU

Identify nutritional

risk factors of

delayed wound

healing

intake; standardized diet

(300 kcal at breakfast, 700

kcal at lunch, 700 kcal at

dinner)

1-4 units of ONS/d provided

(each unit providing 300

kcal, 11.2 g protein,

predominantly Clinutren,

Nestle)

One multivitamin tablet/day

500 mg vitamin C/d

31-95% of energy intake

ONS were willingly consumed (2.4

units/d), meeting 35% of energy &

40% of protein requirements

Selenium & zinc requirements were

not met

Complete wound healing achieved in

all cases; 7 of 9 having straight

healing

Reddy M, Gill SS, Rochon

PA. Preventing pressure

ulcers: a systematic

review. JAMA. 2006;

296:974-84.

Evidence Level = I

Systematic review

Systematically review

the evidence

examining

interventions to

prevent PrU

5 RCTs targeted

impaired nutrition

interventions

1475 patients: 66% in

acute care, 34% in LTC

varied PrU prevention In patients with nutritional

impairments, dietary supplements

may be beneficial

Study designs,

randomization, blinding,

interventions

Spungen AM, Koehler KM,

Modeste-Duncan R, Rasul

M, Cytryn AS, Bauman WA.

9 clinical cases of

nonhealing pressure ulcers

in patients with spinal cord

injury treated with an

anabolic agent: a

therapeutic trial. Adv Skin

Wound Care.

2001;14(3):139-44.

Evidence Level = V

Case studies

Examined effect of

oxandrolone and

glutamine of PrU

healing in spinal cord

injury patients with

PrU

n=9; Spinal cord injury

patients with non-

healing pressure ulcers

or full-thickness

pressure ulcer

Patients treated with

oxandrolone (20 mg/d) and

glutamine (20 g/d) from 1 to

12 months

Wound healing 89% of patients had completely

healed wounds within 3 to 12 months

Study design

Sample size

Stechmiller JK, Langkamp-

Henken B, Childress B,

Herrlinger-Garcia KA,

Hudgens J, Tian L, Percival

SS, Steely R. Arginine

supplementation does not

enhance serum nitric oxide

levels in elderly nursing

home residents with

pressure ulcers. Biol Res

Nurs. 2005; 6:289-99.

Randomized clinical

trial

Determine if arginine

supplementation

enhances in vitro and

in vivo measures of

immune function in

nursing home elderly

with PrU

n=26; >65 years, with

PrU

4 week Arginine

supplementation

8.5 g L-Arginine

Isonitrogenous supplement

(22.4 g Promod containing

0.4 g arginine)

3 servings/d of 50 mL each

10 week follow-up

Immune function measures:

Neutrophil burst, mitogen-induced

lymphocyte proliferation, DTH, NO

Serum amino acid levels

Good compliance and tolerance of

supplements

Trend in rising serum Arg levels; by

week 10 significant. decline observed

in serum Arg level in Arg-supplement

group

Significant increase in serum

ornithine (p<0.01) in Arg-suppl group

No significant difference in

lymphocyte proliferation in both

groups at week 4 vs. baseline;

significant difference between suppl

No information on PrU

healing, incidence


55


Length of Follow-up

Results

Evidence Level = II

groups at week 10 vs. week 4 &

baseline; Arg-suppl group maintained

while isonitrogenous group

decreased lymphocyte proliferation

response

No significant change in NO between

or within group

No significant diff in BMI. body

weight, prealbumin, MNA between

groups at weeks 4 and 10

Stratton RJ, Ek A-C, Engfer

M, Moore Z, Rigby P,

Wolfe R, Elia M. Enteral

nutritional support in

prevention and treatment

of pressure ulcers: A

systematic review and

meta-analysis. Ageing Res

Rev. 2005; 4:422-50.

Evidence Level = I

Systematic review,

Meta-analysis

Determine effect of

enteral nutritional

support on PrU

incidence, healing

QOL, complications,

mortality, nutritional

status

36 studies met inclusion

criteria. 15 RCTs

included in systematic

review. 5 RCTS

comparing ONS and

enteral tube feeding

included in meta-

analysis

ONSTube Feeding PrU incidence

Healing

QOL

Complications

Mortality

Dietary intake

Nutritional status

ONS (200-500 kcal, high protein,

consumed for 2 to 26 weeks)

associated with significantly lower

incidence (25% lower) of PrU in at

risk patients vs. routine care. Meta-

analysis of all 5 RCTs showed

significantly lower incidence of PrU

development in at-risk patients vs.

routine care. Compared to standard

formulas, disease specific products

(high-protein) use exhibited trend

towards improved healing of existing

PrU.

Quality of evidence is

"poor", need additional

research to substantiate

findings


Length of Follow-up

Results Limitations

de Luis DA, Izaola O,

Cuellar L, Terroba MC,

Aller R. Randomized

clinical trial with an enteral

arginine-enhanced formula

in early postsurgical head

and neck cancer patients.

Eur J Clin Nutr.

2004;58(11):1505-8.

Randomized clinical

trial

Investigate whether

postoperative

nutrition of head and

neck cancer patients

using an arginine-

enhanced formula

could improve

nutritional variables

as well as clinical

outcomes

90 patients with oral

and laryngeal cancer

At surgery, patients were

randomly allocated to two

groups:

Group I: patients receiving

an arginine-enhanced

formula with arginine and

fiber (IMPACT, Novartis)

Group II: patients receiving

an isocaloric, isonitrogenous

formula with fiber enteral

formula (Isosource,

Novartis)

Wound healing

Nutritional status

Infection

LOS

No significant intergroup differences

in the trend of the three plasma

proteins (albumin, transferrin,

prealbumin) and lymphocytes

GI tolerance (diarrhea) was better in

group II than I (40% group I and 13%

group II: P<0.05)

Postop complications due to

infections were similar in both groups

(4% group I and 9% group II: ns).

Fistula (wound complication) was less

frequent in the enriched nutrition

group (5% group I and 11% group II:

P<0.05).

Wound infection was similar in both

groups.

Not PrU


56


Length of Follow-up

Results Limitations

Length of postoperative stay was

better in group I than II.

Pompeo M.

Misconceptions about

protein requirements for

wound healing: results of a

prospective study. Ostomy

Wound Manage.

2007;53(8):30

Prospective,

descriptive study

Evaluate the

hypothesis that

wound patients

require higher levels

of protein than is

commonly

recommended & that

wound size and

severity affect

protein requirements

Tube fed patients with

& without wounds in 1

LTC (author's facility)

Wound group, n=93;

72.5 y; 60% female

Non-wound group,

n=57; 70.3 y; 54%

female

Wound group: 1.25 g

protein/kg/d

Non-wound group: 1 g

protein/kg/d

PUSH score

Protein status

47% of wound group vs. 32% in non-

wound group had diabetes.

12% of wound group vs. 21% non-

wound group had normal PreAlb

levels at admission.

LOS was longer for wound group vs.

non-wound group (36.9 vs. 29.7

days).

42% of wound group & 46% of non-

wound group normalized &/or

increased PreAlb levels.

Feeding failure more common in

wound group

Patients improving protein status

received significantly (p=0.001)

higher dietary protein: 1.85 g/kg/d in

wound group & 1.47 g/kg/d in non-

wound group.

Lower PUSH and total surface area on

admission seen in wound group that

did not improve protein status

Trend between higher wound burden

and max amount of protein provided

seen in patients whose PreAlb

improved.

Descriptive study;

sampling

Limited information on

tube feed protocol


57

Table 4. Pain Assessment and Management Direct Evidence


Length of Follow-up

Results Limitations

Abbas SQ. Diamorphine-

Intrasite dressings for painful

pressure ulcers. J Pain

Symptom Manage.

2004;28(6):532-4.


Also in Table 15 Palliative

Care

Retrospective

study

N=17, (9 females, 8

males)

Inclusion: diagnosis of

incurable malignancy,

Grade 2+ pressure ulcers

Mean age 68 years

(range 47-89 years).

Dressings applied with diamorphine

5-10 mg & Intrasite on a 4 X 4

dressing. Dressing changed every 12-

24 hours.

Patients routinely recorded the

severity of their pain on a visual

analogue scale (VAS) ranging from 0

to 10 (0 = asymptomatic) on

admission and after 5 days. Clinical

details were recorded from their

notes. Data collected over 30

months.

2 patients died as a result

of progressive illness

within a week after

application. The

remaining 15 patients

showed an improvement

on VAS: 12/17 (70.5%)

improved by 4+ points.

Mean VAS improved from

9.4 to 4.6 after the

treatment (P = <0.02).

Conclusion: diamorphine-

Intrasite gel may be an

effective treatment for

open pressure ulcers in

palliative care setting and

general medicine units.

More research needs to

be done to address the

possibility of long-term

tolerance, intact skin

pain response, and the

right dose and type of

topical opioids.

Dallam L, Smyth C, Jackson

BS, Krinsky R, O'Dell C,

Rooney J, et al. Pressure ulcer

pain: assessment and

quantification... including

commentary by Gray M with

author response. J Wound

Ostomy Continence Nurs.

1995;22(5):211-8.


Prospective cross-

sectional study.

N=132 adults in tertiary

med center

Inclusion:

-1 or > Stage I-IV PrU,

Other:

78 (59%) female, 54

(41%) male, average age

71.4 (24-100).

68.9% had a sacral PrU

Group 1: n=44, Respondents, 1

interview

Group II: n=88, Nonrespondents

1 year data collection period, data

collected at 3 month intervals, charts

reviewed by researchers

Folstein Mini-Mental Status Exam,

Beck’s Depression Inventory, Faces

Pain Rating Scale, Visual Analog

Scale + chart review. Tools have

previously been reported to have

good reliability & validity.

Pain: “unpleasant sensory &

emotional experience with actual or

potential tissue damage.”

Data collected at 3 month intervals,

but most only 1 time total.

Respondents: 41% denied

PrU pain & 68% reported

some degree of pain.

Most PrU were on sacrum

(70%), buttocks (24%) &

heels (14.4%).

Only 3 of 132 had received

analgesia for PrU pain in

preceding 4 hours, yet

many others had received

other types of pain meds

not for PrU pain.

Max pain score

significantly & inversely

correlated with age (r=-

.36, p<.02) & positively

correlated with max pain

intensity assessed by FRS

(r=.92, p<.01). Intensity of

pain localized to PrU sites

Non-respondent group

would have limited

ability to participate.

Primary conclusions can

be applied to

respondent group

rather than non-

respondent group.


58


Length of Follow-up

Results Limitations

significantly correlated

with generalized pain

intensity on VAS (r=.59,

p<.1) & generalized pain

intensity assessed by FRS

(r=.53, p<.1). Localized

VAS significantly

correlated with max PrU

stage (r=0.37, p<.01).

Those receiving analgesics

for PrU pain reported

significantly greater than

those not receiving

analgesics (p<0.05) &

those receiving narcotics

reported significantly

greater pain than those

not receiving narcotics

(.02). Patients with PrU

experience pain, & many

perceive it as severe, &

most did not receive

analgesics for PrU pain.

Stage IV PrU subjects had

greater pain than those

with lower stage PrU. Was

high degree of agreement

between FRS and VAS.

de Laat EHEW, Scholte op

Reimer WJ, van Achterberg T.

Pressure ulcers: diagnostics

and interventions aimed at

wound-related complaints: a

review of the literature. J Clin

Nurs. 2005;14(4):464-72.

Systematic review

Systematic Review 13 publications r/t pain &

PrUs

Inclusion:

to ID state of the art on

pain, wound malodor or

exudates in pressure

ulcer patients

Aim: To describe the current scientific

evidence in the field of diagnostics

and treatment of pain, wound

malodor and exudate from pressure

ulcers and to give recommendations

for practice, based on the findings.

Methodological Quality: Literature

searched systematically for current

state of knowledge on the diagnosis

of pain, wound malodor and

exudates in patients with PrUs and

interventions used to treat these

problems. The first author screened

abstracts of all publications on the

basis of inclusion and exclusion

criteria. If any doubts, the whole

article was retrieved. If doubts

remained on the basis of the whole

article, another author was

consulted to decide about inclusion

or exclusion.

McGill Pain Questionnaire (MPQ):

Is strong evidence to

support a positive effect

of topical (dia)morphine

for painful PrUs. Is some

evidence to support

positive effect of

benzydamine gel and

Eutectic Mixture of Local

Anaesthetic (EMLA)

cream. The reviewers

recommend to consider

both benzydamine gel and

EMLA as specific relieving

interventions in patients

with severe pressure

related pain, e.g., in

preparation of wound

Although pressure ulcer

prevention and wound

treatment are well

researched, little

evidence could be

retrieved with regard to

common symptoms

related to pressure

ulcers. Further research

should be conducted

into: psychometric

qualities of MPQ, VAS

and FRS in pressure

ulcer patients; methods

to operationalize the

diagnosis of wound

malodor; the effect of


59


Length of Follow-up

Results Limitations

This tool provides a description of

the qualities of pain, as well as

measurement of pain intensity. The

validity and reliability of the MPQ

have not been tested specifically in

pressure ulcer patients. However, a

great deal is known from other

more general pain literature.

Visual Analogue Scale (VAS): Proved

to be very suitable to measure pain

intensity and was also used to

measure pain in pressure ulcer

patients.

Faces Rating Scale (FRS): This tool

correspond well with the VAS in

patients with pressure ulcer pain.

The VAS strongly correlated with the

FRS (r=0.92; P < 0.01).

Pressure Sore Status Tool (PSST). It

consists of 13 Likert scaled item and

is used to describe the state of a

pressure ulcer. The interrater and

intra-rater reliability of the total

scale are high in Enterostomal

Therapy Nurses (r > 0.90; P < 0.01).

Face validity of the PSST has been

proven by experts.

debridement. From the

results on malodor and

exudates, the reviewers

cannot recommend a

specific dressing. In a

laboratory study, it is

proved that activated

charcoal is capable of

absorbing gas molecules

causing malodor. At

present, no studies are

available on the odor-

absorbing capacity of

activated charcoal

dressing in PrU patients.

Exudate is a symptom of

impaired wound healing.

PSST is a valid and reliable

instrument for assessing

wound healing process. Is

a possible indication that

hydrocolloid positively

influences healing time

because the absorption of

exudates is more

effective.

The McGill PQ, VAS, and

FRS useful to assess PrU

pain.

Conclusion: Little sound

research has been done

on wound related

complaints IN PrU pts.

Authors recommend:

-using the MPQ, VAS or

FRS to diagnose PrU pain;

-using PSST for good

wound assessment/

evaluation; -using

(dia)morphine gel,

benzydamine-gel or EMLA

for pain relief;

-using hydrocolloid

dressing in exudating

topical analgesia (EMLA)

or benzydamines in

treatment of pressure

ulcer pain; the effect of

activated charcoal

dressing on pressure

ulcer malodor; the

effects of various types

of dressing on pressure

ulcer exudates and

alternative

interventions to

decrease pain; exudates

and wound malodor in

pressure ulcer patients.

Recommend using

MPQ, VAS & FRS to

diagnose PrU pain, using

MS gel, benzydamine

gel or EMLA for pain

relief.


60


Length of Follow-up

Results Limitations

wounds.

Flock P. Pilot study to

determine the effectiveness

of diamorphine gel to control

pressure ulcer pain. J Pain

Symptom Manage.

2003;25(6):547-54.

Evidence Level = II


Care

Randomized,

double-blind,

placebo-

controlled

crossover pilot

trial. Patients

served as own

controls.

N=13 patients from

inpatient hospice unit

admitted over 7 months

(mean age 77 years, 10

females).

N=7 who completed

study.

Inclusion: Grade II or III

painful PrU, inpatient for

1 or > weeks.

Exclusion: Grade I or IV

PrU, non-PrU. 12 on

sacral area, 1 heel, 62%

Stage II, mean size 9cm2.

Random assignment to 1 of 2

treatment sequences: 3 days of

IntraSite gel followed by 3 days of

diamorphine gel, or vice versa.

IntraSite gel is ready-mixed HDG &

used as placebo. Diamorphine gel

(0.1% weight to weight mixture) was

mixed with IntraSite gel. Gels applied

1x/day & covered with standard

dressing. All patients had pressure

relieving cushions & mattresses &

encouraged to change positions

frequently. Pre-trial, PrU location, size

& stage were documented.

Prior to study entry PrU size,

location, stage was recorded. Pain

assessed before, 1, & 12 hours after

gel application by nursing staff

blinded to treatment sequence.

Patients rated pain as none, mild,

moderate, or overwhelming & this

translated to scores of 0=no pain to

4=overwhelming. Nurses checked

1x/day for skin irritation, pruritus,

constipation, nausea and/or

vomiting, drowsiness,

hallucinations, myoclonus jerking,

respiratory rate. Follow-up was 3

and 6 days.

Seven patients completed

study (5 died, 1 became

confused). Pain scores

similar before IntraSite &

diamorphine gel

applications. Pain scores

improved significantly 1

(p=0.003) and 12 hours

(p=0.005) after

diamorphine gel

application compared with

placebo/baseline. Four

patients were pain- free

after 1 hour & 3 after 12

hours. No significant

difference in occurrence

of side effects between

groups at 1 or 12 hours.

No difference in systemic

pain med in the 2 groups.

Symptoms of opioid

toxicity similar in both

groups.

Side effects not studied.

Small sample size (but

pilot study). High

attrition rate.

Franks PJ Winterberg H,

Moffatt CJ. (2002). Health-

related quality of life and

pressure ulceration

assessment inpatients treated

in the community. Wound

Rep Regen. 10:133-40.

Case control study

design randomly

selected from

patients receiving

home care,

stratified by the

presence of a

pressure ulcer.

Patients were

interviewed.

N=175; 100 controls

without pressure ulcers;

75 patients with pressure

ulcers. Persons with

pressure ulcers were 55

women (73%), mean age

77.3 (16.1) years.

Pressure ulcer grades: 19

grade 1; 32 grade 2; 20

grade 3; 3 grade 4.

Pressure ulcer sites: 55%

sacrum; 35% heels; 13%

hips.

To determine the impact of pressure

ulcers on health related quality of life

for patients living in the community

Short Form-36 (SF-36) and the

modified Barthel scale for

assessment of activities of daily

living. The SF-36 includes a bodily

pain score.

Bodily pain scores were

poorer for patients

without pressure ulcers

versus patients with

pressure ulcers when

controlling for age and

gender. Patients with

pressure ulcers had

significantly reduced self-

care and mobility and

poorer performance of

activities. Although there

were differences in the

two groups, the persons

with pressure ulcers were

similar to other patients

receiving community

nursing care. Many

patients with pressure

ulcers were not able to


61


Length of Follow-up

Results Limitations

give informed consent and

some were not able to

complete the SF-36.

Freeman K, Smyth C, Dallam

L, Jackson B. Pain

measurement scales: a

comparison of the visual

analogue and faces rating

scales in measuring pressure

ulcer pain. J Wound Ostomy

Continence Nurs.

2001;28(6):290-6.

Evidence Level = V

Secondary data

analyses as part of

a cross-sectional

study (reanalysis

of Dallam et al.

study)

N=44 respondents, N=88

non-respondents.

Inclusion:

-18 years or older,

-one or more stage I to IV

pressure ulcers, -some

ability to communicate

their pain experience.

Pain measured when no treatment

being performed, including dressing

changes. Researcher either described

the location of the PrU or pointed to

the area of PrU & asked subject to

mark on VAS scale the amount of pain

felt or perceived at the PrU site. In

case subjects couldn’t comply with

VAS instructions, each subject then

shown FRS and told to mark the face

reflecting degree of pain felt at PrU

site.

The scatter-plot illustrated the

relationship between the FRS and

VAS did not appear to be linear.

Thus, nonlinear least squares

regression approach used with a

Gauss-Newton iterative procedure.

FRS used as independent variable

and VAS as a dependent variable.

Visual Analogue Scale (VAS) used

was a 0 to 100 mm horizontal line.

The Face Rating Scale (FRS) used

was 6 faces ordered horizontally

from smiling to crying, labeled 0 to 5

beneath each face, respectively

The study demonstrated

the utility of the FRS in

hospitalized elderly

patients who have more

cognitive impairment and

sensory deficits relative to

a community population.

The study also established

that results obtained from

the FRS can be

transformed nonlinearly

to VAS with a high degree

of reliability.

-Secondary analysis -

order in which the

scales were

administered was not

random. Unable to

evaluate possible

carryover effect from

the VAS to FRS.

From FRS responses it

couldn’t be determined

whether subjects are

more influenced by the

faces or by the numeral

labels beneath them.

Subjects may not

consider the smiling

face labeled 0 in the FRS

to be equivalent to 0

(no pain) in the VAS, nor

may they consider the

crying face labeled 5 in

the FRS to be equivalent

to 100 (pain as bad as it

could be) in the VAS.

Although agreement

between the measures

of the 2 scales is

extremely high, the

relationship is complex.

Aside from nonlinear

parametric relationship,

variability increased

significantly with

increased perception of

pain, or equivalently,

reliability of the tools

good.

Jepson BA. Relieving the pain

of pressure sores [letter].

Lancet. 1992;339(8791):503-

4.

Descriptive N=17 patients with 30

distinct PrUs.

No controls.

Pressure ulcers

PrUs treated locally with 3%

benzydamine cream

Cream applied, pain reports

documented 24 and 48 hours after

treatment

After 24 hours of

treatment, 29 of 30 PrUs

were pain free with

complete relief achieved

in all 30 by 48 hours.

No control group.

Patient report of

pain/pain relief.


62


Length of Follow-up

Results Limitations

Evidence Level = V

Prentice WM, Roth LJ, Kelly P.

Topical benzydamine cream

and the relief of pressure

pain. Palliat Med.

2004;18(6):520-4.

Evidence Level = I

Randomized,

double-blind,

placebo-

controlled trial

N=30 hospice inpatients

with cancer

Experimental Group:

n=17 randomly allocated

to benzydamine cream

Control group: n=13 to

placebo.

Mean age = 66.5 years

3 specialist palliative care

units.

Difflan applied to unbroken skin,

either Stage I PrU or peri-wound skin,

but not directly to open wound.

11 point VAS & numeric pain scale

assessments done 24 hours prior to

& immediately following med

application, and at 2, 6, 12 & 24

hours after cream application.

Both tools considered to have good

reliability & validity & equivalent in

assessing pain.

Reduction in pain scores

occurred in both groups,

with Difflam cream

greater, it was not

significantly different

Small sample limited

ability to reach

statistical significance.

Quirino J, Santos VLC,

Quednau TJP, Martins APF,

Lima P, Almeida MRM. Pain in

pressure ulcers. Wounds.

2003;15(12):381-9.

Evidence Level = IV

Exploratory,

descriptive and

cross-sectional

quantitative study

N=20 patients from 3

acute care settings

Inclusion:

-18 years or >

-presence of pressure

ulcer

-cognitive &

communication abilities

to respond to a

questionnaire and

consent to participate in

the study.

Exclusion:

-inability to communicate

-inability to complete

study tools

Data collection tool with 3 parts: 1)

demographic and clinical patient data

including characteristics of the ulcers;

2) pain characterization; 3) qualitative

and quantitative assessment of the

painful condition using a short version

of the McGill Pain Questionnaire

developed by Pimenta, Cruz and

Santos for Brazilian culture and a Pain

Intensity Numerical Rating Scale,

respectively.

PrU presence confirmed and medical

record review to determine their

characteristics

-data concerning pain was obtained

through interviews.

Qualitative variables were compared

by the Fisher exact test and

Pearson’s chi-squared test.

Quantitative variables were

analyzed by the Kolmogorov-

Smirnov Normality test, Student t-

test, and ANOVA. P values <0.05 was

used for statistical significance.

NPUAP PrU staging performed

based on the NPUAP 4 stages.

McGill Pain Questionnaire – used to

assess, discriminate and measure

dimensions of painful experience

(sensitive-discriminative, affective-

motivational, and cognitive-

evaluative). The questionnaire

consists of 78 words divided into 20

categories and describes the

sensitive, affective, and cognitive

aspects of the experience of pain.

For this study, tool was translated &

adapted to Portuguese. Version

used contains 30 pain descriptors

divided into 3 categories (affective,

sensitive and evaluative) A choice

rate higher than 30% established as

the cut-off.

The intensity of pain was measured

with a numerical rating scale

represented by a line numbered

All patients reported PrU

ulcer pain, with 80%

reporting constant PrU

pain, not limited to a

particular time of day

(78.9%), & which did not

affect daily activities

besides movement in bed

and sitting up (80 and

75%, respectively). Mean

pain intensity was 5.80 +

2.93, characterizing a

moderate pain level. The

McGill Questionnaire

showed that sensitive

descriptive elements &

burning were most

frequently used to

describe PrU pain (56.57

and 35%, respectively).

Significant associations

were observed between

painful condition and

ethnic origin (p=0.034),

ethnic origin and impaired

appetite (p=0.014), age

and impaired walking

(p=0.002), and

preferential time of day

and number of ulcers

(p=0.013).

Conclusion: This study

The sample size is

relatively small, and the

study needs to be

repeated, maybe in a

multicentre and/or

prospective format, in

order to confirm the

results obtained and to

allow some

generalizations and

other correlation

investigation


63


Length of Follow-up

Results Limitations

from 0 to 10 where 0=no pain and

10=worst possible pain

may contribute to

breaking the myth of the

absence of pain in

pressure ulcers,

permitting healthcare

workers to understand

this problem in order to

improve pain

management for patients

with pressure ulcers.

Roth RS, Lowery JC, Hamill JB.

Assessing persistent pain and

its relation to affective

distress, depressive

symptoms, and pain

catastrophizing in patients

with chronic wounds: a pilot

study. Am J Phys Med

Rehabil. 2004;83(11):827-34.


Prospective Cross-

sectional

N=69 chronically ill male


wounds from a VA Center

(mean age 59 [24-83

years]),

Severe Group had Stage

III-IV PrU (n=39),

Other Group had Stage II

PrU, postop wounds,

venous or diabetic ulcer

(n=30).

Exclusion:

multiple wounds

Patients followed for up to 6 visits.

All patients queried on 1st visit re:

wound pain, & if present, took series

of pain & other questionnaires.

McGill Pain Questionnaire, Numeric

Pain Rating Scale, Brief Symptom

Inventory, Center for Epidemiologic

Studies Depression Scale, & Coping

Strategies Questionnaire.

28% had wound pain

unrelated to dressing

change, average wound

duration 4.1 months

(range 1-15 months), near

SSD in that those with

Stage III-IV PrU to

experience >pain (35.9%)

than other (16.7%).

Small sample,

correlational design, no

causal direction can be

ascertained, sample not

homogenous with mix

of wounds.

Szor JK, Bourguignon C.

Description of pressure ulcer

pain at rest and at dressing

change. J Wound Ostomy

Continence Nurs.

1999;26(3):115-20.


Descriptive,

comparative study

N=32

Inclusion:

-Stage II-IV PrU

–in acute, home and

extended care settings.

Exclusion: Stage I PrU,

-non-English speaking &

cognitively intact to

sense and report pain.

Mean age 74.7 years (47-

95), =% M & F, Stage II =

12, III = 8, 12 = IV. NSD r/t

age & highest PrU stage.

Pain measured at rest & at dressing

change using McGill Pain

questionnaire

MPQ used as quantitative measure

of PrU pain. Tool has 4 parts; tool

has good reliability & validity.

28 (87.5%) of patients

reported pain at dressing

change & 27 (84.4%)

experienced pain at rest,

& 4 (12.5%) reported no

pain. Of the 28 with pain,

75% rated it mild to

discomforting, 18% as

horrible or excruciating.

12 reported pain as

continuous, occurring at

rest & dressing change.

92% of subjects with Stage

II PrU reported pain, 100%

with Stage III had pain,

and 75% of Stage IV

reported pain. Only 2 (6%)

of subjects had received

pain med for their PrU

pain. Patients with Stage

No control for types of

dressings, use of

pressure reducing

products, pain meds,

etc. Small sample size.

Some subjects who

were acutely ill had

difficulty completing

MPQ.


64


Length of Follow-up

Results Limitations

II, III & IV PrU experience

pain which is often severe

& constant. The number

of word descriptors used

to describe pain directly

in relation to PrU Stage.

Patients with Stage III-IV

reported more constant

pain, Stage II more

transient pain. “Individual

pain assessment should be

included as a standard

part of the initial

assessment of PrUs, &

therefore be assessed on a

regular basis, not just at

dressing change or other

manipulations of the

wound.” P. 119.

Zeppetella G, Paul J, Ribeiro

MDC. Analgesic efficacy of

morphine applied topically to

painful ulcers. J Pain

Symptom Manage.

2003;25(6):555-8.

Evidence Level = I

Randomized,

double-blind,

placebo-

controlled,

crossover pilot

study

5 hospice patients with

advanced cancer &

painful sacral PrU from

4.5 – 14 cm2, PrU could

not be infected or

covered by necrotic

tissue & suitable for

1x/day Intrasite Gel

application, & receiving a

stable analgesic regime

for at least 48 hours.

Treated for 2 days with either 10mg

MSO4 or placebo applied topically to

PrU in am of day 1 & covered with

Tegaderm, 2 day wash out period,

then crossed over for 2 days of

alternate treatment. Rescue analgesia

available in usual way.

VAS used 2x/day, am & pm, to rate

analgesia & to document any local

or systemic side effects

All patients reported

lower VAS scores with

MSO4 compared to

placebo & no local or

systemic adverse effects

attributable to MSO4 (47

v. 15). NSD inpatients’ use

of rescue analgesics

during 2 treatment arms.

Study suggests MS added

topically is effective in

producing local analgesia,

is well tolerated, & no

negative effects.

Small sample, only 1

MSO4 treatment


Length of Follow-up

Results Limitations

Bale S, Dealey C, Defloor T,

Hopkins A, Worboys F. The

experience of living with a

pressure ulcer. Nurs Times.

2007;103(15):42-3.

Qualitative pilot

study, Heideggarian

phenomenology

with interpretative

phenomenological

Eight older adults from

4 centres, 3 in England

& 1 in Belgium.

Inclusion criteria

included older adults

Unstructured interviews which

acknowledged the contribution of

both the participant & researcher.

Three main themes with associated

sub-themes.

Three main themes of

endless pain, a restricted

lifestyle, & coping with

the PrU. Pain was

constant & severe feature

Researchers felt design

fitting to multiple

settings. Limited to older

adults and limited

number of participants.


65


Length of Follow-up

Results Limitations


Care

analysis. with grade 3 or 4 PrU;

exclusion criteria were

spinal cord injury &

inability to provide

informed consent. Age

range 68-101.

Participants had other

co-morbidities.

& analgesia not always

effective. Pain prevented

proper rehab in some.

Cycle of pain, not pain

itself was endless.

Severity of pain not

always recognized by MD.

Pain by repositioning

(conflicts with best

evidence on frequent

repositioning), lie still,

pain relieving equipment.

Pain was restricting

feature with significant

impact on life & feelings

re: self. Worried,

depressed feeling

burdensome, inadequate

& sense of

powerlessness. Disliked

their dependence on

others & change from

former life. Odor was

impacting them. Social

life & general activity

restrictions were the

worst part. Impact on

significant others &

family. PrU also caused

extended hospital stay.

Coping with PrU & the

consequences facilitated

thru comparing self with

others “who had it

worse.” Acceptance of

situation with some

fatalism, & positive

thinking seen as part of

getting on with their

lives.

May not be generalizable

worldwide.

Briggs M, Nelson EA. Topical

agents or dressings for pain in

venous leg ulcers. Cochrane

Database Syst Rev. 2007(4).

Meta-analysis, 6 reviews (total n=317

patients), 3 in 1999

review and 3 in 2003

review.

No trials for persistent pain. 3 studies

in 1999 review & 3 in 2002 review

considered sufficiently similar to pool

Statistically sig in

debridement pain scores

with EMLA 5% cream,

EMLA associated with

in pain scores of 26 mm


66


Length of Follow-up

Results Limitations

Inclusion: persistent

pain, venous leg ulcer,

appropriate statistical

analyses.

on 100 mm scale.

Effect of EMLA on healing

remains unknown.

Davis MDP. Lidocaine patch

helpful in managing the

chronic pain of leg ulceration.

J Am Acad Dermatol.

2003;49(5):964.

Descriptive 11 patients with painful

leg ulcers

All patients treated with 5% lidocaine

patch for pain

Pain improved on

average 51% on a pain

alleviation scale ranging

from 0% (no alleviation)

to 100% (full alleviation).

Flanagan M, Vogensen H,

Haase L. Case series

investigating the experience

of pain in patients with

chronic venous leg ulcers

treated with a foam dressing

releasing ibuprofen. World

Wide Wounds. 2006:1-18.

Case series N=10, 5/5 M/F.

Inclusion: painful

chronic venous leg ulcer

(CVLU) ABPI 0.8 or >,

mod to highly exuding,

VAS pain score 3 or >,

ulcer >2 cm2 & peri-

wound >2 cm from

wound, over 18 years

Exclusion: s/s infection,

steroid treatment, DM,

Lupus, vasculitis,

pregnant or breast

feeding, allergy to

ibuprofen or ASA, need

to wear compression

bandage

Subjects treated with foam ibuprofen

dressing & appropriate compression

bandaging for 6 dressing changes,

followed by treatment with non-pain

relieving foam (Biatain) in non-active

treatment period where dressings

were changed every 2-3 days for 2

weeks.

End points – change in wound pain

intensity & HrQoL

Qualitative interviews @ start of

study & end, diaries maintained thru

out

Pain measured via VAS 24 hours

before study & immediately before

removal of 6th & final dressing 1

week after removal of active

dressing (end of 1st 6 weeks).

Subjects evaluated pain 1 week

after removal of ibuprofen dressing.

Qualitative data also collected.

Leg ulcer Assess form: standard

data including size, photo, etc

Interview at beginning & end of

study, diary thru out.

Sig in mean pain scores

between baseline & final

dressing (85 + 6 v 29 +30,

p<.0003), & sig in VAS

between final dressing &

follow-up visit (29+30 v

14.8, P<.03).

All experienced severe

unrelenting persistent

pain punctuated by

episodes of intense pain.

9 of 10 patients reported

pain reduction within 30

min – 4hrs after

treatment.

Measurement of

patient’s pain is

subjective & subject to

interpretation &

influence of other

uncontrolled variables.

Uni-dimensional rating

scales, e.g., VAS, fail to

reflect multiple

dimensions of pain. Pain

rating differs with time of

day, stress, season, and

mood.

Fox C. Living with a pressure

ulcer: a descriptive study of

patients' experiences. Br J

Community Nurs. 2002;7(6

Suppl):10.

Descriptive

phenomenological

N=5, 31-64 years old, 4

men, 1 woman. PrU

duration 4-36 months;

participants lived in the

community

Semi-structured interview to explore

& describe experiences of patients

living with a PrU.

Three main themes &

sub-themes emerged. 1.

Physical (pain, exudates,

loss of independence), 2.

Psychological (emotional

factors, worry about

healing, relationships,

body image), 3. Social

(social isolation). Pain

was dominant physical

factor & recurring themes

throughout the interview.

Pain varied in level of

intensity & disturbed

sleep. Deep ulcers were

painful.

Freedman G, Cean C, Duron Preliminary N=32 consecutive Patient assigned own pain rating & Pain assessed via Visual Analogue Visual Analogue Scale 18 of the 32 patients


67


Length of Follow-up

Results Limitations

V, Tarnovskaya A, Brem H.

Pathogenesis and treatment

of pain in patients with

chronic wounds. Surg Tech

Int. 2003;11:168-79.

exploratory study patients with chronic

wounds

Modified Functional Independence

Measurement (MFIM). Person

assessing patient made assessment

based on patient completed forms.

Score (VAS) of 0 to 10, with 0

signifying no pain and 10 signifying

the worst pain. Two other variables

included were: the patient’s

(MFIM) and wound surface area.

(VAS)

Modified Functional

Independence

Measurement (MFIM) –

indicates a patient’s

ability to perform basic

self-care and locomotion,

and is measured on a

scale of 0-70, with 70

signifying complete

independence and 0

signifying complete

dependence.

Note: MFIM form and

Pain Assessment form are

included in the article.

experienced pain. On a

scale of 0-10, the average

pain experience by these

patients was 5.08. Pain is

decreased when an

integrated wound

management team is

involved in treatment,

based on results

tabulated from the forms

of patients with multiple

pain scores. The

decrease in pain was

generally correlated with

a decrease in wound

surface area and an

increase in the patient’s

MFIM. The correlation

implies that pain

management facilitates

healing of the wound and

healing results in less

pain. Pain assessment

form is unbiased,

accurate method that

should be used to

measure change of pain

in patients with chronic

wounds. Study had a

small sample size.

Subject’s age not

mentioned.

Gottrup F, Jørgensen B,

Karlsmark T, Sibbald RG,

Rimdeika R, Harding K, et al.

Less pain with Biatain-Ibu:

initial findings from a

randomised, controlled,

double-blind clinical

investigation on painful

venous leg ulcers. Int Wound

J. 2007;4 Suppl 1:24-34.

Double-blind RCT N=122

Ibuprofen Group=62

Control=70

Venous ulcers

Both had foam dressings, but 1

impregnated with ibuprofen.

3 investigation periods: days 1-5, 6-

42, 43-47. Subjects randomized to

treatment group, days 1-5 & 6-42

patients randomized 1:1 to

treatment group. Days 43-47

treatment blinded only to patients.

All crossed over & treatment with

comparative dressing. Persistent

pain & dressing change related pain

assessed days 1-5 & 43-47.

Persistent pain rated bid between

dressing changes using 5 point VRS

& pain intensity on 11-point NBS

Patients in ibuprofen

group experienced

significantly > relief from

persistent pain (p=.0003)

days 1-5; wound pain

intensity significantly in

ibuprofen group days 1-5

(p<.0003), 6.8 baseline to

4.1 (40%).

Dressing change pain

intensity in ibuprofen

group on introduction of


68


Length of Follow-up

Results Limitations

scale. Pain at dressing change rated

on NBS on days 2,5,45, & 47.

non-ibuprofen dressing

(days 43-47). Sig diff pain

intensity (p<.05) at

dressing removal for

ibuprofen group from

baseline NBS values of

0.3 to 0.9 (300%)

compared to constant

levels in non-ibuprofen

group with average NBS

of 2.0 baseline. No diff in

dressing change pain

days 1-5.

Hampton S. Chronic pain in

wounds: a report on 11 case

studies. Nurs Times.

2007;103(15):48-50.

Case series 11 subjects, 45-87 years

(average 74)

Inclusion: adults,

chronic wounds

Pain intensity assessed over 10 days

following application of ibuprofen

impregnated dressing.

Pain intensity assessed on 10cm

VAS scale

On 1st day, lowest scores

were 1-10 with all

Patients having overall

score of 75 (average 6.8).

Overall score 29 on day

10. Level of pain reduced

23% overall following 1st

application & by 61% on

final application of

dressing.

No statistical analysis

used.

Hansson C, Holm J, Lillieborg

S, Syrén A. Repeated

treatment with

lidocaine/prilocaine cream

(EMLA) as a topical

anaesthetic for the cleansing

of venous leg ulcers. A

controlled study. Acta Derm

Venereol. 1993;73(3):231-3.

Randomized,

prospective

parallel-group

study.

N=43

EMLA Group=22

Control Group=21

Inclusion: venous leg

ulcer, systolic ankle

pressure >80mmHg

Exclusion: ulcers <1cm2,

or >50cm2 , history of

sensitivity to local

amide type anesthetics,

treatment with EMLA

cream during previous

month, ongoing local

antibiotic or proteolytic

enzyme treatments.

EMLA group: 8 consecutive

treatments, 2-9 days apart, for 30

min each, then ulcer bed cleansed 10

min after cream removed;

Control group: 8 weekly treatments.

After cream removed, ulcer

examined for edema, redness,

paleness or local reaction & if

present, severity rated as none,

slight, moderate, or severe. VAS

rating for ulcer cleansing done

immediately following & 4 hours

later. 1st & last visits, culture done,

ulcer measured, & granulation &

slough tissue assessed.

Treatment with EMLA

cream significantly pain

from cleansing &

frequency of post-

cleansing pain. Analgesic

effect remained

unchanged with

successive treatments.

NSSD in local reactions or

adverse effects on

granulation tissue, ulcer

area or bacterial flora

between groups.

Treatment times

insufficient for healing to

occur.

Hopkins A, Dealey C, Bale S,

Defloor T, Worboys F. Patient

stories of living with a

pressure ulcer. J Adv Nurs.

2006;56(4):345-53.

Heideggerian

phenomenology.

Inclusion criteria:

>65 years, Stage III-

IV PrU > month,

able to consent.

N=8 (7 from UK & 1

from Belgium) from 4

centers & with 4 data

collectors

Unstructured interviews, use of

probes

Central analysis with identification

of themes & verification by

researchers.

3 themes; endless pain,

restricted life, coping

with PrU. Endless pain

had 4 sub-themes of

constant presence,

keeping still, equipment

Multiple interviewers;

translation of stories;

obtaining sample due to

age limitation presence

of comorbidities; many

had had flap repair;


69


Length of Follow-up

Results Limitations

Exclusion criteria:

SCI

pain, treatment pain.

Underlying current of

sense of powerlessness &

a “never ending story.”

Jorgensen B, Friis GJ, Gottrup

F. Pain and quality of life for

patients with venous leg

ulcers: proof of concept of

the efficacy of BIATAIN-Ibu, a

new pain reducing wound

dressing. Wound Repair

Regen. 2006;14(3):233-9.

Single-blinded cross

over study

N=10

Inclusion: adult, painful

venous leg ulcer >8

week duration, received

compression therapy

for at least 4 week prior

to study

Exclusion: presence of

clinical infection or

cellulitis of peri-ulcer

skin, disease that

interferes with healing.

Pre-treatment period with 2 placebo

dressings (Biatain-pre),

Test treatment period with 5 active

foam dressings containing ibuprofen

Washout period with 2 placebo foam

dressings.

All wore short stretch compression

hose.

3 week study period

Followed 3 weeks. Evaluated q2-3 d,

NBS used to rate pain before &

during dressing change, & 15” after

dressing change.

Mean age 82 years, 66%

females.

Biatain-ibu foam dressing

correlated with in pain

intensity scores from 7 to

2.5. Wearing a Biatain-ibu

dressing before dressing

change reduced pain

during dressing change &

after new dressing

applied, for chronic &

temporary pain. No local

SE of using Biatain-ibu

dressing

Krajnik M, Zylicz Z, Finlay I,

Luczak J, van Sorge AA.

Potential uses of topical

opioids in palliative care--

report of 6 cases. Pain.

1999;80(1-2):121-5.


Care

Case review Six cases of patients

treated with topical

opioids. Cutaneous pain

due to tumor

infiltration, skin ulcers

of malignant & non-

malignant origin, severe

oral mucositis, pain d/t

knee arthrosis, & severe

tenesmoid pain.

Case review. Patients received 0.1%

morphine gel

Pain relief Patient. A: (89 y/o) with

3x7cm painful & inflamed

subq upper tibial

infiltrate. Pain 4-8 pre-

and 0-2 post. Patient B:

(56 year old) cutaneous

pain with sacral &

colostomy infiltration.

Pain pre4-10 and post- 1

until last week of life it

was occasionally 6.

Patient C: (71 y/o) severe

oral mucositis, pain pre-

10 & post- 2-4. Patient D:

(71 y/o) painful necrotic

leg ulcers, pain pre- 10 &

post- 4. Patient E: (69

y/o) with cancer of

larynx, pain pre- 9 & post-

2-4. Patient. F: (62 y/o)

vulvar cancer, pain pre- 6

& post- 2. Opioid

receptors are inactive in

non-inflamed tissue.

After onset of

inflammation, opioid

Observation periods

were short. Application

of gel to open wound is

difficult, especially with

much exudates, & much

of drug may be flushed

away. Need to identify

how morphine absorbed

through healthy skin, as

is poor thru intact

epidermis, but when

epidermis removed,

bioavailability is 75%. Is

morphine absorbed

systemically rather than

locally?


70


Length of Follow-up

Results Limitations

receptors become

activated within hours.

Morphine & diamorphine

appear to do equally well.

Krasner D. Using a gentler

hand: reflections on patients

with pressure ulcers who

experience pain.

Ostomy/Wound

Management. 1996;42(3):20.

Heideggerian

hermeneutical

phenomenology

with PrUs

N=42 nurses providing

care to patients with

PrUs

Nurses asked to write brief

description about experiences with

patients with PrU pain.

Three consecutive

patterns and 8 themes

identified.

Langemo DK, Melland H,

Hanson D, Olson B, Hunter S.

The lived experience of

having a pressure ulcer: a

qualitative analysis. Adv Skin

Wound Care. 2000;13(5):225-

35.


Care

Spiegelberg’s

phenomenological

method –

descriptive,

qualitative

N=8, Non-probability,

purposive sample, 4

with PrU & 4 with

previous PrU (Stage II-

IV). Four had SCI & 5

had surgical flap

reconstruction; 2 had

MS, 1 was bipolar,

alcoholic, & 1

degenerative

neuromuscular

disorder. Males=7,

female=1, mean age

35.7 year, range 27-52

year. 6 of 8 had

multiple PrU, all 4

current Patients with

PrU were Stage IV

Unstructured, face to face, audio-

taped interview. Field notes taken.

Each person asked to respond to

“Please describe your experience of

having a PrU. Share all the thoughts,

perceptions, & feelings you can recall

until you have no more to say about

this experience.” Used relevant

probes to elicit additional data.

Demographic info also obtained.

Interviews transcribed verbatim,

accuracy verified. 3 researchers

ensured content validity. Colaizzi’s

content analysis established via

reading transcriptions, extracting

significant statements & phrases

directly related to lived experience,

meaning formulated from

significant statements & phrases,

formulated meanings organized into

clusters of themes, & researchers

integrated results into exhaustive

description of the lived experience.

7 themes emerged:

perceived etiology of PrU,

life impact & changes

(physical, financial &

social), psycho-spiritual

impact (body image

changes, struggle with

stereotypes,

desire/struggle for

control & independence,

spiritual impact), extreme

painfulness with PrU

(pain Intensity &

duration, analgesic use),

need for knowledge &

understanding

(knowledge of

prevention, physiologic

processes & lack of

knowledge), need for &

effect of numerous

stressful treatments (self-

care, treatment regimens

& multiple surgeries,

complications, length of

healing time), & grieving

process (denial,

depression, anger,

bargaining, acceptance).

Limited to Caucasians,

young or middle age, in

Midwest area of US.

Need replication in other

ethnic groups & urban

areas. Not followed

longitudinally.

Lok C, Paul C, Amblard P,

Bessis D, Debure C, Faivre B,

et al. EMLA cream as a topical

anesthetic for the repeated

Randomized,

double-blind,

placebo-controlled

study

N=69;

EMLA group=36

Placebo Group=33

All patients received oral

dextropropoxyphene 30mg &

acetominophen 400mg 1 hour before

debridement. EMLA group received

VAS 10-cm scale

Length of follow-up 15 treatment, if

>15 needed, patient d/c from study.

NSD between groups on

demographics. EMLA

cream sig VAS pain

scores for debridement

Study at multiple centers,

so can be difficulty

controlling for

methodology &


71


Length of Follow-up

Results Limitations

mechanical debridement of

venous leg ulcers: a double-

blind, placebo-controlled

study. J Am Acad Dermatol.

1999;40(2 Pt 1):208-13.

Inclusion: venous ulcer

(5-50 cm2 ) with necrosis

on 50% or > of ulcer

area, needs

debridement at least 3x

during 1st week, no

previous use of EMLA

cream

thick layer of EMLA cream, covered

with plastic wrap for 30-45”, cream

removed & debridement begun

within 10”. Placebo cream for control

group. Post debridement wound

covered with Vaseline gauze. MD

determined frequency of

debridement after week 1, max of 15

debridements allowed. Elastic

compression bandage standard

treatment at 6 centers & for some

patients at 2 other centers. Bandages

& dressings removed qd to assess

need for debridement.

Ulcer CLEAN if 75% or > free from

necrotic & fibrinous tissue & crusts.

Size measured via tracing. Pa

by 50% (p=.003). EMLA

cream produced

satisfactory analgesia for

mechanical debridement

for up to 15 repeated

sessions.

EMLA group had sig

debridements until clean

(11.5 v >15) & this can

have +$$ savings.

Number of patients who

interrupted debridement

d/t pain sig in EMLA

group (41.7%) v placebo

group (75.8%).

assessments.

Munter KC, Beele H, Russell L,

Crespi A, Gröchenig E, Basse

P, et al. Effect of a sustained

silver-releasing dressing on

ulcers with delayed healing:

the CONTOP study. J Wound

Care. 2006;15(5):199-206.


Care & Table 9 Dressings

Comparative open

prospective parallel

& block-

randomized study.

Total 18 month

study period.

N=619

Inclusion: 18 or >, not

pregnant or lactating,

chronic wound with

delayed healing & mod-

high exudates

Exclusion: depth <0.5cm

8% were PrUs.

Patients Randomized to either silver

foam or LBP & followed weekly for 4

weeks. At q visit wound assessment

made & dressing change.

HRQoL at 1st & final visits done.

Endpoints in ulcer size, exudates, or

change in wound bed composition,

HRQoL, cost effectiveness

Pain measured on 10-pt scale,

measured at q dressing change

Median rating of pain at

dressing changes in

silver foam than LBP

group (p<.0001 week 1,

p<.0011, week 2) & in

between dressing

changes.

Silver foam group had >

in wound area (58.5% v

33.3%), less maceration,

better exudates

management, & faster

in odor than LBP group.

LBP included a multitude

of dressings, thus large

sample required to offset

this.

Rastinehad D. Pressure ulcer

pain. J Wound Ostomy

Continence Nurs.

2006;33(3):252-6.

Phenomenological,

qualitative study

N=10, Purposeful

sampling of acute care

patients with a PrU, 7

female & 3 male, 30-90

years of age. 8 had pre-

existing PrU & 2 PrU

developed in hospital.

Multiple taped interviews done along

with field notes and transcripts of

interviews generated. Data collection

over 8 months & analysis over 16

months

Semi-structured interviews using

decision trail, interviews taped &

transcribed, field notes done to

support data analysis & theme

identification. Analysis reviewed by

10 researchers & 2 WOCN nurses.

Most had Stage II PrU, 2

had Stage III & 1 had

Stage IV, with majority on

sacrum, with 1 on heel &

1 scapula. 22 themes and

1 constitutive pattern

identified. Multiple terms

used to describe pain

Majority of patients with

a PrU experience pain of

varying intensities, many

severe, which was

consistent with Dallam,

Limited to 10 subjects.


72


Length of Follow-up

Results Limitations

Langemo, & Szor.

Emotions of frustration,

depression, anger & rage

also reported. The pain

experience from a PrU

permeates their

existence.

Sibbald RG, Coutts P,

Fierheller M, Woo K. A pilot

(real-life) randomised clinical

evaluation of a pain-relieving

foam dressing: (ibuprofen-

foam versus local best

practice). Int Wound J. 2007;4

Suppl 1:16-23.

Open comparative

prospective block-

randomized design.

Pilot study.

Vast majority

venous ulcers.

N=24

Inclusion: adults with

chronic pain with mod-

highly exudating leg

ulcers; minimal wound

size 0.5x0.5 cm & max

would have to be

covered by 10x10 cm

dressing. Able to

comprehend & rate

pain & do pain diary. All

pain & other meds to

be unchanged for 1

week of study.

Exclusion: known

contraindication or

allergy to ibuprofen or

NSAID, females


ulcer down to tendon,

muscle or bone, or

symptoms of bacterial

burden.

Ibuprofen Group=12

LBP Group=12

Randomized to 1 week trial.

Ibuprofen Group (N=12) received

foam dressing with ibuprofen,

LBP Group (N=12) received moist

dressing with active anti-microbial &

anti-inflammatory components

Pain intensity measured bid on 10-

point NBS (Numeric Box Scale), pain

relief on 5-point VRS & diary with

am & pm recordings.

Baseline & final ulcer assessments

done. Patients maintained regular

concomitant meds during study.

Followed for 1 week

For ibuprofen group,

additive am scores sig

(p=.04) & pm scores sig

(p=.02), sig correlation

between am & pm scores

(r=.85, p<.0001), & with

pooled am & pm scores

(p=.0217). Sig in acute

wound pain intensity

after last dressing

removal (p=.04).

Sig in ulcer area in

ibuprofen group (p=0.05)

& ibuprofen group also

had > granulation tissue.

No blinding, & subjects &

researchers aware

dressing contained active

analgesic. Patient pain

assessment is subjective.

Pilot study.

Spilsbury K, Nelson A, Cullum

N, Iglesias C, Nixon J, Mason

S. Pressure ulcers and their

treatment and effects on

quality of life: hospital

inpatient perspectives. J Adv

Nurs. 2007;57(5):494-504.

Qualitative semi-

structured

interviews

Inclusion criteria:

Exclusion criteria:

Purposive sample, N=23

hospitalized patients

(M=5, F=18), 33-92

years (median 78

years). Highest PrU

locations heel &

sacrum. PrU stages II-V.

Semi-structured interview; verified

meaning and understanding

throughout interviews; interviews

recorded & transcribed.

Identification of themes & sub-

themes

91% (21/23) said PrU &

treatment affected lives

emotionally, physically,

mentally & socially.

Dependent on others to

treat, manage, and care

for PrU. Pain, discomfort

& distress of PrU not

acknowledged by nursing

staff. 7 patients blamed

Impossible to separate

effect of PrU from

chronic condition.


73


Length of Follow-up

Results Limitations

health care prof for

getting PrU, 8 blamed it

on comorbidities, , 3 on

poor hygiene practices or

lack of knowledge. 91%

had PrU pain, & 2 who

didn’t either had neuro

condition or were

unaware of PrU. PrU

associated with pain,

fluid leakage & smell,

discomfort, & mobility

difficulties.

Vanscheidt W, Münter KC,

Klövekorn W, Vin F, Gauthier

J, Ukat A. A prospective study

on the use of a non-adhesive

gelling foam dressing on

exuding legs ulcers. J Wound

Care. 2007;16(6):261-5.

Non-adhesive gel foam

dressing, Versiva


Care

Pre- Post,

Prospective open

label comparative

study.

N=46

50% male, 50% female

Inclusion: heavily

exudating leg ulcer

Exclusion: sensitivity to

GFD-N, history poor

adherence, arterial

ulcer, required wound

filler on enrollment

Baseline data, pain level, peri-ulcer

skin info collected. Wound cleaned,

debrided & measured. Subjects

treatment with non-adhesive gelling

foam dressing & compression for 28

days & pain assessed. At least weekly

clinic visits.

Outcome measure=pain intensity

rated on VAS 10-point scale.

Length of follow-up 28 days or

withdrawal from study, whichever

came 1st.

Primary endpoint safety, 2nd

endpoint measures of dressing

performance, exudates

management, ease of use &

pain/comfort.

Mean pain VAS intensity

rating >50% for 1st clinic

dressing change

compared to pre-study

(4.7 v 23, p<.001) & on

removal (3.9 v 1.7,

p<.001). Peri-wound skin

condition better for 31%

(p=0.006). GFD-N

dressing associated with

SSD in ulcer pain with

dressing in place & during

removal. Of 46 subjects,

11% healed the ulcer &

78% improved in 4 or <

weeks.

GFD-N was safe, effective

& convenient for wound

healing, exudates

management,

pain/comfort & ease of

use.

Subjects used as own

control, no RCT, no true

control group.


74

Table 5. Support Surfaces for Treatment of Pressure Ulcers Direct Evidence - Adult


Length of Follow-up

Results Limitations

Attard J, Rithalia SV, Kulkarni

J. Pressure relief

characteristics in alternating

pressure air cushions.

Prosthet Orthot Int.

1997;21(3):229-33.

Evaluation of 4

alternating pressure

air cushions (APAC).

10 healthy volunteers None Interface pressure (IP)

measurement in sitting position

Some of the devices did

not relieve pressures

below 20mmHg even

with complete deflation

of air cells.

Healthy subjects. No

patients with PrUs. No

follow-up.

Bell J. The role of pressure-

redistributing equipment in

the prevention and

management of pressure

ulcers. J Wound Care.

2005;14(4):185-8.

Review of published

papers on pressure

reducing and

pressure relieving

mattresses

Article deals with

evolution of pressure

redistributing surfaces

and interface pressure

measurement, but not

PrU directly.

Defloor T, Grypdonck MH. Do

pressure relief cushions really

relieve pressure? West J Nurs

Res. 2000;22(3):335-50.

Evaluation of 29

seating cushions

and sheepskin.

20 healthy volunteers None Interface pressure (IP)

measurement in sitting position

Gel cushions and

sheepskin have no

pressure reducing effect

Some types of foam

cushions decrease while

others increase IP. Air

cushions had the lowest

IP.

Healthy subjects. No

patients with PrUs. No

follow-up.

Makhsous M, Rowles DM,

Rymer WZ, Bankard J, Nam

EK, Chen D, et al. Periodically

relieving ischial sitting load to

decrease the risk of pressure

ulcers. Arch Phys Med

Rehabil. 2007;88(7):862-70.

Repeated measures

of 2 sitting push-up

protocol

20 normal, 20

paraplegic and 20

tetraplegic subjects

1 hour protocol with Alternate &

Normal plus push-up

Alternate was 10 min normal sit & 10

min sit without ischial support

Normal plus was 20 min normal sit

followed by pushup or lift of subjects

Interface pressure on seat & back

rests

Significantly lower

average pressure over

buttocks with alternate

sitting protocol

1 hour study duration

No follow-up

No gender

differentiation

Lack of BMI control

Unrelated to PrU

outcome

Nixon J, Nelson EA, Cranny G,

Iglesias CP, Hawkins K, Cullum

NA, et al. Pressure relieving

support surfaces: a

randomised evaluation.

Health Technol Assess.

2006;10(22):iii.

Multicenter RCT,

open, fixed sample,

parallel-group trial

11 hospital based

research centers in UK

Alternating pressure mattress (n=982)

or overlay (n = 989)

Development of new PrU – stage 2

or greater; healing of existing PrU

No statistically significant

difference in proportions

of patient developing

PrU, healing time.

Reduced LOS on mattress

resulted in some cost

savings

No length of follow-up

given.


75


Length of Follow-up

Results Limitations

Ochs RF, Horn SD, van Rijswijk

L, Pietsch C, Smout RJ.

Comparison of air-fluidized

therapy with other support

surfaces used to treat

pressure ulcers in nursing

home residents. Ostomy

Wound Manage.

2005;51(2):38-68.

Retrospective 664 NH residents 3 mattress groups Healing rates Healing greatest for air-

fluidized beds; mean

healing rates greater for

Stage III & IV PrUs on air-

fluidized beds

Ooka M, Kemp MG, McMyn

R, Shott S. Evaluation of three

types of support surfaces for

preventing pressure ulcers in

patients in a surgical intensive

care unit. J Wound Ostomy

Continence Nurs.

1995;22(6):271-9.

New product

evaluation, 3-

month study period

110 patients in SICU Patients placed on either a static

foam or dynamic surfaces

Braden scale, PrU occurrence

3 patients on each of the

3 support surfaces

acquired 17 PrUs. No

difference between

support surfaces

Limited follow-up

Purvis K et al. How the use of

electric profiling beds can

reduce the prevalence of

pressure ulcers. Prof Nurse.

2005;20(8):46-8.

18-week pilot study

reviewing hospital

acquired PrU

prevalence and

appropriateness of

equipment

selection

Patients in medical and

surgical wards with a

Braden score of 18 or

less

Hospital wide supply of 564 electric

profiling beds, seating and dynamic

mattress systems for high risk pts.

Improved patient education,

repositioning, nutritional needs and

skin care.

PrU prevalence rates in the pilot

wards

PrU prevalence reduced

from the initial 8.9% to

4% at the end of the 18-

week period.

No information about

number of subjects, lack

of sample size.

Rosenthal MJ, Felton RM,

Nastasi AE, Naliboff BD,

Harker J, Navach JH. Healing

of advanced pressure ulcers

by a generic total contact

seat: 2 randomized

comparisons with low air loss

bed treatments. Arch Phys

Med Rehabil.

2003;84(12):1733-42.

Randomized

prospective cohort

study (2 studies)

207 long-term care pts.,

stage III or IV PrUs.

3 support surfaces: low-air loss,

upgraded bed overlay, 4hour/day

experimental generic total contact

seat

Number of subjects healed, time to

healing, PrU status score after 4

weeks of treatment; followed 6

months or until healed

Generic total contact seat

superior to low air loss

bed therapy

Russell LJ, Reynolds TM, Park

C, Rithalia S, Gonsalkorale M,

Birch J, et al. Randomized

clinical trial comparing 2

support surfaces: results of

the Prevention of Pressure

Ulcers Study. Adv Skin Wound

Unblinded,

randomized,

prospective trial

1168 elderly acute care

patients

1-experimental devices

2-standard devices

Development of nonblanching

erythema

Experimental device

proved better for

preventing blanching

erythema but not

significant for non-

blanching erythema


76


Length of Follow-up

Results Limitations

Care. 2003;16(6):317-27.

Warren JB, Yoder LH, Young

McCaughan S. Development

of a decision tree for support

surfaces: a tool for nursing.

Medsurg Nurs. 1999;8(4):239-

45.

Pilot project to

develop a decision

tree for support

surface selection

Sample size not

reported

Skin assessment, PrU risk factor

assessment, Braden scale risk

assessment.

6 support surfaces used.

Reduction in PrU occurrence 50% reduction in PrU

prevalence rate over a 2-

year period

Lack of sample size, no

statistical analysis, lack

of end-point data.

Indirect Evidence - Pediatric Reference Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Law J. Transair Paediatric

Mattress replacement system

evaluation. Br J Nurs.

2002;11(5):343-6.

Observational study Four children who were

at high risk of

developing

pressure injury and who

had been nursed in

both the acute and

community sectors

evaluated the Transair®

Pediatric Mattress.

NA They were each nursed on the

Transair® Pediatric Mattress for a

period ranging between 4 and 10

weeks (with an average period of

use being 6.16 weeks).

The children were assessed for skin

damage and comfort.

Of the four children who

used this system, no child

experienced

skin damage while being

nursed on theTransair®

Pediatric Mattress.

The responses received in

each case were entirely

positive.

Very small sample size

No control group

Non Randomized

McLane KM, Krouskop TA,

McCord S, Fraley JK.

Comparison of interface

pressures in the pediatric

population among various

support surfaces. J Wound


. 2002;29(5):242-51.

Descriptive Study

design

A convenience sample

of 54 healthy children

from the community

ranging in age from

infancy through 18

years was selected.

The total sample size

consisted of 54

children: 24 girls and 30

boys. Their ages ranged

from 3 months to 16

years. Their weight

ranged from 6.43 kg to

98.1 kg, and their

height

ranged from 59.5 cm to

185 cm

NA A comparison was done to

evaluate interface pressures under

the occiput for infants to children

younger than 6 years of age and

under the occiput, coccyx, and heel

for 6- to 18-year-olds.

Five surface combinations were

used for measurements.

The instrument used to measure

the interface pressures was the

Mini-Texas Interface Pressure

Evaluator.

The standard hospital

mattress yielded the

highest interface

pressures.

The Delta Foam overlay

alone or in combination

with the Gel-E-Donut

pillow produced the

lowest occipital pressures

in all age groups.

The Delta foam overlay

produced comparable

pressures to the Efica low-

air-loss bed when

measuring the coccyx and

heel interface pressures.

The Delta Foam overlay

The Efica Hill Rom low-

air-loss bed did not have

individual zone

adjustments for children

weighing less than 50 lb.

There was some

variability in the use of

support surfaces in the

infant to < 2 year group.

There was also

variability in the

positioning of the

surfaces that were used.

Non-Randomized study


77


Length of Follow-up

Results Limitations

alone or in combination

with the Gel-E-Donut

pillow is a cost effective

and therapeutic choice for

pressure redistribution as

demonstrated in this study

of healthy children.

The highest interface

pressure measurements

obtained in children 6 to

16 years of age were

under the perpendicular

heel. This pressure was

greatly reduced when the

heel was repositioned so

the ankle was on its side in

the oblique position.

Solis I, Krouskop T, Trainer N,

Marburger R. Supine

interface pressure in children.

Arch Phys Med Rehabil.

1988;69(7):524-6.

Observational study 13 healthy children

ranging in age from 10

weeks to 13.5 years

were selected for this

study.

The mean age was

7years 3 months.

NA

The study examined interface

pressures generated under

different prominences (occipital,

scapular and sacral)

Relationships between interface

pressure under the occiput,

shoulders and sacrum and

Mechanical characteristics of

surface used to support a child.

A standard mattress, then a 2 inch

and a 4 inch convoluted foam

overlay were the surfaces used in

the study.

The differences in

pressures between the

occiput and scapula,

occiput and sacrum and

scapula and sacrum were

significant (p<0.01), with

the highest pressures

recorded under the

occipital area. Occipital

pressures decreased from

45.7mm Hg on the

standard mattress to

22.3mm Hg on the 4inch

overlay in ages 0 to 2,

54.3mm Hg to 30.5mm Hg

in ages 2 to 10, and

78.0mm Hg to 42.4mm Hg

in ages 10 to 14. Sacral

pressures were highest in

older and larger children,

increasing from 17mm Hg

in ages 0 to 2 to 34mm Hg

in ages 10 to 14, and when

body surface area was

greater than 1m2. These

results indicate that the

site of greatest pressure

Small sample

No control group

No randomization


78


Length of Follow-up

Results Limitations

changes with increasing

age from the occipital area

to the sacral area.

Therefore different

pressure redistribution

considerations are

necessary in treating

pediatric patients than in

managing pressure under

adults.


79

Table 6. Cleansing Direct Evidence


Length of Follow-up

Results Limitations

Konya C, Sanada H, Sugama J,

Okuwa M, Kitagawa A. Does

the use of a cleanser on skin

surrounding pressure ulcers

in older people promote

healing? J Wound Care.

2005;14(4):169-71.


Quality: Fair

Subjects divided

into 2 groups:

Normal Saline (NS)

group April 2000-

March 2002,

cleanser (CL) group

April 2001-March

2002. No blinding

or randomization.

189 patients >65 years

old in LTC with stage II

or > PrU: NS group had

84 patients with 95

ulcers. CL group had 90

patients with 90 ulcers.

Compare NS vs. CL in reducing healing

time

Measured time to heal using

Kaplan-Meier

Irrespective of stage,

healing time shorter with

pH balanced cleanser

especially in stage II

Nurses were not blinded

and cleanser lathered

which may have

facilitated more

aggressive cleansing.

Ulcer location not

mentioned and

lathering may have

been more beneficial

for contaminated sacral

ulcers.


Kitayama Y, Ishikawa S,

Togashi H, et al. Skin debris

and micro-organisms on the

peri-wound skin of pressure

ulcers and the influence of

peri-wound cleansing on

microbial flora. Ostomy

Wound Manage.

2005;51(1):50-9.

Evidence Level = V

Quality: Good

Also in Table 10 Infection

Descriptive study of

17 long-term care

(LTC) patients

(patients) with

stage III/IV ulcers

17 ulcers: 7 sacrum, 7

trochanter, 3 ischial

Collect & analyze skin debris found on

peri-wound skin of patients with

pressure ulcers & to evaluate effect of

peri-wound cleansing on micro flora on

peri-wound & wound bed

Skin debris collected: wound bed,

1 cm (peri-wound) and 10 cm

(normal skin) from wound before

cleansing, protein largest quantity

of skin debris (keratinized cells),

counts increased with the amount

of protein

Per wound cleansing

caused a decrease in

wound/peri-wound

microbial counts so

authors suggest peri-

wound cleansing daily

Sample size small; also

location of ulcer (area of

contamination) may

affect microbial load;

elderly population only,

effect on healing was

not studied

Moore ZEH, Cowman S.

Wound cleansing for pressure

ulcers. Cochrane Database

Syst Rev. 2005(4):CD004983.

Evidence Level = I

Quality: Strong

Systematic review 3 RCTs were included.

Overall sample sizes

were small with mean

of 60 (range 8 to 123)

To assess effects of cleansing solutions

and techniques on healing rates of

pressure ulcers

Healing rates of pressure ulcers No studies compared

cleansing with no

cleansing

Need for further

research. Little RCT

evidence available on

wound cleansing for

pressure ulcers.


Length of Follow-up

Results Limitations

Clinical update. Solutions,

techniques and pressure in

wound cleansing. Aust Nurs J.

Systematic review

with

recommendations

Grade A- effectiveness established

to degree that merits application

Grade B-effectiveness established

Chronic wounds may be

cleansed with potable

water (Grade B); boiled &


80


Length of Follow-up

Results Limitations

2006;14(1):20-3.

Quality: Good

to degree that suggests application

Grade C- effectiveness established

to degree that warrants

consideration

Grade D- effectiveness established

to limited degree

Grade E- effectiveness not

established

cooled water is a viable

alternative (grade C).

Irrigation with povidone

iodine is recommended for

contaminated wounds

(Grade B) but no evidence

of the time it should be

left in place (Grade E).

Showering of chronic

wounds undertaken with

caution (Grade C).

Whirlpool may improve

healing rate in PrU (Grade

C). Soaking in povidone-

iodine is not effective in

reducing bacterial counts

(Grade B).

Solutions, techniques and

pressure for wound cleansing.

Joanna Briggs Institute Best

Practice. 2006;10(2):1-4.

Systematic review

with

recommendations

14 RCTs: 4 studies with

lacerations; 1 with

traumatic wounds,

open fractures or ulcers

and 7 postoperative

wounds.

Multiple solutions, techniques and

pressures used in wound cleansing

Grade A- effectiveness established

to degree that merits application

Grade B-effectiveness established

to degree that suggests application

Grade C- effectiveness established

to degree that warrants

consideration

Grade D- effectiveness established

to limited degree

Grade E- effectiveness not

established

Use potable water for

irrigation when saline

unavailable; run tap for 15

sec. Boiled and cooled

water effective in absence

of saline or potable water.

Same recommendations as

above for povidone iodine

in contaminated wounds

(B). Soaking in 1%

povidone iodine not

effective in reducing

bacterial counts (B). 13 psi

irrigation pressure

effective in reducing

infection and

inflammation in

lacerations and traumatic

wounds (B).

Multiple types of

wounds. Recommend

reading full report at:

http://www.joannabriggs

.edu.au/pdf/BPISEng_10_

2.pdf

Beam JW. Wound cleansing:

water or saline? J AthlTrain.

2006;41(2):196-7.

Quality: Strong

Random/quasi

random

Electronic databases Rates of infection/healing 24 studies of which 9 met criteria No difference in rates of

infection/healing between

tap water/saline in

cleansing of acute/chronic

wounds

Method quality of

studies, more studies

needed

Fernandez R, Griffiths R.

Water for wound cleansing.

Cochrane Database Syst Rev.

Randomized/quasi

random

Searched electronic

databases

Assess the effects of water compared

with other solutions

Objective/subjective measures of

wound infection or healing

5 trials, 3 compared

cleansing with no

cleansing, 1 compared

No standard criteria for

measuring infection

which limited ability to

http://www.joannabriggs.edu.au/pdf/BPISEng_10_2.pdf




81


Length of Follow-up

Results Limitations

2008(1).

Quality: Strong

cleansing with procaine

spirit, risk of developing

infection when cleansed

with tap water compared

with saline was 0.16, no

diff in infection rates when

wounds cleansed with tap

water vs. not cleansed at

all

pool data

Fernandez R, Griffiths R, Ussia

C. Effectiveness of solutions,

techniques and pressure in

wound cleansing. JBI Reports.

2004;2(7):231-70.

Systematic review

of randomized &

clinical controlled

trials

Electronic databases Assess effectiveness of different

solutions, pressures, & techniques

14 randomized trials-no

difference in

infection/healing rates in

acute/chronic wounds

with either tap water or

saline, irrigation pressure

of 13 psi for both children

& adults, 1 study with low

power to support use of

potable water, povidone-

iodine for contaminated

wounds

Horrocks A. Prontosan wound

irrigation and gel:

management of chronic

wounds. Br J Nurs.

2006;15(22):1222.

Quality: Fair

Before and after

study

10 patients with chronic

wounds

Evaluate 10 patients in community

with chronic wounds, previous.

treatment with NACL > 1month

Wound size, patient comfort, ease

of application, compare use of

antibiotic/silver prior to & during

use of Prontosan®

7 of 10 patients reduced

wound size after 3 weeks

Wounds “appeared” to

contain biofilm, sample

small, 1 PrU

Svoboda SJ, Bice TG, Gooden

HA, Brooks DE, Thomas DB,

Wenke JC. Comparison of

bulb syringe and pulsed

lavage irrigation with use of a

bioluminescent

musculoskeletal wound

model. J Bone Joint Surg Am.

2006;88A(10):2167-74.

Quality: Good

In-vivo study

involving goats

12 adult male goats Compared efficacy of pulsed lavage

and bulb syringe in reducing bacterial

counts in contaminated wound from

animal model

Used bioluminescent bacteria to

allow for changes in quantity &

distribution of bacteria to be

visualized with multiple volumes of

irrigant

Pulsed lavage more

effective than bulb syringe

in reducing bacteria

luminescence after 6 & 9 L

of irrigation

Animal musculoskeletal

model, used acute

wounds, bacteria may not

be representative of what

is found in chronic

pressure wounds

Valente JH, Forti RJ,

Freundlich LF, Zandieh SO,

Crain EF. Wound irrigation in

children: saline solution or

tap water? Ann Emerg Med.

Prospective

randomized trial

over 14 months

Patients aged 1-17

years with simple

laceration seen in urban

pediatric emergency

department. 530

Compare infection rates of wounds

irrigated with saline vs. running tap

water.

Saline-100 ml with 30-60 syringe & 18

gauge angiocath vs. running tap water

Patients seen initially then within

48-72 hours for signs of wound

infection.

14 wounds infected-- 7 in

saline group and 7 in

water group

Lacerations and not

chronic wound like

pressure ulcers, selection

bias using odd and even

days for patient selection


82


Length of Follow-up

Results Limitations

2003;41(5):609-16.

Quality: Strong

patients enrolled for 10 sec (approximately 1.5 L).

to group, water not

tested for particulate

matter

Wilson JR, Mills JG, Prather

ID, Dimitrijevich SD. A toxicity

index of skin and wound

cleansers used on in vitro

fibroblasts and keratinocytes.

Adv Skin Wound Care.

2005;18(7):373-8.

Quality: Good

In vitro cellular

model with

fibroblasts &

keratinocytes

17 cleansers and 3

liquid bath soaps

Evaluated cleansers effect on human

infant dermal fibroblasts and

epidermal keratinocytes exposing

them to 10 serial dilutions

Skin cleansers were most toxic to

fibroblasts with indexes between

10,000 to 100,000

In-vitro monolayers of

normal human skin cells

(fibroblasts, keratinocytes)

are reliable models for

screening for toxicity of

cleansers

In vitro, so difficult to

translate into pressure

ulcer wounds


83

Table 7. Debridement Direct Evidence


Length of Follow-up

Results Limitations

Alvarez OM, Fernandez-

Obregon A, Rogers RS,

Bergamo L, Masso J, Black M.

A prospective, randomized,

comparative study of

collagenase and papain-urea

for pressure ulcer

debridement. Wounds.

2002;14(8):293-301.

Evidence Level = II

Prospective,

randomized,

parallel, group, tri-

center, open-label,

clinical trial

N=28 subjects (nursing

home patients);26

completed study (2

dropped out early 2

unrelated treatment

issues)

Inclusion:

18 years of age

Stage II, III & IV

PrUs

Nonviable tissue

attached to ulcer

base

If ulcer located on

feet, must have

ABI 0.75 or

normal PVR to r/o

arterial disease

Exclusion:

Clinical signs of

infection

Cellulitis

Osteomyelitis

Inadequate

nutrition

Uncontrolled DM

Renal, hepatic,

hematological,

neurologic, or

immunological dz.

Patients on

corticosteroids,

immunosuppressive

agents, radiation or

chemo within 1 month

prior to study entry

1-2 week screening period to stabilize

wound & institution of physical &

supportive treatment:

-Cleanse with sterile NS

-Dress with nonadherent 1 dressing

-NS moist to moist dressing

- dressing daily & prn

* After screening period, if target ulcer

& area of necrosis stable ( 20% in

size) or improving ( in size), patient

advanced to

randomization

Papain/Urea (n=14)

Collagenase: (n= 12 evaluable)

Treatment protocol:

-If thick hard eschar is present, cross-

hatch with # 10 blade

-Cleanse with NS

-No forceful irrigation

-Apply study medication over entire

surface of nonviable tissue (1 x daily

using a tongue depressor (approximate

thickness of a nickel, 2 mm) (* If the

dressing dislodged or soiled, only 1

additional application of test agent

allowed)

-Apply lightly fluffed NS moistened

gauze

-Cover with dry gauze

-All subjects were placed on pressure

redistribution sleep surfaces & chair

cushions (selection was determined by

the investigational team & dependent

upon ulcer location & consistent with

the AHCPR Guidelines)

-Subjects confined to bed were

-Ability to effectively debride

devitalized tissue in PrUs

-Tracing & wound assessment

education performed for all study

personnel prior to study initiation

(interrater reliability was 91% for

clinical evaluations & 94% for

tracings)

-Subjects were evaluated prior to

screening & weekly during

screening for a min of 1 week

-Speed of debridement was

evaluated 1 x/week for the 1st

week, then 2x/weekly for 3 weeks

-Non-viable tissue was described

as:

Adherent yellow/gray/white

slough

Adherent soft black eschar

Firmly adherent black eschar

Line of demarcation between

nonviable & viable was

measured

% of wound coverage with

nonviable tissue was

objectively measured using

tracings

Wound surface area &

attached tissue were

determined by computerized

planimetry of surface

tracings made with acetate

transparent film

-Wound evaluation included:

Overall wound condition

Edges (undermining)

Odor

Wound pain

Exudate

Peripheral tissue

-1 Efficacy endpoint was

resolution of nonviable

tissue

-Other endpoint was

presence of granulation

tissue

-No demographical

differences between

groups

-No significant difference

(p 0.05) between groups

with respect to ulcer size

& amount of nonviable

tissue @ baseline

-Ointment application was

considered easy &

convenient

-Papain-urea ointment

was significantly more

effective (p0.0167) in

debriding at all 3 time

points

-Reduction in area of

nonviable tissue covering

wounds over time was

significantly greater

(p0.0167) for papain-urea

at all 3 evaluations

-Visual scores showed that

granulation was

significantly (p0.0167)

greater for papain-urea

- Neither were associated

with pain or discomfort

-Small sample size,

therefore strong

scientific conclusions

cannot be made

-Author’s initial intent

was to perform a

double-blind study, but

the physical differences

in ointments precluded

such

- ? 4 Stage II PrUs were

included


84


Length of Follow-up

Results Limitations

repositioned: q 2 hours using pillows &

foam wedges whenever possible

-Written turning schedules & diaries

were kept on all subjects

-1 investigator or CSC at each site

performed all evaluations

-If infected, infection had to be

resolved prior to enrollment

Induration

Edema

Erythema

Amount granulation

Amount re-epithelialization

(using surface area wound

tracings)

Wounds were treatment. Until

complete debridement or 4 weeks.

Bale S, Banks V, Haglestein S,

Harding KG. A comparison of

two amorphous hydrogels in

the debridement of pressure

sores. J Wound Care.

1998;7(2):65-8.

Evidence Level = II

Randomized,

controlled, blinded

trial

N=50 subjects (hospital

& community); 38

completed study

Inclusion:

Stage II-IV

(NPUAP Staging,

1989) “with

necrosis”

Exclusion:

Ulcers >8 cm

diameter

Immunosuppres

sion

Pregnant or

nursing

Within another

clinical trial

within <1 month

prior

If already participated

in this trial

Group A (Sterigel) (n=21)

∆ Daily

Cover with Telfa & Tegaderm

Group B (Intrasite) (n= 69)

∆ Daily

Cover with Telfa & Tegaderm

Duration, max 4 weeks or until wound

debrided, whichever sooner

-Full assessment by nurse caring

for subject q 7 days until end of

study day 28

-Necrosis classified by 1 of 4

categories:

1. Black

2. Green

3. Yellow

4. Red

-Photos & tracings taken @ each

assessment

-Effect of dressing on surrounding

skin measured by study nurse (5

options; dry/flaky to macerated)

-Wound odor measured by

selecting; none, intermittent,

continuous

-Pain measured by selecting: none,

intermittent, continuous

-Pain on removal of dressing; pain,

slight pain & severe pain

-Photos submitted for

computerized wound analysis,

undertaken by an independent

assessor who was blind to

treatment groups to confirm or

reject subjective nursing

assessments

No statistical significance

between groups, in:

Time to debride

Pain experienced

Pain upon dressing

removal

Odor

Development of

maceration

-Stage II ulcers included

-Small sample size

(???Staging accuracy)

-Evaluation tool not fully

described

-??Granulation classified

as necrosis

-Large # of subject

withdrawals 2 to

general ill health –

-? Standardization of

photos & tracings

Burgos A, Gimenez, J,

Moreno, E, Lanberto, E, et al.

Cost, efficacy, efficiency and

tolerability of collagenase

Multi-center,

randomized, non-

blind, parallel study

conducted at seven

Thirty-seven patients

were randomized using

a computer-generated

randomized list into

Topical enzyme vs.

Hydrocolloid

Topical enzyme Collagenase (Iruxol):

Ulcer assessments were

performed by direct & indirect

methods:

37 evaluable patients were

included in the study;

77.8% had albumin levels

of ≤ 3.5 g/dl

No discussion on

debridement

outcomes

No discussion on


85


Length of Follow-up

Results Limitations

ointment versus hydrocolloid

occlusive dressing in the

treatment of pressure ulcers:

a comparative, randomized,

multicentre study. Clin Drug

Invest. 2000;19(5):357-365.

Evidence Level = II

hospitals in Spain blocks of 4 patients to

receive either:

1. Collagenase

ointment

(Iruxol)

2. Hydrocolloid

(Varhesive)

Inclusion:

Patients aged 55

years or older

Stage III PrUs (to a

depth of

subcutaneous

tissue) for less

than one year

duration

Exclusion:

End-stage organ

disease

Localized or

systemic s/s of

infection (fever,

local erythema,

regional lymph

node swelling)

Hypersensitivity to

collagenase

(n=18)

-Applied once daily in a 1 to 2 mm thick

layer to the wound bed

Hydrocolloid (Varihesive): (n-19)

-Ulcers were cleansed with sterile NS

-HCD applied and ∆ed q 3rd day, sooner

if leaking

-To ulcers that were deep or with large

amounts of drainage, Varihesive paste

was applied and the ulcer was covered

with a HCD

Treatment was continued for 12 weeks

or until complete ulcer healing,

whichever occurred first

At baseline, all subjects received:

-History & physicals

-Arnell scoring (not defined)

-Blood testing (hematological &

biochemical parameters, including

serum albumin)

-Exudate samples were taken for

microbiological studies

Direct Measurements:

-Ulcer perimeter outline was

traced onto a labeled transparent

acetate film

The surface area was calculated

using planimetry by an observer

blind to therapeutic assignment

Indirect Measurement:

-An identification label was placed

at each ulcer margin and ulcers

were photographed according to a

standardized method at 50 cm

from the focus and the contour of

each ulcer was transferred to a

transparent acetate

All wound examinations were

performed weekly & consisted of:

-Ulcer photography

-Assessment of ulcer are (1

outcome measure)

-Adverse reactions to study

treatment

-Evaluation of 4 ulcer

characteristics (pain, % granulation

tissue, exudates and odor all

measured on a 5 point scale)

Cost associated with each study

treatment was determined by the

cost of the study products,

ancillary supplies and labor costs

of nursing staff

-Eight (44.4%) and six

(31.6%) patients in the

collagenase and HCD

groups respectively,

discontinued the study

prematurely,

Reasons for

discontinuation included,

death due to unrelated

cause (n=4), hospital

discharge (n=4) and

transfer to another

hospital (n=3), protocol

violation (n=2),

deterioration of general

patient condition (n=1)

(and for the HCD arm lack

of efficacy (n=1)

There was a stat significant

difference in those who

discontinued early and

those who completed the

12 week course, with the

former group exhibiting a

mean ulcer area increase

and the later a decrease

(p=0.023) Of those in the

collagenase group who left

the study prematurely

there was a statistically

significant decrease in

mean ulcer area from the

HCD group who left early

(p=0.021)

Given that subjects who

discontinued treatment

early introduced bias, an

intent-to-treat analysis

was performed

Differences in the direct

and indirect ulcer

measurement methods

standardization of

care as it pertains

to pressure

redistribution and

nutritional

interventions

Small sample size

No blinding

Arnell scoring not

defined


86


Length of Follow-up

Results Limitations

were not statistically

significant

-After 12 weeks 83.3% of

subjects receiving

collagenase exhibited a

reduction in ulcer area, vs.

73.7% of those treated

with HCD, the difference

did not reach stat

significance

-Complete healing was

achieved in six (16.2%) of

patients, 3 in each

treatment arm

-Efficacy analyses reported

an ulcer reduction of

44.2% in the collagenase

group and 27.9% in the

HCD group

-Cost analyses between

the two group was stat

significant (p0.0001)

-Efficacy analyses showed

no stat significant

differences between the

groups

-Pain intensity was stat

significantly decreased in

those receiving

collagenase (p=0.001)

-Granulation tissue ↑

(p0.0005) & exudates ↓

(p 0.0005) in both

treatment groups

-1 subject in the

collagenase group

developed dermatitis and

1 in the HCD presented

with ↑ erythema and

exudates

-Treatment efficacy cost

tended to be lower in the

collagenase group than in

the HCD

-Tolerability of both


87


Length of Follow-up

Results Limitations

treatments was good

Study was not able to

detect stat significant

differences between the

two treatments, but the

collagenase exhibited a

trend toward greater

efficacy and efficiency

Burke DT, Ho CH, Saucier MA,

Stewart G. Effects of

hydrotherapy on pressure

ulcer healing. Am J Phys Med

Rehabil. 1998;77(5):394-8.

Evidence Level = II

Randomized

controlled trial

N=18 subjects with 42

PrUs

Inclusion:

Hospitalized in-

patients

Stage II or IV

Exclusion:

Cardiac

arrhythmias

Use of life-

monitoring

equipment

Group 1 (Control) Non-whirlpool(n=18)

Mechanical debridement

FlexiCair Bed (sacral, ischial or

trochanteric PrU)

Group 2 (Treatment) Whirlpool: (n=

24)

Same as Group 1

20 minutes min of whirlpool

therapy 1x daily (96-98 F)

Instrument(s): not stated

Items: wound size (T-test to

compare mean ∆ in wound size

across groups)

Group 1 (Non-whirlpool):

Improved-n=5 (28%

of patients)

No ∆- n=2 (11% of

patients)

Deterioration- n= 11

(61% of patients)

Group 2 (Whirlpool):

Improved-n=14 (58%

of patients)

No ∆- n=1 (4% of

patients)

Deterioration- n= 9

(38% of patients)

-Wound bacterial count

& effect of bacterial

load on reduction of

wound size were not

measured

Subjects should have

been randomized, not

the ulcers; possible

confounding bias

Colin D, Kurring P, Quinlan D,

Yvon C. Managing sloughy

pressure sores. J Wound Care.

1996;5(10):444-6.

Evidence Level = II

Open, multicenter,

multinational,

parallel group,

prospective

randomized, study

N=135 (120 patients

completed the study); 6

trial centers

Inclusion:

PrUs containing

slough

Pressure ulcers

Grades I-IV

Exclusion:

Not stated

When a patient

presented with more

than one PrU, only the

largest ulcer was

assessed as part of this

study; other ulcers were

Patients were randomly allocated to

one of two treatment groups:

Hydrogel (Intrasite Gel) & secondary

dressing Melain (n=67)

Dextranomer (Debrisan Paste) paste &

secondary dressing Melain (n= 68)

-Wound assessments and an

evaluation of dressing characteristics

were performed q 7 days

-Wound photographs were taken at

the initial and final assessments

-Data on patient comfort was assessed

subjectively, as was ease of application

(Likert scale)

-Data on ease of application was

collected

1 outcome measure:

- % reduction in the area of non-

viable tissue during the 21 day

period (measured by Wilcoxon

Rank Sum Test)

2 outcome measure:

-Median % reduction in wound

surface area

-Study duration continued until

the wound was fully debrided or

on completion of 21 days of

treatment, whichever was earlier

Outcome analyses were

performed on the

intention-to- treat

population (this includes

all patients completing at

least on follow-up visit

(135 patients enrolled, 120

completed the study)

At day 21, the median %

reduction in non-viable

tissue was 74% in the

amorphous hydrogel

group compared with 62%

in the dextranomer paste

group, which was not

statistically significant

(p=0.20).

-At day 21 the median

reduction in PrU area was

-Inclusion and exclusion

criteria not well defined

-Question

appropriateness of

including Grade I and II

PrUs included

-Dressing change

procedures, frequency

not described

-Uncertain if

standardization of

overall PrU

management was

implemented, not

described

-Practice setting of

treatment not described

-No blinding

- Short follow-up

timeframe


88


Length of Follow-up

Results Limitations

treated with the same

randomized dressing if

considered clinically

appropriate by the

investigator

-Both dressing types were applied and

changed according to manufacturer’s

instructions. The secondary dressing

used for both treatment groups was a

non-occlusive absorbent dressing

(Melolin)


(p=0.03); 35% reduction in

hydrogel treated PrU

compared to 7%in the

dextranomer treated

group

- 8 (12%) of Hydrogel

treated ulcers

deteriorated and 13 (19%)

of dextranomer treated

ulcer deteriorated

-The only reported

dressing related adverse

event was in the

dextranomer treated

group and that was pain

with dressing application

-Assessments at days 7,14

& 21 found the amorphous

hydrogel to be easier to

apply and remove than the

dextranomer paste and

was associated with less

pain

Patient outcomes:

Hydrogel (n=67)

-53 (79%) completed

study; 14 (21%) were

withdrawn; 1 Adverse

incident, 2 died and 11 lost

to follow-up

Dextranomer paste (n=68)

-43 (63%) ) completed

study; 25 (37%) were

withdrawn; 4 Adverse

events, 2 died and 19 were

lost to follow-up

Martin SJ, Corrado OJ, Kay EA.

Enzymatic debridement for

necrotic wounds. J Wound

Randomized,

double-blind,

controlled trial

N=17 subjects (21 PrUs)

Inclusion:

Grade IV PrU

Group A; (n=11)

Enzyme in KY Jelly

Administered 1x daily

-Independently assessed & photo

daily

-Data form used (not described)

Group A:

-Mean (11.8 days); SD 2.9

Enzyme in KY Jelly Group

-Small sample size

-Not powered

-Grade IV stated, but


89


Length of Follow-up

Results Limitations

Care. 1996;5(7):310-1.

Evidence Level = II

If > 1 ulcer, each

entered

separately

Exclusion:

Treatment with

Streptokinase

/streptodornase

(Enzyme) within 4

weeks

Terminally ill

Unable to consent

Covered by thin film dressing

Group B: (n= 10)

Hydrogel (KY Jelly)

1 x daily

Thin film

Double-blind (Treatment agent in

syringes)

-Mean, range & SD for eschar

removal calculated for Groups

A&B

-Endpoint was eschar removal

Group B:

-Mean (8.1 days); SD 1.8,

KY Jelly alone


between groups

described as ulcers with

eschar

-Only stats are (mean,

SD, range)

-Data collection tool not

described

Matzen S, Peschardt A,

Alsbjorn B. A new amorphous

hydrocolloid for the

treatment of pressure sores:

a randomised controlled

study. Scand J Plast Reconstr

Surg Hand Surg.

1999;33(1):13-5.

Evidence Level= II

Also in Table 9 Dressings

Randomized,

controlled study

N=32 patients enrolled

(12 patients completed

the study; 9 patients in

the hydrogel arm & 11

in the control arm

withdrew) (Outpatient

clinic in Copenhagen)

Inclusion:

Stage III & IV

PrUs

Non-infected

Sacral &

trochanteric

Exclusion:

Location other

than sacral or

trochanteric

Patients with

diseases or

taking drugs

known to impair

healing

Patients were randomly allocated to

one of two treatment groups after an

initial sharp debridement in the

outpatient clinic.

(Control) Saline moistened gauze

(n=15):

-Ulcer cleansed daily (agent not

specified)

-Dressing ∆ daily

-Covered with Comfeel Transparent

Dressing (Coloplast)

(Treatment) Amorphous hydrocolloid

(Coloplast A/S, Denmark) (n= 17):

-Ulcer cleansed daily (agent not

specified)

-Dressing ∆ daily

-Covered with Comfeel Transparent

Dressing (Coloplast)

-Once weekly the healing of the ulcers

was estimated by the same

investigator measuring the amount of

water needed to fill the cavity

-The need for debridement was

evaluated and was performed as

needed

1 outcome measure was to

compare the effect of a new

amorphous hydrocolloid with that

of conventional treatment on PrU

healing time

2 outcome measure was to

compare the frequency of

required PrU debridements in the

two treatment groups

Patients were followed for 12

weeks or until the ulcer healed in

their home environment

-Relative volumes (from

the initial 100%) of

hydrogel treated wounds

were significantly less (26

± 20%, p< 0.02) than those

of saline treated wounds

(64 16%) in the last week

of the study

-The saline treated

wounds required more

frequent weekly

debridements than the

hydrogel treated wounds

(21% compared with 7% of

all weekly dressings, p

0.03)

- During the period of the

study 5 of the hydrogel-

treated ulcers healed,

whereas none in the

control arm healed

-6 of the patients in the

saline gauze group

developed necrotic tissue

with infection and

therefore required surgical

revision after which they

were no longer included in

the study

-In general all dressing had

to be ∆ed ever day with no

significant differences in

leakage of exudates from

-In the exclusion patient

medical history

exclusionary variables

not described

-No blinding

-Small sample size

-High withdrawal rate,

further limiting sample

size and generalizability

of findings

-No discussion of

standardization of any

other components of

treatment

-Estimated

measurement of volume

by filling with water

-No discussion of

randomization method


90


Length of Follow-up

Results Limitations

the wounds

- No statistically significant

difference between the

two treatment arms

related to odor, pain

during treatment, comfort

during use, nor length of

time dressings required

(days)

-(20 patients in total

withdrew); 9 patients in

the hydrogel group

withdrew (because of

other illness (n=5); death

(n=2); missing

appointment (n=1) and a

wish to discontinue

participation (n=1)); 11

patients in the control arm

withdrew; because of

insufficient effect of

treatment (n=6); other

illness (n=3); death (n=1);

wish to discontinue

participation (n=1)

-Results of intent to treat

population was analyzed

-Data was skewed and

therefore were assessed

by the non-parametric

Mann-Whitney test.

Differences were accepted

as significant if the

probability was less than

0.05

Muller E, van Leen MW,

Bergemann R. Economic

evaluation of collagenase-

containing ointment and

hydrocolloid dressing in the

treatment of pressure ulcers.

Pharmacoeconomics.

2001;19(12):1209-16.

Prospective,

Randomized, trial

N=23 eligible female

subjects (orthopedic hip

surgery patients in a

Netherlands hospital);

Subject age range 65-79

years

Inclusion:

Stage IV PrU on

-After autolysis led to release of

necrotic tissue, then surgical

debridement was performed to

achieve a clean wound bed

-Following debridement, subjects were

randomized to either the collagenase

or HCD group

1 outcome parameter:

-Complete healing

2 outcome parameter:

-Weeks required to achieve

healing

-11 of 12 (91.7%) of

subjects achieved

complete epithelialization

with collagenase; versus 7

of 11 (63.6%) in the

hydrocolloid group

(p0.005)

-Time to achieve healing

-All subjects female

-Small sample size

-Subjects were all

surgically debrided prior

to enrollment, outcome

measures examined

healing times not

debridement


91


Length of Follow-up

Results Limitations

Evidence Level = II

(Examined healing and cost,

not debridement)

the heel

Exclusion:

Life expectancy

6 months

Collagenase-containing ointment

(Novuxol) (n=12)

Cleanse with NS

Once daily ointment

application

Cover with paraffin gauze

(Jelonet)

Absorbent gauze

Hydrocolloid (Duoderm) (n= 12)

∆ twice per week

Treatment & clinical evaluation

continued until total epithelialization

was achieved

-Formation of necrotic tissue was

considered treatment failure &

resulted in the patient receiving a

different treatment regime. The ulcer

would be debrided again and treated

with an alginate dressing (Kaltostat) or

a combination of Kaltostat &

collagenase

Treatment efficacy was

determined by size & depth of the

ulcer, signs of inflammation,

formation of granulation and

epithelialization

-MD performed clinical

assessments weekly including

photography

was 6-12 weeks (mean 10

weeks) in the collagenase

arm & 11-16 weeks (mean

14 weeks)in the HCD arm

(p0.005)

-HCD reported to be 51%

more costly than

collagenase per

successfully treated

patient

-Number of treatment

failures not discussed

Parnell LKS, Ciufi B, Gokoo CF.

Preliminary use of a hydrogel

containing enzymes in the

treatment of stage II and

stage III pressure ulcers.

Ostomy Wound Manage.

2005;51(8):50-60.


Prospective study 10 nursing home

residents with Stage II

(n=3) and Stage III (n=7)

PrUs that had failed to

heal during a 3-month

period.

-Ulcers were cleansed daily with NS

using aseptic technique. -Following

cleansing, the wound bed was blotted

dry with gauze, a thin layer of hydrogel

(approximately ¼ inch thick) was

applied &

covered with a 2 gauze dressing

-Wounds were dressed 1 x/day unless

soiled or displaced.

-All other regimens (e.g., turning,

bathing, and similar activities) were

performed per each facility’s policies

and procedures (unchanged from the

previous 3 months).

-1 week before & 1 week before

the last week of the study, the

following lab tests were

performed: blood serum albumin,

serum creatinine, serum

transferrin, Hgb, TP, TLC and WBC.

-All research data & comments

were captured on NCR CRFs.

-Healing was the 1 endpoint &

was based on re-epithelialization

as determined by area

measurement & clinical

assessment. -Wound length,

width, depth, volume, area, &

perimeter were determined using

Computerized Imaging System

(CIS) (DynaMedics Corporation,

Keller, Tex).

-7 subjects (Stage II=3;

Stage III=4) completed the

study. All Stage II & 2 of

the Stage III ulcers healed;

4 Stage II were categorized

as healing (≥ 60%

improvement) after 12

weeks of care.

-No dressing related

adverse events occurred

-Subject product

acceptance, including

comfort was high.

-The dressing cost is

reasonable & the only 2

dressing used was gauze.

-Very small sample size

(n=7), not generalizable

-No comparative group

-Question inappropriate

inclusion of Stage II

ulcers

-Additional studies

could be performed

with film or foam to

determine if wear

time could be achieved;

thereby dressing &

labor costs.

-Additional studies

designed to define the

possible contribution of

endopeptidase enzymes

in wound healing are


92


Length of Follow-up

Results Limitations

warranted.

-Pre-established scales

developed specifically

for this evaluation were

used in this instrument,

but formal reliability &

validity testing was not

performed.

-Retrospective review of

the medical chart for

the 3 month historical

control presents

limitations.

-Although wound

measurements,

treatment regimes, &

nursing notes provided

useful information for

control data

inexpensively, the

historical perspective

lacks direct comparison

of placebo & test

articles between

subjects

Pullen R, Popp R, Volkers P,

Füsgen I. Prospective

randomized double-blind

study of the wound-debriding

effects of collagenase and

fibrinolysin/deoxyribonucleas

e in pressure ulcers. Age

Ageing. 2002;31(2):126-30.

Evidence Level = II

Prospective,

randomized,

double-blind

N=135 subjects

Inclusion:

Seiler Stage 2,3 or

4 with fibrinous

&/or necrotic

slough

If several PrUs,

worst one chosen

Between 2-14.5

cm diameter (to

allow photo

assessment)

Exclusion:

Drug or ETOH

dependence

h/o

hypersensitivity to

collagenase or

F/DNAse

Planned co-

Collagenase (n=66)

2x/day

Covered with gauze

Continued until complete

debridement or max of 4 weeks

F/DNAse: (n= 69)

2x/day

Covered with gauze

Continued until complete

debridement or max of 4 weeks

-12 Baseline photos taken

-Photo q 4days (standardized

distance & flash)

-Scale with color range placed by

each lesion

1º Efficacy:

-Δ in area of necrosis from

baseline to end (or premature

withdrawal)

-Assessed by 2 independent

blinded dermatologists by 13x18

cm photos, classified into 5

categories:

1. Clear ↑ (≥ 100%)

2. ↑ (≥ 30%)

3. No ∆

4. ↓ (≥ 25%)

5. Clear ↓ (≥ 50%)

Efficacy objective: (subjective by 2

independent MDs)

-Of the “per-protocol

population” (n=78), no stat

sign difference between

arms (p=0.164)

-From the 121 patients

“(intention to treatment

pop”) ↓ in necrotic tissue

reported for 37 (61.7%) for

collagenase, compared

with 35 (57.4%) of those

with F/DNAse no stat sign

difference


between groups

-Physicians selected

support surface &

turning intervals ( no

standardization)

-Reliability of measures

-Potential bias


93


Length of Follow-up

Results Limitations

medication with

(antiseptics,

antibiotics,

occlusive dressing,

hydrogels or

HCDs)

Location not

permitting parallel

positioning of

reference scale

Subject age range (55-

94 years)

1. Environment of wound

2. Wound margins

3. Wound depth

4. Pocketing

5. Area

Wound healing

Sherman RA. Maggot versus

conservative debridement

therapy for the treatment of

pressure ulcers. Wound

Repair Regen.

2002;10(4):208-14.


Clinical series,

retrospective

analysis

Convenience sample

(N=67 subjects; with 92

PrUs); initially cohort of

103 subjects

Inclusion:

Wounds with

complex non-

planar topography

Wounds

photographed

without scale

markers

f/u 2 weeks

Exclusion:

Underlying

osteomyelitis

Rapidly advancing

infection

Maggot treatment

Conventional Treatment

Photo planography of:

1. Dimensions: l, w,

circumference & surface area

2. Outcomes

-Relative & absolute ∆ in surface

area

-% necrotic tissue vs. granulation

tissue

-Complete debridement

-Complete closure

--Calculated by : ∆ sA (t2-1)

Mean circumference (t2-1)

T1= initial observation

T2=final observation

% Necrotic wounds

debrided (MDT 80%;

vs. Conventional

48%)

Weeks to 50%

debridement (MDT

1.4 vs. Conventional

4)

Weeks to 100%

debridement (MDT 8

vs. 17)

∆ in SA/week (MDT -

1.6 vs. Conventional

+0.3)

∆ in % granulation

13% vs. 3.3%)

Average time to

complete healing

(MDT 12 weeks vs.

13.4 weeks)

% Healed (MDT 39% vs.

21%)

Weak

methodology

Extremely limited

access to

treatment

Wound size larger

in MDT arm

(p=0.035)

MDT patient

characteristics (SCI

(p0.05)

DM (P0.05)

(favored

Conventional

treatment)

No description of

Conventional

treatment.


Length of Follow-up

Results Limitations

Granick MS, Posnett J, Jacoby

M, Noruthun S, Ganchi PA,

Retrospective with

historical control

N=62 patients (from a

Plastic Surgery practice

-Retrospective chart review of those

patients having undergone:

-Evaluation of efficacy, safety and

economic impact of using the

A multiple regression

model was fitted with

-Retrospective study

with historical


94


Length of Follow-up

Results Limitations

Datiashvili RO. Efficacy and

cost-effectiveness of a high-

powered parallel waterjet for

wound debridement. Wound

Repair Regen.

2006;14(4):394-7.

the records of all 40

patients having

undergone excisional

debridement (ICD 9-CM

code 86.22) in 2003 with

Versajet were compared

with a control group

treated with

conventional

debridement in 2002)

Inclusion:

Patients whose

wounds were

treated with

Versajet by the

Plastic Surgery

Department in

2003

Patients whose

wounds were

treated with

conventional

sharp

debridement

(scalpel, curette

and electro

cautery) by the

senior surgeon in

2002

Acute and

chronic wounds

Exclusion:

Wounds treated with

debridement methods

other than scalpel,

curette, electro cautery

or Versajet

Versajet Study Group (n=40))compared

to Conventional sharp debridement

Control Group (n= 22)

Versajet compared to conventional

sharp debridement. Patient’s

Medical Records which were coded

as excisional debridement where

Versajet was utilized in 2003 was

compared with patients similarly

coded as having undergone

conventional sharp debridement in

2002

covariates for patient age,

wound area and treatment

group to determine

whether there was a

difference in debridement

time. A logistic regression

model was fitted to the

number of procedures

with covariates for patient

age, wound area, and

treatment group to assess

the difference between

groups in the odds of

having a lower number of

procedures relative to a

higher number of

procedures

-The patient samplings

were well matched in

terms of gender, age,

admitting diagnosis and

wound type.. But the

median wound area was

significantly larger in the

control group (p=0.016)

-The mean number of

surgical procedures was

significantly less with

Versajet (p=0.0002).

-The odds of having a

lower number of

procedures were

significantly greater with

Versajet than with

conventional debridement

(p=0.010)

-Wounds treated with

Versajet were Acute

(51%), chronic (49%), PrUs

(30%)

-The conventional sharp

debridement population

consisted of acute (36%),

unmatched controls

-Versajet 51% acute

wounds & 49% chronic;

Conventional treatment

36% acute & 64%

chronic

-Median wound area

was 88 cm2 in Versajet

Group compared to 213

cm2 in the Conventional

Group (p=0.016)


95


Length of Follow-up

Results Limitations

chronic (64%) and PrUs

(32%)

Mosti G, Mattaliano, V.l. The

debridement of chronic leg

ulcers by means of a new,

fluidjet-based device.

Wounds. 2006;18(8):227-337.

(Not specified by

authors)

Non-randomized

trial with

convenience

sampling

N= 469 hospitalized


vascular leg ulcers in

Italy; 142 treated with

Versajet Hydrosurgery

System & 327 treated

with moist dressings

(Control)

Inclusion:

Chronic vascular

leg ulcer (e.g.

Arterial, venous,

mixed etiology,

vasculitis, post-

traumatic,

iatrogenic,

microangiopathy)

> 70% of ulcer

surface covered

by necrotic tissue

or thick fibrin

slough with or

without exudates

Presence of

hypertrophic

granulation tissue

Exposed tendon or bone

Treatment Group: (n=142)

Hydrosurgical debridement

Performed daily or every other

day

Moist dressings also used (type

not specific)

Control Group: (n= 327)

Moist dressings (hydrogel and HCD

dressings)

Outcomes Measured:

-Time to complete debridement

-Effect on bacterial burden

-Procedure-related pain with Visual

Analogue Scale

-Bleeding complications

Patients were followed until

wound closure

The effects of the 2 debriding

methods were followed in 3

patients who had large bilateral

ulcers (1 ulcer treated with

Hydrosurgical device & the other

the control). Before treatment &

after 24 & 48 hours of treatment

2ml of exudates were collected

and the levels of IL-I, IL-6, TNF-,

ICAM-1, VCAM-1, MMP-9, IL-10

were measured

Hydrosurgical Group:

-In 108 patients, 1

operative procedure was

sufficient to achieve an

adequately debrided

wound bed; 2 procedures

were required in 27 cases

& 3 procedures in 7 cases.

-Average time to achieve

complete ulcer

debridement wound bed

was 1.3 0.6 days,

compared to 4.3 3.9

days with the control

group

Hospitalization “reduced”

by a mean of 3 days

Bacterial burden ↓from

106 to 103

-MD rated the patient’s

pain levels VAS 4.3 ±. 9

;(87.8% of patients found

the pain to be comparable

to that of cleansing with

NS and gauze); only 10.5%

considered the procedure

painful and required local

anesthesia

-Healing rate 82%

-Minor bleeding stopped

spontaneously

-Patient satisfaction score

2.8 0.1

Control Group:

-VAS score rated by MD or

Nurse 5.3 2.1; none of

the patients required

general, nor local

anesthesia

- Minor bleeding stopped

-Healing rate 88%

-Non-randomized

-? MD & Nurses rated

pain for the patients

-Pre & post treatment

bacterial levels not

provided for control

arm

-No statistical

comparisons


96


Length of Follow-up

Results Limitations

Patient satisfaction score

2.8 0.1

Steed D, Donohoe D, Webster

M, Lindsley L. Effect of

extensive debridement and

treatment on the healing of

diabetic foot ulcers. J Am Coll

Surg. 1996;183:61-4.

Randomized,

prospective,

double-blind,

multi-center trial

N=118 subjects with

diabetic neuropathic foot

ulcers (10 study centers)

Inclusion:

Diabetic

neuropathic foot

ulcers

Free of infection

on physical exam

& on plain

roentenograms

of the foot

Ulcers secondary

to neuropathy

Adequate arterial

blood supply

(TcPO2 of 30 mm

Hg

Ulcer present for

at least 8 weeks

without healing

Exclusion:

Poor diabetes

control

Renal failure

Abnormal liver

function

Exposed bone

-All patients received aggressive

debridement prior to randomization

-Repeated debridements of callus and

necrotic tissue were performed as

clinically indicated

-Any areas of undermining of skin

edges were unroofed to prevent

collection of bacteria & pus in the

wound

-Any clefts of granulation tissue were

saucerized for the same reason

Recombinant human platelet-derived

growth factor (rhPDGF) (n=)

Placebo (Vehicle-Hydrogel) (n= )

Duration of treatment was until ulcer

completely healed or up to 20 weeks

-The influence of debridement was

evaluated by reviewing the records

of office visits where debridements

were performed

-Forty-eight percent of

subjects treated with rh

PDGF healed compared to

25% those who received

placebo (p=0.01)

-The mean percentage of

of office visits where

debridements were

performed was

comparable for the two

treatment groups: 46.8

percent (rhPDGF) and 48.0

percent (placebo)

-In general a lower rate of

healing was found in those

centers that performed

less frequent

debridements

Williams D, Enoch S, Miller D,

Harris K, Price P, Harding KG.

Effect of sharp debridement

using curette on recalcitrant

nonhealing venous leg ulcers:

a concurrently controlled,

prospective cohort study.

Wound Repair Regen.

2005;13(2):131-7.

Concurrently,

controlled ,

prospective

parallel pilot study

(nonrandomized)

N=53 patients with 55

chronic venous leg ulcers

(CVLU)referred to a

specialist wound center

in Cardiff, UK

-51 patients with 533

CVLU completed the

study

-Patients were recruited

from the 3 weekly clinics

in the study center

-Patients in the Study

group were selected by

Debridement Study Group (n=24

patients with 26 CVLU))

Debridement was performed

by a single operator, using a

sharp circular curette (size 4 or

7) avoiding the sensitive ulcer

edges and was aimed at

removing slough, nonviable

tissue, and any avascular

fibrous tissue down to the

vascular base

All patients received topical

anesthesia & the procedure

- -Ulcer measurements were taken

at 4 weeks before debridement, at

the time of debridement, and 4

and 20 weeks post-debridement.

-All patients were followed up to a

minimum of 20 weeks after

debridement

-Any complications were

documented

-Summary statistics were used to

describe the sample at baseline

and comparisons were made using

Chi Square and Student’s t-test

-2 patients from the

debridement group had to

be excluded ; 1 secondary

to new onset dx of

leukemia and a second

patient who did not

adhere with compression

A total of 24 patients (26

ulcers) from the study

group and 27 from the

control group were

included in the analysis (1

patient contributed two

-Authors noted that this

is an ethically difficult

area to conduct

randomized controlled

clinical trials, and as

such, a nonrandomized

method was used.

-Secondary to a less

rigorous design, the

groups are less

homogenous than

expected and thus may

explain some of the


97


Length of Follow-up

Results Limitations

virtue of their wound bed

characteristics

-Patients in the Control

group whose wounds

were not debrided, were

selected from the patient

attendance list using

systematic sampling &

had wound beds with 15-

20% granulation tissue,

but no slough nor

nonviable tissue

Inclusion:

Ulcers > 3

months duration

Ulcers refractory

to conventional

treatment

Ulcers with

absent

granulation tissue

or the presence

of nonviable

tissue

Ulcers containing

yellow/white

slough with or

without

fibrous/scar

tissue

Ulcers with

copious amount

of exudates

Venous disease

confirmed

clinically and/or

by color flow

duplex imaging

(CDI)

No evidence of

peripheral

vascular disease,

either on clinical

was abandoned if the patient

experienced pain or

discomfort, a topical anesthetic

cream was applied to the

wound for 30-45 minutes at

the patient’s repeat visit to

complete debridement

All but one patient had a single

episode of debridement

A calcium alginate (Kaltostat)

was applied to control blood

loss after debridement

Simple analgesics were

prescribed for pain relief

Non- or low adherence dressing

were used

4-layer bandage system was most

commonly used, although short

stretch bandages and tubular

bandages were also used if

patients could not tolerate the 4-

layer

Non-debridement Control Group (n=

27)

Non- or low adherence dressing

were used

4-layer bandage system was most

commonly used, although short

stretch bandages and tubular

bandages were also used if

patients could not tolerate the 4-

layer

-Mean ulcer surface area and rate

of change were calculated using

mixed ANOVA, with post hoc

analysis assuming non-

homogenous variance. Two tailed

alpha was set at 0.05.

ulcers (different limbs) on

separate occasions to both

the study & control groups

-The reduction in MSA

between groups over the

entire 20 week study

period did not achieve

statistical significance ,

sharp debridement was

clearly effective in

initiating the healing

process in the study group

-At 4 weeks post-

debridement, the study

ulcers showed a 6 cm2

reduction in the MSA vs. a

1cm2 reduction in controls

(p=0.02).

-Infection rates in the

study group 4 weeks after

debridement were less

than the control group,

not statistically significant

variability in response.

-The Study group at

baseline had no

granulation tissue and

presented with slough,

while the control at

baseline had wound

beds with 15-20%

granulation and no

slough, nor non-viable

tissue


98


Length of Follow-up

Results Limitations

examination or

on CDI

Exclusion:

ABPI < 0.8

Patients with

small (< 2.5 cm2 )

or very large

(>100 cm2 )

Ulcers which are

clinically infected

with or without

microbiological

confirmation

Ulcers associated

with mixed

etiology (e.g.

Arterio-venous

ulcers)

Ulcers secondary

to systemic

causes such as

diabetes mellitus,

connective tissue

diseases (e.g.

Rheumatoid

arthritis) and

metabolic

diseases

Suspicion of

malignancy

within the ulcer

Patients with concurrent

unrelated malignancy


99

Table 8. Dressings References Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Amione P, Ricci E, Topo F, Izzo

L, Pirovano R, Rega V, et al.

Comparison of Allevyn

Adhesive and Biatain

Adhesive in the management

of pressure ulcers. J Wound

Care. 2005;14(8 (Print)):365-

70.

Prospective

multicenter study

to examine the

delamination of

dressings (defined

as dressing falling

apart during wear

or removal or

presence of

dressing residue in

ulcer)

32 subjects with grade II

or III PrU randomized to

either Allevyn or Biatain

adhesive dressing

83% of patients with Biatain

dressing had delamination

compared with 14% of Allevyn

Allevyn also better in handing

exudate, comfort, ease of

application, conformability and

removal

Taken from abstract

Brown GS. Reporting

outcomes for stage IV

pressure ulcer healing: a

proposal. Adv Skin Wound

Care. 2000;13(6):277-83.

Retro 9 patients with 10 pelvic

stage IV PRU

Mean age 75

All male

NS gauze vs. Ca alginate followed by

hydrocolloid or foam

Eschar was sharply débrided and

slough was removed by WTD

Weekly measurement of wound

length x width in cm

Small ulcers (18-24 cm) healed in

82-119 days with an average daily

reduction of 0.199 – 0.244 cm2

Medium ulcers (36- 51 cm) healed

in 91-176 days with an average

daily reduction of 0.264 -0.386 cm2

Large ulcers (80.5 – 117 cm)

healed in 102-233 days with an

average daily reduction of 0.502 to

0.789 cm2

End of treatment was

epithelialization

Initial wound size

increased followed by

nonlinear reduction in

wound size

Median albumin rose from

3.10 to 3.4 with healed

wounds, Hgb rose from

10.4 to 11.8 with healing

Mobility changed from

bedfast or chair with max

assist to out of bed with

max assist, w/c with min

max and ambulatory

Subjects followed to full

healing

No discussion or results

on the difference in

healing based upon

topical treatment

Brown-Etris M, Milne C,

Orsted H, Gates JL, Netsch D,

Punchello M, et al. A

prospective, randomized,

multisite clinical evaluation of

a transparent absorbent

acrylic dressing and a

hydrocolloid dressing in the

management of Stage II and

shallow Stage III pressure

ulcers. Adv Skin Wound Care.

2008;21(4):169-74.

Evidence Level = I

Prospective

randomized

comparative

multisite clinical

evaluation.

A total of 72 patients

with stage II and shallow

stage III, minimally

draining pressure ulcer

were enrolled in the

study. 35 patients

received the Tegaderm

absorbent Clear Acrylic

Dressing (TAAD), and 37

received the hydrocolloid

dressing.

Patients were randomized to receive

either the TAAD or HD for the

treatment the pressure ulcer. Dressing

size was optimally matched to the

needs of the wound.

Wounds and dressings performance

were assessed on a weekly basis.

Dressing performance

assessments and patient comfort

were rated.

Dressing wear time was observed.

Wound healing was defined as

closer of the epidermis.

Patients were followed for up for a

maximum of 56 days or until their

ulcer healed.

The majority of

investigators assessment

favored the TAAD.

Consideration given

included the ability to

center dressings over the

ulcer (p = .005), ability to

assess the ulcer before

(p<.001) and after (p<.00)

absorption, barrier

properties (p=.039),

patient comfort during

removal (p<.001), overall

patient comfort (p<.001),

conformability before

(p=.026) and after (p=.001)

absorption, ease of

removal (p<.001), residue

TAAD has favored

performance over the

HD as standard

treatment for stage II

and shallow stage III

pressure ulcer.


100


Length of Follow-up

Results Limitations

in the wound (p=.002),

residue on peri-wound

skin (p<.001), and odor

after absorption (p=.016).

Overall satisfaction

favored the TAAD

(p<.001), and a high value

was placed on its

transparent feature (p<

.001). Mean (SD) wear

time for the TAAD was 5.7

(2.55) days compared with

4.7 (2.29) days for the HD

(p=.086). This one day

difference in wear time

was clinically noticeable by

the investigators (p=.086).

Wound closer for the 2

dressing groups was nearly

identical (p=.9627).

Carr RD, Lalagos DE. Clinical

evaluation of a polymeric

membrane dressing in the

treatment of pressure ulcers.

Decubitus. 1990;3(3):38-42.

Clinical evaluation

70-day evaluation of

18 ulcers on 13 elderly

subjects with stage 1, II,

and III pressure ulcers.

The mean length of time

these ulcers had been

present prior

to the trial dressing was

144 days with 50% of the

ulcers [n - 9)

present for 75 days or

longer.

The findings of this study revealed

that greater than 60% of the ulcers

were completely healed while

greater than 94% were improved

during the study

Diehm C, Lawall H. Evaluation

of Tielle hydropolymer

dressings in the management

of chronic exuding wounds in

primary care. Int Wound J.

2005;2(1):26-35.

1793 PrU patients

3 multicenter,

open-label, single

arm observational

phase IV study

Physicians selected

patients for the study.

Inclusion:

4 weeks duration of

wound; therapy adjusted

based on severity of

symptoms and course of

healing.

No exclusion criteria

Data were recorded at baseline and at

4 or 12 weeks.

Estimate of exudates were scored as:

1= none

2= little/small

3=medium/extensive

4=strong/entire area

Dressings changed 3 times a week

Changes in wound radius and % change

in wound area

Signs of infection

Level of exudate

Age mean 74.5 +/- 13.6

Gender female = 62%

At baseline:

Mean wound age = 2 months

Wound radius = 2.6 cm =/- 1/6

Wound depth = 38.6% deep, 9.2%

had wound pouches and deep

wound pouches

Infection = 47.2%

Exudate =- 36.7% little

28.4% medium, 14% strong

Odor + 23.9% none; 39.7% little;

25.4% medium; 9.5% strong

No control group for

comparison


101


Length of Follow-up

Results Limitations

Wound odor

Portion of necrotic tissue

Portion of fibrous adhesion

Wound status = healed, improved,

unchanged aggravated

Cosmetic result = excellent, good,

moderate, unsatisfactory

Compliance with therapy = much

better, better, equal or worse

Necrotic tissue = 19.9 % none;

49.8% small; 25.6% extensive; 4.2

entire

Portion of fibrinous adhesion =

9.7% none, 53.9% small; 31.5%

extensive 2.3% entire

After 4 weeks: wound radius was

67.4% smaller and 77.9%

reduction in wound size

38.9% PrU healed; 55.9%

improved; 3.3% unchanged and

0.2 aggravated

After 12 weeks: 79.1% reduction in

wound radius and 87.5% reduction

in wound size

57.8% healed, 39.3% improved;

2.5 unchanged and 0.2 aggravated

Cosmetic results of healed ulcers

were excellent or good in 96.9%

Withdrawals from study were

4.5% for insufficient efficacy,

intolerance and worsening of the

wound

Adverse effects occurred in 2.9%

and were pain, general intolerance

and itching

Graumlich JF, Blough LS,

McLaughlin RG, Milbrandt JC,

Calderon CL, Agha SA, et al.

Healing pressure ulcers with

collagen or hydrocolloid: a

randomized, controlled trial. J

Am Geriatr Soc.

2003;51(2):147-54.

Evidence Level = II

Randomized,

single-blind,

controlled

65 patients-residents

with stage II or III

pressure ulcers: 35 were

allocated to topical

collagen dressing and 30

were allocated to topical

hydrocolloid e.

Sample assigned to treatment of 1:1

ratio to daily type I collagen or twice-

weekly hydrocolloid.

Primary efficacy endpoint was the

proportion of pressure ulcers

completely healed within 8 weeks

of randomization. Secondary

efficacy endpoint was time of ulcer

healing, area healed per day, and

linear healing of wound edge.

Study intervention duration was 8

weeks.

Complete healing rate

were the same at 8 weeks,

healing rates were

comparable at earlier time

points too. Collagen

healed 17% (6/35) within 2

weeks and 40% (14/35)

within 4 weeks,

hydrocolloid healed 20%

(6/30) within 2 weeks and

30% (9/30) within 4 weeks.

There was no significant

difference (log rank 0.68, P

No differences in

healing time were

detected between

collagen and

hydrocolloid. Collagen

treatment was more

expensive than

hydrocolloid treatment.

Stratification of initial

ulcer depth or stage

should be considered.


102


Length of Follow-up

Results Limitations

=.409) in time to complete

healing between collagen

and hydrocolloid

treatment.

There were no significant

differences between

collagen for any primary

and secondary efficacy

endpoint. Baseline

measures of ulcer stage,

depth, duration, and area

were only covariates

associated with complete

healing within 8 weeks

(p<.10). only ulcer depth

(odd ratio = 0.56, 95% CI =

0.38-.81, p =.002)

remained a significant

predictor of complete

healing within 8 weeks.

Harding K, Cutting K, Price P.

The cost-effectiveness of

wound management

protocols of care. Br J Nurs.

2000;9(19 Suppl): S6, S8, S10

passim.

Cost-effectiveness

study.

Total of 15 pressure sore

studies involving 519

wound, and 12 leg ulcer

studies involving 843

ulcers were used I pooled

analysis.

Protocols of care were derived for

venous leg ulcers and pressure source

from a detailed literature search of

published clinical research,

supplemented where necessary by the

input of a panel of care experts. This

was followed by the development of

cost-effectiveness models comparing

the different protocols of care. Three

dressing interventions were compared:

the modern hydrocolloids, Traditional

gauze, a skin replacement approach.

Each pressure sore protocol

incorporates 3 aspects of care:

1. assessment

2. wound care

3. care of infection.

Hydrocolloid was the most

cost effective treatment. It

was approximately 50%

more cost-effective than

gauze. Comparing cost

effectiveness of two

modern hydrocolloids,

Granuflex was 50% more

cost effective than

Comfeel.

No information about

clinical effectiveness at

all. *

Kaya AZ, Turani N, Akyüz M.

The effectiveness of a

hydrogel dressing compared

with standard management

of pressure ulcers. J Wound

Care. 2005;14(1):42-4.

Prospective

random

assignment to

Treatment groups

27 subjects, all spinal

cord injured

With 49 PrU

24 males

21 had complete SCI 4

were incomplete injury

Sacral ulcers

6 in control

7 in treatment

Ischial ulcers

3 in control

Hydrogel gel sheet

Povidone –iodine soaked gauze

Location of ulcer

Rate of healing (cm2 of surface

area/days to heal), healing time to

epithelialization

and treatment time

Healing time was computed at

discharge in nonhealed wounds by

subtracted by current size of the

ulcer from the baseline

Results reported on all

ulcers, not subjects

Baseline age, Hgb,

Albumin, TLC, ulcer size

and grade were not


different between groups

Mean healing rate was

higher in treatment (0.02

to 0.36) than in control

(0.03 to 0.23), but not

statistically sig

The stats in this study

are incorrect. We have

reported what we feel is

accurate.

It is odd that the iodine

did not retard wound

healing


103


Length of Follow-up

Results Limitations

6 in treatment

Heel ulcers

2 in control

6 in treatment

Trochanter

4 in control

3 in treatment

Iliac crest

4 in control

0 in treatment

Knee

2 in control

1 in treatment

Head of fibula

2 in control

0 in treatment

Lateral malleolus

2 in treatment

0 in control

Dorsal foot

0 in treatment

1 in control

Kloth LC, Berman JE, Dumit-

Minkel S, Sutton CH, Papanek

PE, Wurzel J. Effects of a

normothermic dressing on

pressure ulcer healing. Adv

Skin Wound Care.

2000;13(2):69-74.

Before after trial

Radiant heat

applied through

semi occlusive

dressing v

standard care

Spinal cord injury and

geriatric unit at VA

20 inpatients with 21

stage II and IV PrU

6 wound control only

15 wounds treatment

group

Semi occlusive heated dressing applied

to 15 stage III and IV PrU or 4.5 hours

M-F for 4 consecutive weeks At other

times receives standard care

4 weeks

Surface area

Wounds treated with heat

healed significantly faster

Small sample size

Kloth LC, Berman JE, Nett M,

Papanek PE, Dumit-Minkel S.

A randomized controlled

clinical trial to evaluate the

effects of noncontact

normothermic wound

therapy on chronic full-

thickness pressure ulcers. Adv

Skin Wound Care.

2002;15(6):270-6.

Prospective,

randomized

VA and 7 LYC

40 inpatients with 43

Stage II and IV PrU

Of 43 wounds 6 control ad 7 treated

with NNWT 21 total wounds

treatment with NNWT and 22 standard

care

Between 3 – 11 weeks of

treatment

Wound healing

No differences initial

wound surface area

Length of time wounds

treated considered the

NNWT was significantly

better

Small sample size

Matzen S, Peschardt A, Randomized Hydrogel 17 Dressing changed daily Time of healing Saline need more weekly Small sample size


104


Length of Follow-up

Results Limitations

Alsbjorn B. A new amorphous

hydrocolloid for the

treatment of pressure sores:

a randomised controlled


Surg Hand Surg.

1999;33(1):13-5.

Evidence Level = II

control study

hydrogel v wet

saline gauze

Wet saline 15

Wounds sacrum or

trochanter areas

Stage II-IV non-infected

Measurements 1X/week Followed 12 weeks or until healed débridement than

hydrogel

Rate of healing was

significantly better

hydrogel

Meaume S, Van De

Looverbosch D, Heyman H,

Romanelli M, Ciangherotti A,

Charpin S. A study to

compare a new self-adherent

soft silicone dressing with a

self-adherent polymer

dressing in stage II pressure

ulcers. Ostomy Wound

Manage. 2003;49(9):44-51.

Evidence Level = II

8 week, open

randomized.

multicenter

controlled study

38 residents

18 randomized to soft

silicone dressing, 20 in

the hydropolymer

dressing

8 (44%) of ulcers in soft silicone

dressing group and 10 (50%) in the

hydropolymer dressing group

healed.

No differences in the signs of

inflammation, amount of exudate,

odor of exudate or leakage were

observed.

Damage to peri-wound skin were

less common in the soft silicone

dressing during the weeks

Meaume S, Vallet D, Morere

M, Téot L. Evaluation of a

silver-releasing hydroalginate

dressing in chronic wounds

with signs of local infection. J

Wound Care. 2005;14(9):411-

9.

Randomized open

label mute-

centered parallel

group

Aqua Cell

13 centers with VLU (n=

71) and stage III/IV PrU

(n=28), wounds were not

infected (no local sign of

infection and not on ABs)

Inclusion Criteria:

continuous pain,

erythema, edema, heat

and moderate to high

levels of serous exudate

Baseline PrU

Duration of treatment

group 4.4 =/- 3.7 months

(median 2.0)

Control group 3.7 =/- 6.0

months

(median 2.0)

Area 22.5 +/- 2.1 cm in

(median 15.6)

Control 22.4 +/- 25.5 cm

(median 18.7)

Severity score

Treatment 17.6 +/- 3.0

Random assignment to silver-releasing

hydroalginate or Ca alginate dressing

Assessed wounds daily x 14 days and

then weekly x 2 weeks

Assessment = modified ASEPSIS index

Débrided of necrotic tissue with

surgical or mechanical methods at

admission and then prn

Global wound severity score and

area tracings were recorded

weekly

Severity score was the % of wound

affected by exudate, odor, necrotic

tissue, color, epithelium

ASEPSIS index is points given for %

of serous exudate, erythema,

purulent exudate and separation

of deep tissue

Other parameters measured

during the study were antibiotics

during the study, I&D,

debridement under general

anesthesia, cultures and prolonged

hospitalization

Nothing provided on R/V on these

measures

PrU decreased in size

Treatment group by -7.2

+/-9.0 cm

Control -0.8 +/- 10.0 cm

p = .117

Healing rate in 4 weeks

Treatment = .26 +/- 0.32

Control = .03 +/- .36

p = .024

% wound reduction at

week 4

Treatment = -31.6 +/- 38.1

Control = -13.9 +/- 50.3

p = .923

Wound severity scores at

week 4 (mean)

Treatment = 12.1 +/- 3.9

Control = 13.8 +/- 4.3

p = 0.171

Groups were the same

at the beginning

No information on who

completed the

assessments (e.g.,

wound nurse)

Stat sig lost due to wide

variation in SD

Wound severity score,

which was most subject

to infections was the

only statistically

significant finding


105


Length of Follow-up

Results Limitations

(median 17.0)

Control 17.4 +/- 3.7

Absolute wound severity

score at week 4

Treatment -5.5 =/- 4.2

Control -3.6 +/- 5.0

P = .063

% decrease in wound

severity score

Treatment -30.7 +/- 23.0

Control -17.5 +/- 32.0

P .034

Dressings best for wounds

at high risk of infection

Moore OA, Smith LA,

Campbell F, Seers K, McQuay

HJ, Moore RA. Systematic

review of the use of honey as

a wound dressing. BMC

Complement Altern Med.

2001;1:2-.

Systematic

reviews of 7 RCTs

in burns and

infected surgical

wounds

Honey compared to

amniotic membrane,

potato peels (N =20) and

polyurethane film

Time to healing

Infection rate

Infected postoperative

wounds comparing honey

to antiseptics and

syste4mic antibiotics

showed much shorter

times for healing,

eradication of infection

and shorter hospital stay

for honey. Portion of

wounds healed without

dehiscence or resuturing

was 22/26 (85%)

compared to 12/24 with

antiseptic.

Moderate to severe burns

showed honey to be less

effective than tangential

excision and grafting. Half

of the patients treated

with honey eventually

needed eventual skin

grafting.

Patients with partial or

superficial burns treated

with honey were

significantly shorter times

to healing than film

dressings, amniotic

Time to healing was

shorter for honey than

all the other treatments


106


Length of Follow-up

Results Limitations

membrane, potato peels

or Silvadene.

Nisi G, Brandi C, Grimaldi L,

Calabrò M, D'Aniello C. Use of

a protease-modulating matrix

in the treatment of pressure

sores. Chir Ital. 2005;57(4

(Print)):465-8.

Evidence Level = II

RCT 40 subjects in each group

PrU cultured, débrided,

disinfected with Betadine

which took from1-6

weeks

Once the wound was completely clean,

group A was treated with 2 or 3 times

weekly collagen with a cover dressing

of hydropolymer patch. Group B was

treated with daily wash with 50%

Betadine, and packed with viscose

rayon gauze and hydropolymer cover

dressing.

Method of measuring wound healing

not provided.

Low Norton scores were

correlated with increased

severity of ulcers.

Ulcers healed in 90% (N=

36) of group A in 2-6

weeks. Time to healing

group B was 2-8 weeks.

Wound healing rates:

36/40 [90%] with protease

modulating matrix v 28/40

[70%] with standard

dressing; P = 0.59).

Group A was hospitalized

360 days compared to

1164 days of

hospitalization in group B

Comparison of groups at

baseline not provided

Pieper B, Sugrue M, Weiland

M, Sprague K, Heiman C. Risk

factors, prevention methods,

and wound care for patients

with pressure ulcers. Clin

Nurse Spec. 1998;12(1):7-12.

Prospective,

Descriptive

N= 694, 71 had PrU Data collection from medical records

on types of dressings

The top three dressings used for

the treatment PrU were

hydrocolloid (n = 52), WTD (n= 38)

and transparent films (n = 16)

Takahashi J, Yokota O,

Fujisawa Y, Sasaki K, Ishizu H,

Aoki T, et al. An evaluation of

polyvinylidene film dressing

for treatment of pressure

ulcers in older people. J

Wound Care.

2006;15(10):449.

Prospective, open

label,

nonrandomized

control trial of

food wrap (a semi

occlusive dressing)

53 patients from 2

geriatric wards in Japan

of Stage III or IV PrU,

using only the most

severe ulcer for inclusion.

Only yellow PrU studied

because they are highly

exudating

26 control

27 experimental

1 treated in the

experimental group got

well and dropped out; 18

subjects dropped out (7

in the experimental and 9

Control was NS cleanser and on yellow

phase ulcers dry gauze and iodine-

sugar (U-Pasta), iodine-cadexomer

paste (Cadex), Silvadene or enzymes

was used on the wound. When the

wound was red, the topical changed to

alprostadil alfadex (Prostandin),

tocoretinate (Olsenon) or bucladesine

(Actosin).

Wounds that needed debridement

were débrided .

Treatment was to cleanse with NS and

cover with non-sterilized PVI film

dressing and closed with tape; the

dead space was not packed. Excess

exudate was drained. (This procedure

was used on ulcers of any stage or level

of inflammation. Dressings were

DESIGN, a tool designed in Japan

was used to measure depth,

exudate, size, infection,

granulation, necrosis + pocket

undermining. Total score ranges

from 0-29, tool has high r/v and

was compared with PSST

DESIGN was used at baseline and

every 4 weeks.

Incidence of adverse events was

also monitored including local

wound infection that developed

into cellulitis, maceration, and

development of eschar .

At baseline, the groups

were the same for gender,

age, mental disorders,

Braden score, stage of PrU,

surface area, location,

state of ulcer (with

cellulitis or undermining)

or systemic disease.

Final sample was 25 in

experimental and 24 in

control group

Systemic infection

independent of the wound

occurred in 8 of

experimental (32%) and 6

(25%) of control group.

Patients were in poor

condition at the start of

the study. The film was

superior to standard

treatment in stage III

and IV ulcers in

inflammatory phase.

From Reviewers:

When the adverse

events were reported in

this study, the

denominator was the

enrolled number, not

the number who

completed the study.

The experimental


107


Length of Follow-up

Results Limitations

in the control group ) due

to death

And 2 in the

experimental group were

transferred.

changed at least daily. If local or

systemic infection developed, the

wound was débrided.

All patients risk was controlled and

included mattresses and chair

cushions.

These patients Braden

were less than 10 and they

died before 12 weeks

By weeks 8 and 12, the

experimental group had


improvement in DESIGN

tool score (median in

experimental 11 and

control was 7)

Surface area mean

16.4 +/- 27.6 cm2

experimental

22.6 +/- 27.9 cm2 control

Maceration of the heel

occurred in patients in the

test group, although not


Complete healing was

seen in 5 (20%) of

experimental and 2 (8%) of

control.

Adverse effects (infection,

maceration and eschar)

was statistically significant

lower in test group (p <

0.03) total

Infection was 4/25 in

experimental group

and 4/24 control (p = NS)

Maceration was 3/25 and

0/25 (p.= 235)

Eschar 0/25 in

experimental group and

6/24 in control group (p=

0.010)

Surgery 5/25 experimental

and 12/24 in control p

=0.039

dressing relied on

autolytic debridement

which

immunocompromised

patients may not have

Thomas DR, Goode PS, RCT 41 residents of a SNF and Randomized to daily application of Weekly measurement of wound Males 53% Results in wound


108


Length of Follow-up

Results Limitations

LaMaster K, Tennyson T.

Acemannan hydrogel dressing

versus saline dressing for

pressure ulcers. A

randomized, controlled trial.

Adv Wound Care.

1998;11(6):273-6.

HHC enrolled , 11

dropped

Inclusion Criteria: stage

II-IV ulcers (1 per subject)

Ulcer area > 1.0 cm2

Exclusion:

Non-pressure ulcers

sinus tracts or

undermining > 1 cm

Clinical infected wounds

Use of other ulcer meds

or steroids

Severe generalized

medical conditions

Survival likely less than 6

months

HIV positive

Drug or ETOH addict

Pregnant/ nursing/or

likely to get pregnant

Cancer or on

chemotherapy

11 subjects dropped; 4

experimental and 2

control died, 1 subject in

each group showed

worsening of the study

ulcer and was

terminated, 1 subject in

each group was

hospitalized and

dropped, 1 subject in

control group was

dropped for protocol

violation

Therefore 30 subjects

were analyzed

AceMannan hydrogel or NS gauze for

daily dressing changes

surface area with tracing and

photograph

Data collected for 10 weeks unless

healing occurred before

Mean age 76 +/- 12 (range

35-97 years)

Caucasian 53%

Black 47%

Stage II 47% (n=15)

Stage III 43% (n= 20)

Stage IV 10% (n = 6)

Mean area of ulcers was

7.6 +/- 7.8 cm2

16 (53%) were

experimental group

14 (47%) were control

group

Rate of healing for both

groups and for stage II and

III

None of the stage IV ulcers

healed

Complete healing was in

19/30 ulcers (63%) in the

10 week period

The odds of healing were

greater in Caucasians,

stage II ulcers and those

with smaller surface areas.

healing were the same

How did they keep

moist gauze moist?

Viamontes L, Temple D,

Wytall D, Walker A. An

evaluation of an adhesive

hydrocellular foam dressing

and a self-adherent soft

Retrospective

chart review of

1891 patients with

4200 wounds.

3969 wounds

Charts of nursing home

patients in Florida, MDS

data used

Mean age was 82.5 (range 29-106);

55% of patients had more than one

wound and 2% had 11 or more wounds

Skin stripping occurred during

dressing removal in less than 1% of

each group

Infection was more frequent in the

Unit of analysis was the

wound


109


Length of Follow-up

Results Limitations

silicone foam dressing in a

nursing home setting. Ostomy

Wound Manage.

2003;49(8):48.

were pressure

ulcers (95%), 18

(>1%) stage I;

1856 (47%) stage

II; 1539 (39%)

stage III; 194 (5%)

stage IV.

Purpose was to

compare

performance of

foam and silicone

dressings

silicone dressed wounds (23%)

compared to 9% of the foam

Yastrub DJ. Relationship

between type of treatment

and degree of wound healing

among institutionalized

geriatric patients with stage II

pressure ulcers. J Case

Manag. 2004;5(4):213-8.

Evidence Level = IV

Random

assignment

polymen

(polymeric

membrane

dressing vs.

antibiotic

ointment and dry

dressing

44 long term care

residents in NY, CVA

patients with Stage II

PrUs

Random assignment to groups All had

same other care Weekly PrU rounds

used PUSH tool

4 weeks

Outcomes rate of healing

PolyMem dressing showed

improved wound healing

Small sample size

Yapucu Güneş U, Eşer I.

Effectiveness of a honey

dressing for healing pressure

ulcers. J Wound Ostomy

Continence Nurs.

2007;34(2):184-90.

RCT over 5 weeks 26 patients with 68 stage

II or III PrU with more

than 2 months Initial

sample dropped 3 DM, 4

terminal patients and 1

refusal

Randomly assigned to group by age,

sex, and ulcer surface area

15 patients with 25 ulcers treated with

honey. Honey used was unprocessed

(raw, natural, organic and

unpasteurized) with a minimum

inhibitory concentration of 3.8%.

Honey was sterilized with radiation.

Ulcer cleansed with NS. Honey applied

to a gauze dressing, 20 ml for a 10 x 10

cm wound. Same cover dressing as

control. Dressing change frequency not

clear (1 or 2 days)

11 patients with 25 ulcers were

cleansed with ethoxy-diaminoacridine

(EDC) followed by nitroflurazone

(Furacin) cream with dressings soaked

with EDC and covered with

semipermeable thin films, Dressing

changed daily or prn soilage

Each group had the same pressure

redistribution and a turning and

PUSH measurements

Acetate tracings for area

Mobility levels assessed via Braden

subscale

Treatment continued until the

wound healed or a maximum of 5

weeks

Age Treatment group 65.8

+/-6.3

Age con group 65.6 +/- 5.5

Ulcers in treatment group

12 sacrum

3 shoulder

5 trochanter

5 heel

Ulcers in con group

12 on sacrum

4 shoulder

2 trochanter

7 heel

At baseline, no sig diff in

age, gender, BMI, mobility

level, Hgb and stage

between groups

PUSH scores showed

healing, Treatment group

showed 4 times the

healing rate. Healing rate

at 5 weeks in honey group

was 12.62 +/- 2.15 PUSH

Honey produces H2O2

and has antioxidants in

it. Honey also has anti-

inflammatory product.

Odor is reduced by

providing an alternative

product for bacterial

metabolism that yields

lactic acid rather than

ammonia, amines and

sulfur which are

odorous.


110


Length of Follow-up

Results Limitations

repositioning program score compared to in

control group of 6.55 +/-

2.12. p < .001

Complete healing in 5

ulcers in 5 weeks in

Treatment group, no PrU

in control group healed

completely

Wanner MB, Schwarzl F,

Strub B, Zaech GA, Pierer G.

Vacuum-assisted wound

closure for cheaper and more

comfortable healing of

pressure sores: a prospective


Surg Hand Surg.

2003;37(1):28-33.

VAC compared to

wet-dry

Randomized trial

22 patient grade 3

(Europe) pelvic region

Did debridement then randomized to

either VAC or wet-dry gauze with

ringers

10 days and 7 days No difference Small, many excluded

Couldn’t use VAC with

incontinence patient


Length of Follow-up

Results Limitations

Baxter H. A comparison of

two hydrocolloid sheet

dressings. Br J Community

Nurs. 2000;5(11):572.

Clinical essay. Ten patients: five

patients were tried with

Duoderm extra thin and

five patients were tried

with Tegasorb thin.

Tegasorb thin and Duoderm extra thin

were essayed and compared in the in-

patient and outpatient clinics. Both

dressings were tried on patients with

leg ulcers, sacral sores, and trauma

wound. Both dressings were also

applied to the tissue joints of a tissue

viability nurse and observed for

performance and durability over a

working day.

Staff and patients were asked their

opinion of two dressings. The two

dressings were compared for the

ease of application and removal,

conformability, wear time, cost,

fluid handling capacity, and patient

comfort.

The comparison was not

conducted on a scientific basis and

confers only anecdotal

observations of the author.

Application was easy on all

wounds, some preference

expressed by clinicians to

the film border and shape

of the oval Tegasorb

dressing for sacral

wounds.

Tegasorb thin was more

easily removed.

Duoderm extra thin was

found to melt in areas

leaving patches of

adhesive and dressing on

the patient’s skin. It is also

found to be pulled apart,

coming off in several

pieces.

Dressing under

compression bandaging

for superficial leg ulcers

were left in place for 7

The two dressings are of

low fluid handling

capacity.

Both dressings

performed well and

were found to be

effective dressing for

superficial, low exudate

wounds.

Tegasorb thin was

found to be easier to

remove, but required

more practice to apply

to areas such as elbow

and heals.

Duoderm extra thin is

slightly less expensive

per unit, but had a

greater tendency for the

edges to roll up.

Patients found the


111


Length of Follow-up

Results Limitations

days. Dressing change

times ranged from 1-5

days for other wounds.

Duoderm extra thin was

easy to apply and

conformed extremely well

to an elbow joint, while

the oval Tegasorb thin was

more difficult to apply.

Duoderm’s edges had

occurred and the dressing

had started to stick to

clothing, while the

Tegasorb was easier to

remove with less trauma

and pulling of the skin with

some discomfort.

No differences were

observed in the fluid

handling or healing

properties of the two

dressings, some

maceration of the

surrounding skin was

observed with both

dressings when used in leg

ulcers under compression

for 7 days.

No adhesive reactions

were observed with either

wound dressing. Both

dressings were

comfortable and

acceptable for most

patients with some

discomfort felt with the

removal of the dressings.

The Tegasorb thin range is

slightly more expensive

per unit than the Duoderm

extra thin range. The cost

is only a few pence per

dressing.

dressings comfortable

and acceptable with

pain reduction reported

in superficial pressure

sours and trauma

wounds.

Bergemann R, Lauterbach

KW, Vanscheidt W, Neander

Cost analysis

prospective

5 patients with 4 PrU, 1

leg wound

Cost data included material cost for

wound dressings and time

Gauze dressings with

Ringer’s solution were 20-

Gauze is expensive

when time is factored


112


Length of Follow-up

Results Limitations

KD, Engst R. Economic

evaluation of the treatment

of chronic wounds:

hydroactive wound dressings

in combination with

enzymatic ointment versus

gauze dressings in patients

with pressure ulcer and

venous leg ulcer in Germany.

Pharmacoeconomics.

1999;16(4):367-77.

40 cents per dressing and

time required to changed

was 22 minutes using 2

nurses (cost was $44.88

for 2)

Impregnated gauze (50

cents to $1.00 with 2

nurses for 20 minutes

each.

Ca alginate dressings also

took 2 nurses for 20

minutes

Cutiniova hydroactive

dressing took one nurse 26

minutes and cost $26.52

into cost.

Burrell RE, Heggers JP, Davis

GJ, Wright JB. Efficacy of

silver-coated dressings as

bacterial barriers in a rodent

burn sepsis model. Wounds.

1999;11(4):64-71.

Experimental 120 Sprague-Dawley rats A virulent strain of Pseudomonas was

serially diluted into 5 solutions and

inoculated onto burn wounds on

Sprague-Dawley rats.

Groups included a control group of

gauze with mesh, and a group with the

same dressing saturated with silver

nitrate or nanocrystalline silver coated.

A group that had no dressing and one

group were infected but no dressing.

Time of study was 15 days

Death, mean days to death were

outcomes

Burn control (no dressings

and no infection)

20/20 all survived.

Infected group (all

inoculated, no dressing)

1/20 survived, mean

days to death 6.2

Dry dressing group

0/20 survived, mean days

to death = 4.8

Silver nitrate group

0/20 survived, mean days

to death = 5.9

Nanocrystalline drugs

34/40 survived

Mean days to death 10.2

While this is a burn

animal model, it shows

the efficacy of Ag on

Pseudomonas when

delivered by dressings

Dowsett C. The use of silver-

based dressings in wound

care. Nurs Stand.

2004;19(7):56-60.

1 patient with a grade IV

PrU, draining pus and

odorous

Aqua Cel with Ag placed in wound

cavity

Complete wound healing at 9

months

Dressings reduced from

daily to 3 times per week

Acticoat is a low

adherent primary

wound dressing,

nanocrystals release at

70 mg/l. Has the most

rapid effect

AquaCel Ag is a

hydrofiber with ionic

silver, dressing is

absorbent

Contreet is a

polyurethane foam,

silver is released when


113


Length of Follow-up

Results Limitations

dressing contacts

exudate. Slower onset

of action than Acticoat

Actisorb Ag is activated

charcoal with metallic

silver, broad spectrum

including fungi and

bacteria. Odor is

reduced with activated

charcoal.

Urgotul SSD is a

hydrocolloid with silver

sulfadiazine

Avance is a

polyurethane foam with

a silver complex.

Silver stains the wound,

but is removable with

cleansing. No known

bacterial resistance.

Gray M, Jones DP. The effect

of different formulations of

equivalent active ingredients

on the performance of two

topical wound treatment

products. Ostomy Wound

Management. 2004;50(3):34.

Subset of human

patients with

experimentally

created wounds in

a larger study that

included

hydrocolloid and

saline dressings

This was

comparing balsam

of Peru, castor oil

and trypsin

ointment

(Xenaderm) and

balsam of Peru,

castor oil and

trypsin spray

(Granulex)

Subjects were at least 65

years old

Inclusion: over age 65

Exclusion: not taking

medications that could

affect coagulation and no

wounds or scars on thigh.

Partial thickness wound (6 mm

diameter) created on upper outer thigh

with ERbium-YAG Laser

Random assignment to spray,

ointment or saline dressings

Erythema, scabbing, edema and re-

epithelialization measured every other

day

Wounds treated with

ointment had less

erythema, edema,

scabbing and greater

healing

Not a pressure ulcer

study

Kerstein MD. Unexpected

economics of ulcer care

protocols. South Med J.

2004;97(2):135-6.

Literature review. 36 randomized

controlled studies focus

on saline, hydrocolloid,

and human skin

construct.

Randomized controlled studies

conducted between 1984 and 1999

were reviewed by a panel of wound

care experts.

Cost of managing chronic ulcers,

including both venous leg ulcers

and decubiti.

Among the key points

appeared in the literature:

at least 12 weeks are

required to achieve 50%

healing of wound (10X10

Decisions regarding

ulcer treatment

protocols should not be

relayed solely on the

initial cost of materials.


114


Length of Follow-up

Results Limitations

cm) when using

hydrocolloid dressing plus

Hydrocolloid dressing is

the most cost effective

when considering the

labor intensive of

dressing changes 3-4

times per day.

Kohr R. Clinical focus: wound

care. Moist healing versus

wet-to-dry. Can Nurse.

2001;97(1):17-9.

Case study 1 case study Cost comparison of tid WTD for 3

days to hydroactive gel with one

occlusive dressing for 3 days

Case study patient had

decreased analgesic needs

and less home care needs

(q 4 days) with healing

time at 4 weeks post

discharge

WTD cost $2.50 for

dressings and $20 for

nursing = 675 (we

recomputed for 9 days =

$607.50

MWH $8.00 for product

plus $20 for nursing =

$84

Morris L. Clinical efficacy of C-

View transparent film wound

dressing. Br J Nurs.

2001;10(9):616-20.

Case studies 5 of mixed wounds, 2

were PrU on sacrum

C view transparent film applied to

necrotic eschar in one patient, and a

stage I on the sacrum

Examined dressings for wear time,

comfort, wrinkling, peri-wound

maceration, sensitivity reaction,

and performance.

Ability to protect skin from shear

and friction

as a secondary contact layer

Economic factors also examined

Wear time 3 days

Comfort = unknown

Wrinkling = none

Periwound maceration =

none including the one

patient with eschar

treated with hydrogel

Sensitivity = none

Staff liked the distensibility

of dressing, stayed on

longer so was less

expensive, easily to apply

and remove

Motta GJ, Milne CT, Corbett

LQ. Impact of antimicrobial

gauze on bacterial colonies in

wounds that require packing.


2004;50(8):48-62.

Perspective

randomized 5

week controlled,

open label,

multicenter study

Compared gauze

dressing with

antimicrobial to

control gauze

without anti-

microbial in PrU,

surgical wounds

and diabetic foot

wounds

18 year or older, wounds

required packing,

necrotic tissue <20%

No antibiotic therapy

24 total (12 each group)

11 completed treatment

group (4 PrU) and 10

control (3 PrU)

Wound irrigation with S and lightly

packed wounds with group’s assigned

dressing both groups.

Secondary dressing applied both

groups

Wound size and 1 wound

assessment parameters using

WASPT, swab cultures for bacterial

colony counts

5 week

Lower bacterial count I

antimicrobial gauze group

No data on healing rates

Mixed types of wounds,

very small sample

Schulze HJ. Clinical evaluation

of TIELLE* Plus dressing in the

management of exuding

2121 patients with

wounds; 20.7%

PrU

Within the 12 week observation

period, 43% of the wounds healed

and 50.4% were improved

From abstract


115


Length of Follow-up

Results Limitations

chronic wounds. Br J

Community Nurs. 2003;8(11

Suppl):18-22.

Observed for 12

weeks after

changing to Tielle

Sibbald RG, Browne AC,

Coutts P, Queen D. Screening

evaluation of an ionized

nanocrystalline silver dressing

in chronic wound care.


2001;47(10):38-43.

Uncontrolled ,

prospective open-

label study


nonhealing wounds

9 DFU

6 VSU

2 PrU

12 Misc

PrU patients were

admitted if they had less

than 30% healing in 4

weeks, a

therapeutic surface

Hgb > 8.0

Albumin > 1.2

No cardiac or kidney dx

Appears that silver dressing were

applied, no information on frequency

or use of a control group. There is a

note that this is a 4 arm study.

Wound tracing and exudate

(amount, type and odor) were

assessed

Granulation tissue noted to be

firm, friable, or excess

Qualitative cultures at baseline,

weeks 2 and 4

Followed for 6 weeks

PrU (N = 2) had decreased

exudate and size of ulcer

Surface flora reduced, but

qualitative wound cultures

did not show reduction in

organisms and still

required systemic therapy.

Silver is potentially safe

topical wound

treatment but does not

control infection in

deeper tissues

Van der Weyden EA. The use

of honey for the treatment of

two patients with pressure

ulcers. Br J Community Nurs.

2003;8(12):S14-20.

Case studies 2 patient with PrU

Alginate dressing with honey (Apinate

made in New Zealand)

Serial monitoring of wound size

and photos

Odor and pain was noted

Lateral ankle initially 4 x

2.5 healed in 11 weeks,

reduction in odor and pain

Sacral was initially 2 x1

with 6 x 5 erythema,

healed in 8 weeks,

reduction in odor

Honey was used as an

autolytic débrider

Voigt DW, Paul CN. The use of

Acticoat as silver impregnated

telfa dressings in a regional

burn and wound care center:

the clinicians view. Wounds.

2001;13(2):11-22.

Case review of 10

patients (but chart

data only lists 7

patients)

7 patients per chart with

pressure ulcers

ActiCoat used with no discussion of

prior treatment or general treatment

of patient

Wound volume

Duration

Time in days to heal

Volume of healing over time

PrU in 5 patients who died

prior to being healed

Ave starting volume 493

mm3

Ave max volume 957

mm3

Duration prior was 3.8

months

Treated for average of 70

days

Wound volume

decreased by 564 mm3

(due to increase in initial

wound size after treating)

PrU in 5 patients who did

not die prior to being

healed

Ulcers that healed were

significantly smaller

Patients reported less

odor from ulcers


116


Length of Follow-up

Results Limitations

Ave starting volume 196

mm3

Ave max volume 957

mm3

Duration prior was 7.0

months

Ave time to heal

wounds was 35 days

Wound volume decreased

by 564 mm3 (due to

increase in initial wound

size after treating)


117

Table 9. Assessment and Treatment of Infection Direct Evidence


Length of Follow-up

Results Limitations

Gunes UY, Eser I.

Effectiveness of a honey

dressing for healing pressure

ulcers. J Wound Ostomy

Continence Nurs.

2007;34(2):184-90.

Good

Also in Table 9 - dressings

Randomized

clinical trial

26 patients: 15 patients

with 25 PrU treated with

honey vs. 11 patients

with 25 PrU treated with

ethoxy-diaminoacridine

plus nitrofurazone

Compared effect of honey dressing

vs. ethoxy-diaminoacridine plus

nitrofurazone dressing on the

healing of stage II or III PrU using

PUSH scores

Study not blinded,

limited to stage II-III,

variability in potency of

antimicrobial effects

with unprocessed

honey, not clear if

cleanser ethoxy-

diaminoacridine alone

could have affected

results

Heym B, Rimareix F, Lortat-

Jacob A, Nicolas-Chanoine

MH. Bacteriological

investigation of infected

pressure ulcers in spinal cord-

injured patients and impact

on antibiotic therapy. Spinal

Cord. 2004;42(4):230-4.

Fair

Retrospective 168 surgical samples

from spinal cord injured

patients with full

thickness PrU

Tissue specimens at the end of surgical

intervention were taken and used to

target antibiotic treatment

Used semi-quantitative method,

antibiotic susceptibility using agar

disc diffusion method

Culturing PrU

from surgically cleansed

sites allows for isolation of

bacteria species &

antibiotic susceptibility

Aggressive cleansing &

debridement of ulcer

during OR might have

effected results


Kitayama Y, Ishikawa S,

Togashi H, et al. Skin debris

and micro-organisms on the

peri-wound skin of pressure

ulcers and the influence of

peri-wound cleansing on

microbial flora. Ostomy

Wound Manage.

2005;51(1):50-9.

Good

Also in Table 7 - Cleansing

Descriptive study

of 17 long-term

care patients with

stage III/IV ulcers

17 ulcers: 7 sacrum, 7

trochanter, 3 ischial

Collect & analyze skin debris found on

peri-wound skin of patients with PrU &

to evaluate effect of peri-wound

cleansing on micro flora on peri-wound

& wound bed

Skin debris collected: wound bed,

1 cm (peri-wound) and 10 cm

(normal skin) from wound before

cleansing, protein largest quantity

of skin debris (keratinized cells),

counts increased with the amount

of protein

Per wound cleansing

caused a decrease in

wound/peri-wound

microbial counts so

authors suggest peri-

wound cleansing daily

Sample size small, also

location of ulcer (area of

contamination) may

affect microbial load,

elderly pop only, its

effect on healing was

not studied


118


Length of Follow-up

Results Limitations

Bill TJ, Ratliff CR, Donovan

AM, Knox LK, Morgan RF,

Rodeheaver GT. Quantitative

swab culture versus tissue

biopsy: a comparison in

chronic wounds. Ostomy

Wound Manage.

2001;47(1):34-7.

Good

Prospective,

nonrandomized


wounds

Compared quantitative tissue biopsy

with quantitative swab in chronic

wounds

Evaluate the accuracy of

quantitative swabs

79% (28 of 38) of cultures,

both showed >105

18 PrU wounds

Cutting KF, White RJ,

Mahoney P, Harding KG.

Clinical identification of

wound infection: a Delphi

approach in European Wound

Management. Identifying

criteria for wound infection

EWMA Position Document.

London2005. p. 6-9.

Strong- beginning to correlate

clinical features with micro

lab results

2004 Delphi

Survey to id

clinical signs of

wound infection in

6 wound types

54 members of which 8-

10 on each wound panel

Panel asked to list clinical indicators of

infection, then scored list from 1st

round as to importance, rescored with

eliminating lower scores

Clinical indicators of infection and

rank them according to

importance: cellulitis, odor, pain,

delayed healing, wound

breakdown common to all

Pressure ulcers: cellulitis

high mean score, changes

in pain, crepitus, increase

in exudate, pus, serous

exudate with

inflammation, viable tissue

becoming slough, peri-

wound warmth, wound

stops healing all had

medium mean score

Definitions that were

used may not be clear,

relevance may not be

related to infection i.e.

poor nutrition could

cause delayed healing

Davies CE, Hill KE, Newcombe

RG, Stephens P, Wilson MJ,

Harding KG, et al. A

prospective study of the

microbiology of chronic

venous leg ulcers to

reevaluate the clinical

predictive value of tissue

biopsies and swabs. Wound

Repair Regen. 2007;15(1):17-

22.

Strong

Prospective,

nonrandom

70 patients with clinically

non infected venous

ulcers

Whether there is a relationship

between wound microflora and

healing, usefulness of biopsies vs.

swabs

66 patients followed monthly for 6

months, 20 healed but 6 recurred

within 6 months, 4 lost to follow-

up

Microbial load by swab

was predictive of

nonhealing & data from

biopsy does not enhance

the data

Looked at Venous ulcers

and no pressure ulcers

Gardner SE, Frantz RA, Troia

C, Eastman S, MacDonald M,

Buresh K, et al. A tool to

assess clinical signs and

Development and

reliability testing

of clinical signs

and symptoms

31 patients from 4 sites

including acute care,

outpatient, long-term

care

Development and testing CSSC tool to

assess chronic wounds for 12 signs of

clinical localized infection

Standardize assessment-2

independent assessments for 31

patients using CSSC, percent

agreement & Kappa

16 PrU patients(52%), all

items had acceptable

reliability estimates. Heat,

odor, & discoloration of

Nurses need training

and this training may

have contributed to

high level of agreement


119


Length of Follow-up

Results Limitations

symptoms of localized

infection in chronic wounds:

development and reliability.


2001;47(1):40-7.

Strong

checklist for local

chronic wound

infection

gran tissue had moderate

agreement while pain,

edema, wound

breakdown, delayed

healing, & friable gran

almost perfect agreement

Gardner SE, Frantz RA,

Saltzman CL, Dodgson KJ.

Staphylococcus aureus is

associated with high

microbial load in chronic

wounds. Wounds.

2004;16(8):251-7.

Strong

Observational

cross-sectional

Nonarterial full thickness,

chronic wound patients,

66 wounds in the study

Identify the relationship between: S.

aureus and clinical signs of infection,

microbial load, number of different

species in the wound

Did not do serial micro analysis of

wounds over time, 51 of 66

wounds-diabetic

S. aureus isolated from 34

(52%) of wounds but

predominate organism in

only 29%. No statistically

significant difference

between SA & non-SA

whether they appeared

clinically infected, SA

wounds significantly more

likely to contain >105 than

non-SA wounds, mean # of

species from each wound-

2.7, 12(18%)- appeared

clinically infected,

24(36%)->105 positive

biopsies

5 PrU wounds: 3 with SA

& 2 non-SA. Technique

for isolation of

anaerobes- used only 48

hour incubation

Gardner SE, Frantz R, Hillis SL,

Park H, Scherubel M.

Diagnostic validity of semi

quantitative swab cultures.

Wounds. 2007;19(2):31-8.

Strong but only had 2 PrU

wounds which were not

infected

Observational

cross-sectional

44 Adults with chronic

wounds: 15 >106 29 <106

Exam accuracy of semi, quant,

compared to tissue biopsy using

Levine’s tech

Used 10 6 as definition of infection Semi-quant swabs do not

correlate with tissue

specimens

Only had 2 PrU patients

and they were not

infected

Gardner SE, Frantz RA, Park

H, Scherubel M. The inter-

rater reliability of the Clinical

Signs and Symptoms Checklist

in diabetic foot ulcers.


2007;53(1):46-51.

Strong

Observational

cross-sectional

64 diabetic foot ulcer

patients

Exam reliability of revised CSS Checklist

in sample of diabetic foot ulcer

patients

2 nurses used checklist on 64

patients. Reliability of each item

calculated using percent

agreement & Kappa coefficient,

Items: pain, erythema, edema,

heat, purulent exudate,

sanguineous drainage, delayed

healing, discolored, friable

granulation, pockets, odor,

breakdown

Total percent agreement

ranged from 76-100% and

kappa ranged from .34 to

1.0 showing it is a reliable

tool for identifying signs of

localized infection

All diabetic plantar

ulcers. Most dressed

with gauze, nurses were

trained in chronic

wounds


Saltzman CL, Hillis SL, Park H,

Scherubel M. Diagnostic

validity of three swab

Observational,

cross-sectional

Adults with chronic full

thickness wounds (except

no arterial wounds)-83

wounds with 6 PrU

Exam diagnostic validity of 3 swab

techniques ( Z, Levine, biopsy) in

identifying chronic wound infection

Used 106 as definition of infection,

other parameters-number of

different organisms, pathology of

organisms

Swab using Levine’s

performed better than

wound exudate or Z tech

Only used 6 PrU wounds

and all 6 were not

infected.


120


Length of Follow-up

Results Limitations

techniques for identifying

chronic wound infection.

Wound Repair Regen.

2006;14(5):548-57.

Strong study but only 6 PrU

wounds which were not

infected


Doebbeling BN. The validity

of the clinical signs and

symptoms used to identify

localized chronic wound

infection. Wound Repair

Regen. 2001;9(3):178-86.

Strong

Cross-sectional

design

PCW assessed for 12

signs of infection, 36

enrolled

Validity of signs used to identify

chronic wound infection i.e. sensitivity

and specificity of list compared to

tissue biopsy,

Secondary signs expressed more

frequently than classic signs,

however no one sign achieved

100% sensitivity

Patients receiving systemic

antibiotics were less likely

to have infected wounds,

validity of signs was

supported with exception

of pocketing of wound

base

19 PrU with 3 being

infected and 16 being

noninfected, limited

generalizability

Neil JA, Munro CL. A

comparison of two culturing

methods for chronic

wounds... including

commentary by van Rijswijk L,

Stotts NA, and Soeken KL.


1997;43(3):20.

Fair-small sample

Nonexperimental,

descriptive

10 chronic wounds Evaluated 10 chronic wounds for

comparison of Brentano wet culturing

tech with quant biopsy

Wilcoxon matched pair test

indicated groups not equal & tissue

cultures had significantly larger

number of cfu, Pearson’s

correlation showed swab counts

didn’t predict tissue counts

Wet culture correctly

indicated infection 80% of

the time

Debrided wounds prior

to culturing, small

sample, only aerobic

cultures, only 1 PrU

Ratliff CR, Rodeheaver GT.

Correlation of semi-

quantitative swab cultures to

quantitative swab cultures

from chronic wounds.

Wounds. 2002;14(9):329-33.

Good

Prospective,

nonrandomized

124 wounds swabbed Compare quantitative swabs with

semi-quantitative swabs in chronic

wounds

Linear regression demonstrated a

statistically significant correlation

between the 2 tech with

coefficient of r = 0.84 with p <

0.001

53/124 quant swabs >105,

42 semi-quant on same

wounds had growth on

quad III/IV for sensitivity of

79%

44 PrU wounds

Indirect Evidence (Topical Agents for Infection) Reference Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Banwell H. What is the

evidence for tissue

regeneration impairment

Search of 6

databases

41 articles Range of literature available on PVP-I

use & evidence supporting its use &

effect on tissue impairment

9 experimental studies- no

evidence of negative impact of

tissue regeneration with PVP-I, 6

Effect size of 1 (i.e. n=1),

small (n< 50), medium

(n<400), large (n>400).

Many assumptions

made, article

availability. Bias with


121


Length of Follow-up

Results Limitations

when using a formulation of

PVP-I antiseptic on open

wounds? Dermatology.

2006;212 Suppl 1:66-76.

Good

articles refuted this, one

inconclusive, also looked at articles

with descript studies, expert

opinion

Much debate over use

especially 10% in

soln/ointment

using reader scoring

tool

Bergin SM, Wraight P. Silver

based wound dressings and

topical agents for treating

diabetic foot ulcers. Cochrane

Database Syst Rev. 2007(2).

Strong

Randomized trials

& nonrandomized

Diabetics with foot ulcers To evaluate effects of silver

dressings/topical agents on infection

rates & healing of diabetic foot ulcers

Despite widespread use,

no randomized control

trials or controlled trials

exist that evaluate their

effectiveness

Bradley M, Nelson EA,

Pettigrew M, Cullum N,

Sheldon T. Dressings for

pressure sores. Cochrane

Database Syst Rev.

1998;3:CD001179.

Strong

Randomized and

pseudo-

randomized

(alternate

allocation)

Search trials from

Cochrane Wounds

Group, Cochrane

controlled trials

To evaluate the effectiveness of

dressings used in the treatment of

pressure sores

Time to complete healing or rate of

healing

This is a protocol

Cutting KF. Identification of

infection in granulating

wounds by registered nurses.

J Clin Nurs. 1998;7(6):539-46.

Fair

Training is key to

identification of subtle signs

of infection

Questionnaire

including

observational

about infection

status of wound

20 RNs in pairs over 10

weeks viewed 4 wounds

for total of 40 wounds

Insight into criteria used to identify

infection compared RNS with author

RNs not always able to accurately

identify infection in granulating

wounds, author’s accuracy-39 out

of 40 decisions (97.5%)

Varying levels of RN

wound education

No burns/leg ulcers

looked at wounds

healing by 2ndary

intention, RNS of

varying experience,

unknown if PrU

included

Howell-Jones RS, Price PE,

Howard AJ, Thomas DW.

Antibiotic prescribing for

chronic skin wounds in

primary care. Wound Repair

Regen. 2006;14(4):387-93.

Good- need to look at

antibiotic prescribing

practices –role, duration, role

in resistance

Retrospective data

base from general

practice databases


wounds were identified

(PCW)

Quantity and pattern of antibiotic

prescribing for patients with chronic

wounds in the UK

N/A over 2/3 of PCWs received

at least 1 course of

systemic antibiotics

compared with 1/3 of non-

wound patients, diabetes

had no significant impact,

leg ulcers & venous ulcer

most common

68 patients with PrU,

retrospective chart

review

Nelson EA, O'Meara S, Golder RCTs and CCTs Searched 16 databases Review the evidence for antimicrobial Evidence is too weak 23 studies Trials too small and


122


Length of Follow-up

Results Limitations

S, Dalton J, Craig D, Iglesias C.

Systematic review of

antimicrobial treatments for

diabetic foot ulcers. Diabet

Med. 2006;23(4):348-59.

Strong

intervention for diabetic foot ulcers dissimilar

Jull AB, Rodgers A, Walker N.

Honey as a topical treatment

for wounds. Cochrane

Database Syst Rev.

2004;2:CD005083.

Strong

Randomized and

pseudo-

randomized

(alternate

allocation)

Search trials from

Cochrane Wounds

Group, Cochrane

controlled trials, AMED,

LILACS, experts

To assess whether use of honey has

any benefit in wound healing:

increases the rate of healing in acute &

chronic wounds

Time to complete healing,

proportion of wounds healed

This is a protocol

O'Meara S, Cullum N, Majid

M, Sheldon T. Systematic

reviews of wound care

management: (3)

antimicrobial agents for

chronic wounds; (4) diabetic

foot ulceration. Health

Technol Assess. 2000;4(21):1-

237.

Strong

30 studies, 25

with random, 9

evaluations of

systemic agents

and 21 topical

agents

18 databases Relevant

journals, confer, & bibs

were hand searched

Any systemic or topical agents with

antimicrobial prop including

antibiotics, anti-fungal preps, anti-viral

and alternative approaches

Primary outcome was wound

healing such as change in ulcer

size, rate of healing, frequency of

complete healing or time to heal.

Studies reporting solely micro

outcomes were excluded

PRU- no systemic trials,

several topical agents may

be helpful in general for

chronic wounds but

further research for

effectiveness so cost

minimization may be used

to guide decisions

Methodological

problems with most

common being sample

size

O’Meara S, Cullum N, Majid

M, Sheldon T. Executive

Summary: Systematic reviews

of wound care management:

(3) antimicrobial agents for

chronic wounds; (4) diabetic

foot ulceration. Health

Technol Assess. 2000;4(21).

Strong

Random &

nonrandom trials

with concurrent

control group

which evaluate

intervention for

prevention or

treatment of

diabetic ulcers or

topical

antimicrobial for

chronic wounds

(including PrU)

19 databases including

Medline, CINAHL,

Embase & Cochrane.

Relevant journals, confer,

& bibs were hand

searched

Diabetic-39 trials

Antimicrobials- 30 with 25 of

randomized design. 9 evaluations of

systemic antibiotics, 21 of topical

agents

Antimicrobials-PrU: no evidence in

favor of topical antimicrobials for

PrU prevention, oxyquinolone

ointment significantly more

effective than standard emollient

for treatment of PrU in 1 study, no

significant difference between

hydrocolloid and povidone iodine

ointment or between gentian

violet and povidone iodine/sugar

ointment

most have insufficient

statistical power to detect

true treatment effect

Methodological quality

poor

O'Meara S, Nelson EA, Golder

S, Dalton JE, Craig D, Iglesias

C. Systematic review of

methods to diagnose

infection in foot ulcers in

diabetes. Diabet Med.

RCTs and CCTs 19 databases plus other

sources

Systematic review of diagnostic

performance of clinical exam, sample

analysis in infected diabetic foot ulcers

Inconclusive because of sample

size

3 studies Too small and too few


123


Length of Follow-up

Results Limitations

2006;23(4):341-7.

Strong

Parsons D, Bowler PG, Myles

V, Jones S. Silver

antimicrobial dressings in

wound management: a

comparison of antibacterial,

physical, and chemical

characteristics. Wounds.

2005;17(8):222-32.

Good

In-vitro

experimental

7 dressings:

Aquacel Ag,

Acticoat, Silvercel,

Contreet foam, polymem

silver, urogotul, silvasorb

Compared in-vitro antibacterial activity

of 7 silver dressings against S. aureus

and P. aeruginosa-silver release and/or

silver content

Repeat challenge assays over 7

days for each dressing and a

control dressing

Silver content not found to

be predictor of

antibacterial activity so

choice of dressing should

not be based on this alone

Technique used

measured total

amount of silver in

solution and cannot

differ. between active

and inactive forms

Ubbink DT, Vermeulen H,

Storm-Versloot MN. Topical

silver for preventing infected

wounds. (Protocol). Cochrane

Database Syst Rev. 2007;ID:

CD006478(2) DOI:

10.1002/14651858.CD006478

).

Strong

Randomized and

pseudo-

randomized

(alternate

allocation),

published and

unpublished

Search trials from

Cochrane Wounds

Group, Cochrane

controlled trials

To evaluate the effectiveness of

dressings and topical agents containing

silver to prevent wound infection of

wounds of any etiology in any care

setting

Studies must report objective

measure of established wound

infection rate, objective measure

of wound healing rate, days of

wound infection

This is a protocol

Vermeulen H, van Hattem JM,

Storm-Versloot MN, Ubbink

DT. Topical silver for treating

infected wounds. Cochrane

Database Syst Rev.

2007(1):CD005486.

Strong

Systematic review 3 RCTS for 847

participants

1 trial compared silver-containing

foam(Contreet®) with hydrocellular

foam (Allevyn®) in leg ulcer patients. 2

trial compared silver-containing

alginate(Silvercel®) with alginate

(Algosteril®) in leg and pressure ulcers

3 trial compared a foam dressing

(Contreet®) with best care for chronic

wounds

4 weeks of follow-up Insufficient evidence to

recommend use of silver-

containing dressings or

topical agents for

treatment of infected or

contaminated chronic

wounds,

Greater reduction in ulcer

size was observed with

silver-containing foam but

no significant difference in

rates of complete healing

after 4 weeks

Only 3 trials with short

duration of follow-up,

small numbers and of

low power, duration of

wound infection not

mentioned


124

Table 10. Biophysical Agents Electromagnetic Spectrum Reference Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Adegoke BO, Badmos KA.

Acceleration of pressure ulcer

healing in spinal cord injured

patients using interrupted

direct current. Afr J Med Med

Sci. 2001;30(3):195-7.

Indirect evidence, less than

10 subjects

RCT 6 SCI with Pressure

Ulcers

Interrupted DC Pressure ulcer size IDC group: 22% decrease

in size; nursing group :

2.6% decrease in size

Small sample. One

patient dropped out

of study. Supports

work of prior studies

that ES is effective in

reducing pressure

ulcer size

Baker LL, Rubayi S, Villar F,

DeMuth SK. Effect of

electrical stimulation

waveform on healing of

ulcers in human beings with

spinal cord injury. Wound

Repair Regen. 1996;4(1):21-8.

RCT N= 185 controls N ?

SCI with PrU

Asymetric Biphasic Wound healing Wound healing rates

increased by 60% over

controls

Edsberg LE, Brogan MS,

Jaynes CD, Fries K. Topical

hyperbaric oxygen and

electrical stimulation:

exploring potential synergy.


2002;48(11):42.

Also see hyperbaric oxygen

Pressure ulcers

Prospective,

uncontrolled

N = 8 Enhanced wound closure with

topical HBO and topical HBO &


No significant difference

between topical HBO

alone and topical HBO

with electrical stimulation

Larger, controlled

study to determine

efficacy needed

Recommendation

based on data from all

chronic wound types

Flemming K, Cullum N.

Electromagnetic therapy for

the treatment of pressure

sores. Cochrane Database

System Rev(Online).

2001(1):CD002930

Systematic Review

Systematic Review

N = 10 Stage II; N=10

stage III

Induced ES ( PRFS)

Pressure ulcer healing Stage II: Median no of

days to healing 13.0;active

group 84% healed at 1

week; sham 40% healed in

1 week ; Median no of

days to healing 31.5; Stage

III active decreased area

5.9% /week; sham 1.7%

/week

Results of both trials

suggestive of a benefit

associated with

electromagnetic

therapy


Schmidt FL. Effect of electrical

stimulation on chronic wound

Meta-analysis 15 studies

Meta-analysis

Mixed types of electrical stimulation Pressure ulcer healing Electrical stimulation was

most effective on pressure

ulcers (net effect = 13%).


125


Length of Follow-up

Results Limitations

healing: a meta-analysis.

Wound Repair Regen.

1999;7(6):495-503.

Electrical stimulation

produces a substantial

improvement in the

healing of chronic wounds,

further research is needed

to identify which electrical

stimulation devices are

most effective and which

wounds respond best to

this treatment

Stefanovska A, Vodovnik L,

Benko H, Turk R. Treatment

of chronic wounds by means

of electric and

electromagnetic fields. Part 2.

Value of FES parameters for

pressure sore treatment.

Med Biol Eng Comput.

1993;31(3):213-20.

RCT N=185

Pressure ulcers , SCI

Biphasic electrical stimulation Pressure ulcer healing Healing rate improved by

60% compared to controls

Phototherapy (Laser, Infrared (with and without warming, Ultraviolet) Reference Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Dehlin O, Elmståhl S, Gottrup

F. Monochromatic

phototherapy: effective

treatment for grade II chronic

pressure ulcers in elderly

patients. Aging Clin Exp Res.

2007;19(6):478-83.

Pressure ulcers

RCT

N = 164 Monochromatic photo therapy Time to healing calculated using

survival analysis

No significant effects

overall; sub-analysis

tendency toward

enhanced healing;

significantly larger

reduction in pressure

ulcers among patients with

low BMI

May be beneficial to

healing in individuals

with low BMI

Nussbaum EL, Biemann I,

Mustard B. Comparison of

ultrasound/ultraviolet-C and

laser for treatment of

pressure ulcers in patients

with spinal cord injury. Phys

Ther. 1994;74(9):812-23.

Also see acoustic energy

Small RCT

a control group

(n = 9), a US/UVC group

(n = 5), and a laser group

(n=6).

20 patients

Spinal cord unit/hospital

Combined therapy of ultrasound

and UVC with standardized wound

care for individuals with pressure

ulcers resulted in faster healing

times than standardized wound

care combined with laser.

Results showed that

USIWC treatment had a

greater effect on wound

healing than did nursing

care, either alone or

combined with laser.

Ultrasound-ultraviolet-C

may decrease healing time

Difficult to draw

conclusion as 2

treatment types

combined and

compared against

laser

However, U/S has

been shown to


126


Length of Follow-up

Results Limitations

and may allow faster

return to rehabilitation

program, work, and leisure

activities for patients with

spinal cord injury who

have pressure ulcers.

enhance healing in a

number of studies (10)

in chronic wounds and

UVC has been shown

to enhance healing

and decrease bacterial

levels in a small

number of studies

with a small number

of participants

Schubert V. Effects of

phototherapy on pressure

ulcer healing in elderly

patients after a falling

trauma. A prospective,

randomized, controlled study.

Photodermatol

Photoimmunol Photomed.

2001;17(1):32-8.

Pressure ulcers

Prospective RCT

N = 74 Normalized ulcer area vs. time;

Time-averaged healing rate

Significantly faster healing

rates in treatment group

Homogenous group by

age

Thai TP, Keast DH, Campbell

KE, Woodbury MG, Houghton

PE. Effect of ultraviolet light C

on bacterial colonization in

chronic wounds. Ostomy

Wound Manage.

2005;51(10):32-45.

Pre-test, post-test

UVC treatment

study

22 individuals with

chronic wounds including

pressure ulcers (n = 7)

equal number of men

and women

elderly subjects

Baseline control comparison

Results of this study also suggest

that a single 180-second treatment

of UVC was able to kill bacteria,

including antibiotic-resistant

bacteria such as MRSA, present in

all types of chronic superficial

wounds, including pressure,

diabetic, venous, and arterial

ulcers. However, findings from this

study suggest that the response to

UVC may be dependent on the

type and relative amount of

bacteria present initially in the

wound bed.

A statistically significant

reduction of predominant

bacteria was noted

following a single UVC

treatment (P <0.0001, n =

22) (see Figure 3).

Furthermore, significant

reductions of MRSA (P

<0.05), S. aureus (P <0.01),

and other types of bacteria

(combination of P.

Pseudomonas aeruginosa

and Streptococcus group B

and G, (P <0.05) were

noted.

Did not meet the

criteria for inclusion (7

subject clinical study)


127

Acoustic Energy (Ultrasound) Reference Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Ellis SL, Finn P, Noone M,

Leaper DJ. Eradication of

methicillin-resistant

Staphylococcus aureus from

pressure sores using warming

therapy. Surg Infect.

2003;4(1):53-5.

RCT

N =33; 23 completed 4

weeks; 16 completed 8

weeks of study

Warming Therapy Bacterial cultures; semi-

quantitative swabs

Reduction of MRSA in IR-

treated group; no

difference in healing rates

Small sample size; large

number of withdrawals

and drop outs

Ennis WJ, Valdes W, Gainer

M, Meneses P. Evaluation of

clinical effectiveness of MIST

ultrasound therapy for the

healing of chronic wounds.

Adv Skin Wound Care.

2006;19(8):437-46.

Prospective Non-

comparative

clinical outcomes

trial

Mixed chronic (> 4

weeks)

recalcitrant

wounds of lower

extremity;

matched for

demographics of

size and ulcer

duration; by % of

number in each

group with

comorbidities

listed. Only 1

patient with PrU

in current study;

46 in historic

study ; Mean

value for baseline

TCPO2 = 30%;

N=23 with 29 wounds;

Historic controls N=122

Low FQ MIST (40kz) followed by

Moisture retentive dressing; Length of

treatment time varied depending on

size of ulcer from 3x/week;

debridement PRN ; MIST assisted

therapy ( MIST treatment followed by

a subsequent treatment ( e.g. ES or

MHZ US)

Mixture of ES, MHz US, or

combination of the 2

Current study: overall

Healed Mist Only 31%

(N=9). Mist Assisted

37.9% (N=11).

Not Healed: 20.7% (N=6)

Historic study: Over all

healing with PrU: 64.7 %

(N=33/157) ( this does not

match the number of

historic controls; not

explained)

Validated measurements

and statistical methods

were used

No conclusion can be

Reached specific to PrU

healing. MIST appears

to improve healing of

chronic wounds. Trend

is that this can be

applied to PrU as well

as other chronic

wounds with expected

good outcomes.

Ennis WJ, Foremann P, Mozen

N, Massey J, Conner-Kerr T,

Meneses P. Ultrasound

therapy for recalcitrant

diabetic foot ulcers: results of

a randomized, double-blind,

controlled, multicenter study.


2005;51(8):24-39.

Prospective DB

RCT

Diabetic Foot

Ulcers

Treatment=27

Control=28

Low FQ MIST ( 40 khz) + SWC 4

minutes 3x/week for 12 weeks or until

closed

SWC MIST group had a 40.7%

closure rate vs. 14.3%

closure for controls;

diminished exudate in

treatment group not in

controls

Well- designed study.

Shows improved

healing with low fq US

Not a PrU study but

trend supports

improved healing with

Lo FQ US for chronic

diabetic ulcers


128


Length of Follow-up

Results Limitations

Johannsen F, Gam AN,

Karlsmark T. Ultrasound

therapy in chronic leg

ulceration: a meta-analysis.

Wound Repair Regen.

1998;6(2):121-6.

RCT

6 studies of US

effect of healing

on chronic leg

ulcers

6 studies 1MHz, 3Mhz and 30khz; different

intensities used; time 5-10 min

3x/week. 3 delivered peri-wound 3, 1

surface, 1 both.

Not reported Greater % of ulcers treated

with US healed compared

to controls

Significant effect of US

on venous ulcers

demonstrated. Best

response noted from

low FQ 30kHz

Kavros SJ, Miller JL, Hanna

SW. Treatment of ischemic

wounds with noncontact,

low-frequency ultrasound:

the Mayo clinic experience,

2004-2006. Adv Skin Wound

Care. 2007;20(4):221-6.

Prospective ,

parallel group RCT

Non-healing leg

and foot ulcers

associated with

chronic critical

limb ischemia

MIST N=35; controls

N=35

Low FQ MIST (40Khz) + SWC ; 3x/week

x 12 weeks

Standard Wound Care (SWC) 63% of MIST group

achieved >50% healing in

12 weeks vs. controls 29%

( P<.001) ; measurement

technique subject to

human error; TcPO2

<20mm Hg at baseline

healed <50% during trial

Addition of MIST

statistically improved

healing of chronic

ischemic leg ulcers.

Study well designed ;

application to PrU

healing is probable not

proven

Also not proven: effect

on wound pain or

bacterial burden

Nussbaum EL, Biemann I,

Mustard B.Comparison of

ultrasound/ultraviolet-C and

laser for treatment of

pressure ulcers in patients

with spinal cord injury. Phys

Ther. 1994;74(9):812-23.

Also see phototherapy

Small RCT

a control group

(n = 9), a US/UVC group

(n = 5), and a laser group

(n=6).

20 patients

Spinal cord unit/hospital

Combined therapy of ultrasound

and UVC with standardized wound

care for individuals with pressure

ulcers resulted in faster healing

times than standardized wound

care combined with laser.

Results showed that

USIWC treatment had a

greater effect on wound

healing than did nursing

care, either alone or

combined with laser.

Ultrasound-ultraviolet-C

may decrease healing time

and may allow faster

return to rehabilitation

program, work, and leisure

activities for patients with

spinal cord injury who

have pressure ulcers.

Difficult to draw

conclusion as 2

treatment types

combined and

compared against laser

However, U/S has been

shown to enhance

healing in a number of

studies (10) in chronic

wounds and UVC has

been shown to enhance

healing and decrease

bacterial levels in a

small number of studies

with a small number of

participants

ter Riet G, Kessels AG,

Knipschild P. A randomized

clinical trial of ultrasound in

the treatment of pressure

ulcers. Phys Ther.

1996;76(12):1301-11.

RCT

Pressure ulcers:

16 Stage IV

72 lesser stage II

& III;

Stage II ulcers had

Treatment=45

Control=43

Sham US;

Cleansing: NS or chlorhexidine 0.1%

3.28 MHz ; SATA intensity 0.1 W/cm2 ;

treatment to wound edge and wound

bed (cover with Tegaderm and fill

volume with NS to transmit US)

Cleansing: NS or chlorhexidine 0.1%

Wound healing (rate & closure) Measurements: closure

rates: 0.18 mc2 / week for

US group; 0.31 cm2 /week

sham.

Points based on subjective

evaluation: US .71

points/week; sham .46

points/week

Study limitations: PrU

studied included ulcers

of mixed stages

Unspecified number

also received antibiotic

(ATB) therapy for

infection.

Many patients were

critically ill in both

groups resulting in 15


129


Length of Follow-up

Results Limitations

not healed in prior

7 days

All ulcers located

on trunk.

deaths from non-

treatment related

causes.

Conclusion: cannot

demonstrate significant

beneficial effects for

infected or clean PrU

but treatment group

showed some better

clinical outcomes

Comment: due to

mixed stages, critically

ill elderly patients and

use of ATB and

Chlorhexidine for some

patients, this study has

significant flaws.

Whitney JD, Salvadalena G,

Higa L, Mich M. Treatment of

pressure ulcers with

noncontact normothermic

wound therapy: healing and

warming effects. J Wound


2001;28(5):244-52.

Pressure ulcers

Prospective, RCT

N = 40; 29 completed

study

PSST Significantly faster rates of

healing with IR-modality

Small sample size

Negative Pressure Wound Therapy Reference Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Ford CN, Reinhard ER, Yeh D,

Syrek D, De Las Morenas A,

Bergman SB, et al. Interim

analysis of a prospective,

randomized trial of vacuum-

assisted closure versus the

healthpoint system in the

management of pressure

ulcers. Ann Plast Surg.

2002;49(1):55.

Prospective

randomized trial

6 weeks duration

Clinic staff blinded

to study group

3 patients with 3

wounds crossed

over to other

treatment

28 patients with 41 full

thickness PrU present

for 4 weeks were

recruited to randomized

to NPWT to an

antimicrobial

(Cadexomer iodine (CXId)

with amorphous or

sheets) for wounds with

exudate or Panafil for

clean ulcers

Prior to the study, subjects had CBC,

ESR, albumin, photograph, soft tissue

biopsy, plaster wound impression,

wound size, bone biopsy and culture

and MRI to rule out osteomyelitis if

needed. If osteomyelitis present had 6

weeks of antibiotics

All wounds were débrided surgically if

needed, no other debridement was

done

Subjects seen at 3 & 6 weeks,

3 weeks:

Photograph, plaster wound

impression and measurements

6 week: photograph, soft tissue

biopsy, plaster wound impression,

and measurements

Also had bone biopsy and MRI if

done prior

Follow-up ranged 3-10 months

22 patients with 35 ulcers

completed the trial. 3

patients lost to follow-up,

1 noncompliant, 2 patients

died

Age of sample:

NPWT mean age 41.7

years Cadexomer mean

age 54.4 years

Ulcer distribution:

Ischial = 9

Exclusion criteria were

extensive, sample was

unlike most PrU patients

Study was of all wounds

not of subjects

Subject burden was

extensive

Ulcer infection is a major

healing deterrent and


130


Length of Follow-up

Results Limitations

Inclusion criteria:

Albumin2.0, age 21-80,

ulcer volume 10-150 ml

measured by plastic

wound impression

Exclusion criteria

Fistula, cancer,

pregnancy. lactation,

Graves’ disease, iodine

allergy, burns, sepsis,

uncontrolled DM,

orthopedic hardware,

renal or pulmonary

disease, use of steroids

NPWT dressings changed MWF

(manufacture recommends every 48

hours), Iodosorb dressings changed

once or twice daily (manufactured

recommends twice weekly dressing

changes)

Sacral = 17

Lateral malleolar = 4

Trochanteric = 1

Heel =4

2 ulcers in each group

healed completely ; 1

patient needed

amputation

6 of the NPWT and 6 of

CXId/Panafil group had

flap surgery

Mean reduction in wound

volume

NPWT = 51.8%

CXid = 42.1%

(p = 0.046)

Mean reduction in length

NPWT = 36.9 cm

CXid = 18.7 cm

(p = 0.10)

Mean reduction in width

NPWT = 40.0 cm

CXid = 19.0 cm

(p =0.11)

Mean reduction in depth

NPWT = 33.6 cm

CXid = 31.0 cm

(p = 0.90)

15/35 wounds were

suspicious for

osteomyelitis and 3

positive by biopsy and 10

positive by MRI imaging

PMN count

NWPT = -37.0

CXId = +22.7

(p = 0.13)

Lymphocytes

NPWT = -6.2

CXId = +45.0

(p = 0.41)

this study did not

distinguish which ulcers

received iodine or

Panafil. The PMNs

decreased in NPWT

group, but this could also

be due to management

of systemic infections

beyond wound

infections.

There were actually 3

groups in this study, but

the Panafil and CXId

groups were reported as

1 group

This study had excellent

measures of healing, but

violated some basic

principles of research.


131


Length of Follow-up

Results Limitations

No difference in capillary

numbers in either group

3 wounds in NPWT

showed improved

osteomyelitis

CXId wounds (N not

stated) showed no

improvement in

osteomyelitis by biopsy or

MRI (p =0.25)

Joseph E, Hamori CA,

Bergman S, Roaf E, Swann NF,

Anastasi GW. New

therapeutic approaches in

wound care. A prospective

randomized trial of vacuum-

assisted closure versus

standard therapy of chronic

nonhealing wounds. Wounds.

2000;12(3):60-7.

Prospective

randomized trial

comparing NPWT

to wet to moist

gauze dressings

covered with a

thin film to

simulate closed

therapy without

suction


wounds (N = 28/ 36

wounds were PrU or

79%)

12 men and 12 women

Inclusion Criteria

Wounds over 4 weeks

duration without signs of

healing or closure

Exclusion Criteria

Infection (UTI,

pneumonia, wound)

Albumin < 3.0

Uncontrolled DM, HPT,

thyroid, renal or lung

disease

Immunosuppressive

Pregnancy or breast

feedings

Osteomyelitis by bone

biopsy

Cancer, fistula (stomal or

rectal)

Likely to be cooperative

All patients were offered

surgical closure of any

remaining wounds

All débrided if needed 48 hours prior to

treatment

NPWT dressings changed every 48

hours

WMG changed 3 times per day and

kept continually moist with NS

All patients were given zinc, MVI and

nutrition

All placed on therapeutic sleep

surfaces

Wound measurements , photos,

alginate impressions, blood tests

and biopsy and culture of wounds

at 3 and 6 weeks

Measurement of

dressing , edema, erythema

exposed bone or tendon

18 wounds were

randomized to treatment

group, each wound was

randomized. 3 patients

had wounds with both

therapies

21% (N =5) required acute

care (previous locale

unknown); 38% (N =9) in

LTC, 42% (N=10) home

care

Group comparison

Age (p = ns)

NPWT mean 56

WMG mean 49

Gender (% Male) (p = ns)

NPWT 66%

WMG 44%

Wound depth (% change

in depth)

NPWT = 66%

WMG = 20%

(p 0.00001)

Wound length (% change

in length)

NS change (no detail

provided)

Wound width (% change in

width)

Actual numbers not

given

(p 0.02)

Nice attempt to mimic

NWPT in this study

Were the NPWT the

same pump

Inflammation was

increased in WMG even

though no infection

present at start of

therapy

Study looked at ulcers

not patients; but did

randomize study groups

by wounds

2 patients had calcaneal

fractures due to DM and

ambulating while

wearing NPWT.

Eventually required

amputation for

osteomyelitis


132


Length of Follow-up

Results Limitations

Initial wound volume

NPWT = 38 cc

WMG = 24 cc

Wound volume (% change

in volume)

NPWT = 78%

WMG = 30%

(p 0.038)

Histological differences in

groups

WMG = 81%

inflammation and fibrosis

NPWT = 64% granulation

tissue

Complications after RX

began

(infection/osteomyelitis,

fistula)

WMG = 44% (N=8)

NPWT = 17% (N =3)

( p 0.0028)

Philbeck TE, Jr., Whittington

KT, Millsap MH, Briones RB,

Wight DG, Schroeder WJ. The

clinical and cost effectiveness

of externally applied negative

pressure wound therapy in

the treatment of wounds in

home healthcare Medicare

patients. Ostomy Wound

Manage. 1999;45(11):41-50.

Retrospective

record review (N

=1262) of KCI

records for

qualification for

therapy in

patients who had

failed prior

interventions.

Data were

complete on 1032

records which was

more than 17,000

data entries

Stage III PrU = 183

Stage IV = 383

43 PrU were located on

trunk and trochanter

(stage III

and IV)

Data taken from records Wound age

Wound location

Prior dressings

Wound description

(color, dressing type odor and

amount)

Support surface

Reason for stopping NPWT

Wound healing rate computed

(cm2/day)

Wound volume (cm3/day)

Wound volume change (cm3/days)

All wounds (N =1170)

Sacrum = 198 (16.9%)

Ischia = 167 (14.3%)

Trochanter = 72 (6.2%)

Leg wounds not included

since etiology is mixed, but

is likely 58 (495 – 437 = 58)

495 patients with pressure

ulcers were placed on a

pressure reduction surface

(566 patients possible)

PrU healing rate = 0.23

cm2 /day

Healing rates were

compared to Ferrell’s

work (1984) (He found 84

patients with PrU healed

at 0.090 cm2 per day).

This study estimated that

using an average ulcer

size of 22.2 cm2, would

require 97 days to heal

using NPWT and

compares healing in

Ferrell’s work estimating

time to heal at 247 days.

Wanner MB, Schwarzl F,

Strub B, Zaech GA, Pierer G.

Vacuum-assisted wound

closure for cheaper and more

comfortable healing of

Prospective RCT 22 SCI patients with

pelvic pressure ulcers

compared to dressings

with Ringer’s dressing

(wet to dry or wet to

Surgical debridement for all subjects,

treatment on day 2

Wet to dry dressings until granulation

tissue, then changed to wet to moist

Wound volume measured with NS

insertion into wound (reliability

confirmed)

End point = wound volume

Group comparison

Age p = NS

NPWT = 49 (25-73)

Dressing = 53 (34-77)

Gender p = NS

Study compared absolute

initial wound volume

They questioned the

change in prior wound

volumes to be an


133


Length of Follow-up

Results Limitations

pressure sores: a prospective


Surg Hand Surg.

2003;37(1):28-33.

wet)

When wound volume

reduced by 50%, all

patients closed with flaps

and dressings kept moist

NWPT (continuous pressure of -125

mm HG) with dressings changed at 2-7

days

All patients prone, on air fluidized bed

or air bed

reduced by 50% NPWT = 7 males

Dressings = 8 males

Initial mean wound

volume p = NS

NPWT = 50 (3-132)

Dressing = 42 (5-68)

Mean days to 50%

reduction in wound

volume

NPWT = = 27 days (SD 10

days)

Dressing = 28 days (SD 7

days)

Granulation tissue

formation equal in both

groups

mechanical effect of

NPWT pulling on wound

edges

What was the effect of

the Ringer’s over Normal

saline used in most

wound care?

Oxygen Therapies Reference Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Edsberg LE, Brogan MS,

Jaynes CD, Fries K. Topical

hyperbaric oxygen and

electrical stimulation:

exploring potential synergy.


2002;48(11):42.

Also see hyperbaric oxygen

Pressure ulcers

Prospective,

uncontrolled

N = 8 Enhanced wound closure with

topical HBO and topical HBO &


No significant difference

between topical HBO

alone and topical HBO

with electrical stimulation

Larger, controlled study

to determine efficacy

needed

Recommendation based

on data from all chronic

wound types


134

Table 11. Growth Factors for Pressure Ulcer Treatment References Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Hirshberg J, Coleman J,

Marchant B, Rees RS.

TGF-beta3 in the


ulcers: a preliminary

report. Adv Skin

Wound Care.

2001;14(2):91-5.

Evidence level = II

Randomized, blind,

parallel, placebo-

controlled trial (pilot

study)

N = 14 patients (6

women and 8 men) –

subset of the 270 study

participants

Each group received once

daily application of a topical

agent; Group 1 (N=4)

received 1.0 µg/cm² TGF-β3;

Group 2 (n = 5 received 2.5

µg/cm² TGF-β3 and Group 3

(N = 5) received placebo – the

topical agent ulcer in

conjunction with

standardized wound care for

16 weeks or until the ulcer

was healed

Reduction in pressure ulcer area

and volume

Only 8 patients completed the study; when

comparing group 3 with group 2

represented a significant reduction in the

mean relative surface area (p <.05); a

significant decrease in volume was seen

when comparing group 1 with group 3

(p<.05); the mean relative surface areas of

the target Pus at the termination of the trial

were as follows: Group 1 = 0.3 cm²; Group 2

= 0.4 cm² and Group 3 = 0.7 cm²; the mean

relative volumes at termination were as

follows: Group 1 = 0.7cm³, Group 2 = 0.2cm

³ and Group 3 = 0.3cm³ - the use of topical

growth factors is a progressive adjuvant to

the traditional treatment of Pus. The

potential benefits of growth factors include

faster closure rates, ease of application and

minimal adverse effects

Small sample size; 43%

of the patients did not

complete the trial; a

larger multicenter

blinded study is

required to explore the

potential benefits

Landi F, Aloe L, Russo

A, Cesari M, Onder G,

Bonini S, et al. Topical

Treatment of Pressure

Ulcers with Nerve

Growth Factor. Ann

Intern Med.

2003;139(8):635.

Evidence level = II

Randomized, double-

blind, placebo-

controlled trial

N = 36 patients with

PrU of the foot

Baseline assessments were

done before randomization

during the first 2 weeks after

nursing home admission; 18

patients received 2.5S murine

nerve growth factor

treatment and 18 patient

received only conventional

topical treatment (balanced

salt solution) – 6 week

follow-up

Surface area – course of the

ulcers was evaluated by tracing

the perimeter of the wound

onto sterile transparent block

paper and determining the

stage

After 6 weeks the mean area (± SD) of the

ulcers in the treatment group was 274 ±

329 mm² compared with 526 ± 334 mm² in

the control group (P = 0.022); reduction in

the PU area was 738 ± 393 mm² in the

treatment group and 485 ± 384 mm² in the

control group (P = 0.034); all of the ulcers

that were treated with topical application of

nerve growth factor showed a statistically

significant acceleration of the healing

process

Further studies are

warranted to better

understand the benefit

of topical nerve growth

factor treatment in


skin ulcers

Mustoe TA, Cutler NR,

Allman RM, Goode PS,

Deuel TF, Prause JA, et

al. A phase II study to

evaluate recombinant

platelet-derived

growth factor-BB in

the treatment of stage

3 and 4 pressure

ulcers. Arch Surg.

1994;129(2):213-9.

Evidence level = II

Prospective,

randomized, double-

blind trial

N = 44 completed the

study

N = 15 100 µg/ml aqueous

rPDGF-BB; N = 12 300 µg/ml

aqueous rPDGF-BB or

placebo (N = 14) and all

groups received saline gauze

dressings were applied daily

in addition to frequent

turning

Serial volume measurements of

the healing wounds were taken

using alginate molds

The ulcers in the placebo group remained at

83%of the initial ulcer volume at day 29 of

the active-treatment phase while the ulcers

in the 100 - µg/ml and the 300 - µg/ml

treatment groups achieved 29% and 40% of

the initial volume respectively

Small sample size;

potential confounder in

the interpretation of the

results is the loss of 8

patients who did not

complete the active-

treatment phase and

three patients without

determinations of day

29 ulcer volume;


135


Length of Follow-up

Results Limitations

Pierce GF, Tarpley JE,

Allman RM, Goode PS,

Serdar CM, Morris B,

et al. Tissue repair

processes in healing

chronic pressure ulcers

treated with

recombinant platelet-

derived growth factor

BB. Am J Pathol.

1994;145(6):1399-410.

Indirect evidence

Multicenter,

randomized double-

blinded trial

N = 20 Patients were treated with

either placebo, rPDGF-BB

(100 µg/ml(1µg/cm²) or 300

µg/ml (3µg/cm²)) for 28 days;

3 mm full thickness punch

biopsies were collected

before treatment on day 0

and on days 8, 15, and 29

from approximately half of

the patients in the clinical

trial – biopsies were collected

for light microscopy at all

time points and Masson’s

staining was done on each

biopsy to evaluate fibroblast

content and size, neovessel

formation and collagen

staining, photomicrographs

of both Masson trichome and

Sirius red stains were taken

of all biopsies, sections were

also stained with an antibody

to the N-terminus of the type

I procollagen molecule

Volumetric and planmetric

measurements were obtained

weekly and were used to

determine whether ulcers were

healing or nonhealing

10 of the 13 ulcers in the treatment groups

were healing compared with 4 of 7 placebo-

treated ulcers; increase in fibroblast content

was detected in all rPDGF – BB treated

ulcers compared with placebo (2.81 ± 0.17

versus 2.05 ± 0.24, P = 0.01)

Small sample size

Rees RS, Robson MC,

Smiell JM, Perry BH.

Becaplermin gel in the


ulcers: a phase II

randomized, double-

blind, placebo-

controlled study.

Wound Repair Regen.

1999;7(3):141-7.

Evidence level = I

(also information in

this article related to

adverse event

including skin

ulceration; urinary

tract infection; skin

disorder etc. –did not

include this data here)

Prospective,

multicenter, double-

blind, parallel group,

placebo-controlled

trial

N = 124 (20 women;

104 men) – all

participants had to have

at least 1 but no more

than 3 chronic full

thickness (stage III or

IV) PUs

Before randomization the

target ulcer was debrided to

remove all nonviable tissue;

patients were randomly

assigned to 1 of 4 parallel

treatment groups: 1)

becaplermin gel 100 µg/g of

sodium

carboxymethylcellulose

vehicle gel (N = 31) once daily

alternating with placebo gel

every 12 hours; 2)

becaplermin gel 100 µg/g (N

= 30) once daily alternating

with placebo gel every 12

hours; 3) becaplermin gel 100

µg/g twice daily (N = 30) or 4)

placebo gel (N = 31) twice

daily; a thin layer of gel was

placed on the entire exposed

wound surface and the

Relative ulcer volume – ulcer

volume at the end of the study

divided by the ulcer volume at

baseline; baseline volume

effect; complete healing

In the groups treated with either dose of

becaplermin gel once daily, the incidence of

complete healing was significantly greater

compared with that of placebo gel (23% and

19% for the 100 µg/g and 300 µg/g

becaplermin gel treatment groups

respectively, vs. 0% for the placebo gel

treatment group, p = 0.005 and p = 0.008

respectively); a similar difference was

observed in the incidence of ≥ 90% healing:

58% and 59% for the 100 µg/g and 300 µg/g

becaplermin gel treatment groups,

respectively, vs. 29% for the placebo gel

treatment, p = 0.021 and p = 0.014

respectively; the incidences of complete and

≥90% healing were 3% and 40%, respectively

in patients receiving becaplermin gel 100

µg/g twice daily; the median relative ulcer

volume at endpoint was 0.07 and 0.05 in the

becaplermin gel 100 µg/g and 300 µg/g

treatment groups, respectively compared by

Future studies are

warranted to address

issues such as effect of

becaplermin gel on

healthcare resource

utilization and patient

quality of life


136


Length of Follow-up

Results Limitations

wound was packed with

saline-moistened gauze; all

study sites received dressing

supplies to ensure a uniform

regimen; the second dressing

change occurred in a similar

fashion after rinsing the

wound surface with saline or

water; debridement of ulcers

to remove fibrin and necrotic

tissue was an important

component of good wound

care and was performed by

investigators during clinic

visits if necessary

the 0.27 in the placebo gel group (p = 0.013

and p = 0.011) respectively; median relative

ulcer volume at endpoint was 0.15 in the

group receiving becaplermin gel 100 µg/g

twice daily

Robson MC, Phillips

LG, Thomason A,

Robson LE, Pierce GF.

Platelet-derived

growth factor BB for

the treatment of

chronic pressure

ulcers. Lancet.

1992;339(8784):23-5.

Evidence level = II

Randomized, phase

I/II, double-blind,

placebo-controlled

study

N = 20 – each

participant had a stage

III or IV ulcer of area 25

– 95 cm²

Each participant was

randomly assigned to a

placebo group or rPDGF-BB

at 1 µg/ml and 10 µg/ml or

100 µg/ml; eligible

participants underwent

complete screening before

treatment; if debridement

was necessary the drug was

administered 48 hours later

Volume measurements of

pressure ulcers with alginate

molds were done on days 0, 7,

14, 21 and 29; other

measurements including

maximum depth crater, area of

ulcer opening and histology of

biopsy samples

There were no significant differences in

ulcer volume at 29 days among patients

treated with 1 µg/ml and 10 µg/ml rPDGF-

BB or placebo; the 5 patients treated with

100 µg/ml rPDGF-BB had a better healing

response than the 7placebo – treated

patients; the mean (SE) volume of the ulcer

on day 29 was 6.4 (4.0)% of day 0 volume in

the rPDGF-BB treated patients compared

with 21.8 (5.6)% in the placebo-treated

patients (p = 0.12); histological examination

of biopsy samples from the ulcers showed

normal active wound-healing processes in all

groups, with no consistent differences in

cellular influx or extracellular matrix

deposition – However, the 100 µg/ml

rPDGF-BB group tended to have a greater

fibroblastic and endothelial cell influx and

consequently more provisional extracellular

matrix and new vessels

None listed

Robson MC, Phillips

LG, Thomason A,

Altrock BW, Pence PC,

Heggers JP, et al.

Recombinant human

platelet-derived

growth factor-BB for

the treatment of

chronic pressure ulcers

[see comments]. Ann

Randomized, phase

I/II, double-blind,

placebo-controlled

study

N = 20 - each

participant had a stage

III or IV ulcer of area 25

– 95 cm²

Each participant was

randomly assigned to a

placebo group or rPDGF-BB

at 1 µg/ml and 10 µg/ml or

100 µg/ml daily for four

weeks – immediately before

application of the test

material each day the wound

was gently cleansed with

saline and then blotted dry

Hematology, serum chemistry

and urinalysis values were

evaluated on days 0, 3, 7, 14, 21

and 29 – measurements of the

pressure ulcer were performed

on days 0, 7, 14, 21, and 29

using maximum perpendicular

diameters of the surface and

maximum depth of the crater –

after discontinuation of

There was no clinically relevant differences

between patients treated with 1 µg/ml or 10

µg/ml rPDGF – BB or placebo in the

percentage of initial depth or volume

measured over time – the placebo and 1 and

10 µg/ml patients demonstrated

unexpectedly high rates of healing during

the trial however the 100 µg/ml of rPDGF –

BB had ulcers of clinically similar duration

and had a healing rate that was markedly

Small group size;

expanded trials are

warranted to determine

if these observations

are confirmed in larger

numbers of patients

having pressure ulcers


137


Length of Follow-up

Results Limitations

Plast Surg.

1992;29(3):193-201.

Evidence level = II

with a sterile gauze; after

application, the wound was

left open for 15 minutes to

permit absorption of rPDGF-

BB to the wound surface

treatment patients were

discharged and evaluated at 2

weeks and 1, 2, 3, and 5 months

greater than that observed in the other

treatment groups; the depth of the ulcer on

day 29 was 14.1 ± 7.4% of the day 0 depth in

the 100 µg/ml – treated patients compared

with 34.9 ± 6.7% in the placebo-treated

patients; the 100 µg/ml group had an overall

two-fold decrease in ulcer depth

throughout the treatment period compared

with all other groups; treatment differences

were found between the 100 µg/ml dose

group and placebo and 10 µg/ml groups (p ≤

0.05); the volume of the ulcer on day 29 for

the 100 µg/ml treated patients was 6.4 ±

4.0% of the day 0 volume compared with

21.8 ± 5.6% in the placebo-treated patients;

overall differences in the percentage of

initial volume between groups were not

statistically significant (p = 0.16); however

the data from the 100 µg/ml demonstrated

1.6 to 2.2 fold decreases in overall volume

throughout the treatment period; 2 patients

in the 100 µg/ml group received complete

healing

Robson MC, Abdullah

A, Burns BF, Phillips

LG, Garrison L, Cowan

W, et al. Safety and

effect of topical

recombinant human

interleukin-1beta in

the management of

pressure sores. Wound

Repair Regen.

1994;2(3):177-81.

Evidence level = II

Prospective,

randomized, blind,

placebo-controlled

trial

N = 26 patients entered

the study and 24

patients completed the

study with pressure

sores extending from

the bone to the

subcutaneous tissue

(stage III – IV)

The volume applied was

based on the volumetrically

determined surface area; .01

ml/cm² which was measured

at baseline and then adjusted

weekly; the contents of the

drug were delivered by a

spray bottle after cleansing

with Normal Saline; the

wound was air0dried and a

saline solution-moistened

gauze dressing was applied

and changed 12 hours later;

three dosage tiers were

completed in groups of 8

patients (6 actively treated

and 2 treated with placebo

per dose); the dose levels

were: Tier 1: 0.01

µg/cm²/day; Tier 2: 0.1

µg/cm²/day; Tier 3: 1.0

µg/cm²/day

Measurements of the pressure

ulcer were performed on days 0,

7, 14, 21, 29 and at 1 and 3

months after drug application;

each ulcer received treatment

until it healed or for a maximum

of 28 days

No dose adjustments were required and no

patient required discontinuance of the drug

because of toxicity; no statistical difference

was found between initial sizes in the

placebo and the rhu IL-1β- treated groups;

no statistical significant differences were

seen in the percentage decreases in wound

volumes over the 29- day treatment

evaluation period were compared among

the various dosage groups or vehicle

placebo;

None listed


138


Length of Follow-up

Results Limitations

Robson MC, Hill DP,

Smith PD, Wang X,

Meyer-Siegler K, Ko F,

et al. Sequential

cytokine therapy for

pressure ulcers: clinical

and mechanistic

response. Ann Surg.

2000;231(4):600-11.

Evidence level = I

A masked,

randomized pressure

ulcer trial

N = 61 inpatient’s

completed the 35-day

acute phase of the trial

with pressure ulcers

involving any tissue

from a bony

prominence to the

subcutaneous tissue

(grade III/IV)

Each of the patients were

randomized to one of four

treatment regimens: N = 15

received 2.0 µg/cm² GM-CSF

topically applied daily for 35

days; N = 15 received 5.0

µg/cm² bFGF topically

applied daily for 35 days; N =

16 received 2.0 µg/cm² GM-

CSF applied for 10 days

followed sequentially by 25

days of topically applied 5.0

µg/cm² bFGF; or the N = 15

received comparative

placebos applied for 35 days

– the amount of topical

substance for each week of

treatment was based on a

volumetrically determined

surface area at baseline and

on study days 7, 14, 21, and

28

The pressure ulcer was

measured on day 0 and weekly

for 5 weeks using planimetry of

the ulcer opening and volume

determination using alginate

molds;

Day 0 Ulcer Volume (cm³)

Mean ± SD/Median (range)

- All patients (N = 61) :

37.49 ± 30.59/26.37(9.82-153.72)

- GM-CSF (N = 15):

32.77 ± 21.06/27.52 (10.27-83.01)

- bFGF (N = 15)

33.81 ± 26.12/23.54 (9.82-100.35)

- Sequential GM-CSF/bFGF (N = 16)

38.16 ± 38.3/25.88 (10.00-153.72)

- Placebo (N = 15)

45.19 ± 34.79/41.15 (10.44-116.73

P-Value for Median = 0.84

Day 36 Ulcer Volume (cm³)



12.65 ± 16.24/7.26 (0.22-99.65)

- GM-CSF (N = 15):

12.02 ± 11.88/9.29 (0.88-40.62)

- bFGF (N = 15)

7.24 ± 6.11/4.42 (0.22-20.80)


16.83 ± 25.75/7.48 (0.22-99.65)

- Placebo (N = 15)

14.24 ± 13.66/8.85 (2.12-45.84)


% Wound Closure on Day 36



70 ± 19/73 (3-99)

- GM-CSF (N = 15):

67 ± 24/70 (3-93)

- bFGF (N = 15)

75 ± 19/79 (42-99)


68 ± 21/73 (29-98)

- Placebo (N = 15)

71 ± 11/72 (39-84)


When patients receiving any cytokine

None listed


139


Length of Follow-up

Results Limitations

therapy were compared with patients

receiving placebo vehicles, significantly

more patients treated with cytokine

achieved a more than 85% decrease in ulcer

volume (P = .03); the bFGF-alone group had

significantly more patients than the placebo

alone group with more than 85% closure (P

= .02) and more than 90% closure (P = .04;

the sequential cytokine therapy reached a

significance level of P = .10 compared with

placebo at more than 85% healing; the

patients treated with GM-CSF alone did not

respond significantly better than placebo-

treated patients at more than 85% closure

(P = 0.22)


140

Table 12. Surgery for Pressure Ulcers Direct Evidence Reference

Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Akan IM, Ulusoy MG,

Bilen BT, Kapucu MR.

Modified bilateral

advancement flap: the

slide-in flap. Ann Plast

Surg. 1999;42(5):545-

8.

Between 1995 and

1997 10 patients

received this revised

V-Y advancement

flap design.

Age range was 5 – 70

years, and follow-up

ranged from 6 – 12

months. Defect size


cm. Defect locations

were sacrum (7), and

one each on hand,

thigh, and forehead.

Five defects were

pressure sore

related, 2 were from

basal cell carcinoma,

two from

meningomyelocele

and the youngest

was from a skin

defect.

Case Reports The standard V-Y flap design

was modified somewhat with

the height of the V flaps

measuring 1.5 – 2 times the

diameter of the defect. The

limbs of the flap were curved

outward slightly making the

flap and its two extensions

broader than the standard V-

Y flap. Both upper and lower

extensions of the V flap were

then pulled into position and

sutured to the concave base

of the Y flap. The limbs of

the Y flap were sutured to

the outside of the two V flaps

respectively, and the V flaps

were sutured together in the

center.

All wounds closed successfully,

without necrosis or wound

dehiscence.

No statistics given, but successful repair and

healing of all defects resulted.

Efficient redistribution

of available tissue by

the combined use of

transposition and

advancement

principles resulted in

the repair of relatively

large skin defects with

reduced tension along

the closure.

Ao M, Mae O, Namba

Y, Asagoe K.

Perforator-based flap

for coverage of

lumbosacral defects.

Plast Reconstr Surg.

1998;101(4):987-91.

Lumbosacral defects

on 20 patients were

covered with a

perforator-based flap

between December

1995 to January

1997. 10 males and

10 females, age

range 31 – 95 years.

Defect size ranged

from 5 X 5 cm to 11 X

17 cm. No average

given.

Case Reports Shape and size of the donor

flap depended on size of

defect. Also harvest site

depended on location of

defect. Perforator-based

flaps were used rather than

musculo-cutaneous flaps as

to preserve the muscle tissue

intact, and in case of repeat

sore to leave that option

open for a repeat surgery.

Pressure sore coverage and flap

healing in all cases.

No statistics were given. One had a minor

fistula, one partial necrosis, two had

marginal necrosis, and one had infection. All

survived and healed.

Authors showed a

variety of flap design is

possible, such as tri-

lobed, quadric-lobed,

step-ladder fashion,

fusiform, or elliptical.

Advantages are rich

vasculature to

facilitate transfer by

means of large flap

based on one or

several perforators

compared with

conventional skin

flaps. Adaptability of

flap design to defect,

easy donor site skin

closure not requiring


141

Reference


Length of Follow-up

Results Limitations

skin grafting, and non-

sacrifice of underlying

muscle.

Aslan G, Tuncali D,

Bingul F, Ates L, Yavuz

N. The "duck"

modification of the

tensor fascia lata flap.

Ann Plast Surg.

2005;54(6):637-9.

27 patients with

trochanter pressure

sores treated for

total of 31 flaps. 15

Right sided, 16 left

sided, 4 bilateral.

Average age 51 years

(range 19 – 76). All

patients either

quadriplegic (8) or

paraplegic (19).

Average defect

requiring coverage

was 11 X 9 cm (range

9 X 7 to 14 X 11 cm).

Case Reports The “duck beak” modification

of the tensor fascia flap is

used to transition the closure

of the flap harvest site to the

flaps new location. Drains

inserted and removed day 3.

Successful covering of all 31

trochanteric pressure sores.

31 flaps successful. Average hospitalization

of 14 days (range 5 – 21 days) . Average

follow-up time 13 months

The flap is reliable and

easily designed.

Formation of dead

space and the cone-

shaped dog-ear

deformity due to

rotation is prevented.

Better esthetic results

are achieved.

Suture separation is

prevented via a

tension-free closure.

The de-epithelialized

part produces tight

attachment of the flap

to the recipient bed.

No muscle tissue is

included so the flap is

more resistant to

pressure.

Ay A, Aytekin O,

Aytekin A.

Interdigitating

fasciocutaneous

gluteal V-Y

advancement flaps for

reconstruction of

sacral defects. Ann

Plast Surg.

2003;50(6):636-8.

14 patients with

sacral pressure sores

and 1 patient with a

chronic pilonidal

sinus.

4 female and 11

males, mean 38.2

years (range 16-57).

Mean diameter of

sacral defect 13.6

cm. (range 10 cm –

17 cm).

Mean follow-up was

6 months (range 6-16

months).

Case Reports The V-Y advancement

procedure was used. Flap

incision down to the facia of

the gluteal maximus but

muscle is preserved. Drains

inserted, removed day 3,

sutures removed after 14 to

18 days postoperatively.

Healed ulcer and flap All flaps survived and healed without major

problems. One flap with superficial necrosis

at distal end of one arm of the flap. Healed

without secondary operation.

Digitizing the middle V-

Y vascio-cutaneous

flap avoids a straight

line closure and the

resulting functional

defect.

Baran CN, Celebioğlu

S, Civelek B, Sensöz O.

Tangentially split

gluteus maximus

myocutaneous island

flap based on

perforator arteries for

From 1995 to 1997,

30 patients (18

female and 12 male)

were included. 17

were ambulatory, 13

paraplegic and

bedridden. 36 flaps

Case Reports Elliptical gluteal maximus

flaps taken from sites near

the ulcer were used in all

patients. Muscle mass of ½

the depth of total gluteal

maximus muscle taken from

flap site.

Healed pressure ulcers. Three patients lost to follow-up. Of follow-

up patients all flaps healed. One required a

second reconstruction due to necrosis, one

with wound infection closed the site by

secondary healing.

No mention of post-

operative treatments

used


142

Reference


Length of Follow-up

Results Limitations

the reconstruction of

pressure sores. Plast

Reconstr Surg.

1999;103(7):2071.

were surgically

placed. Some

patients had more

than one ulcer.

20 sacral, 8

trochanter, and 8

ischial ulcers were

included.

18 month

postoperative follow-

up period with

regular checkups.

Borman H, Maral T.

The gluteal

fasciocutaneous

rotation-advancement

flap with V-Y closure in

the management of

sacral pressure sores.


2002;109(7):2325-9.

Between 1998 and

2001, 15 patients (11

male, 4 female) with

decubitus ulcers

surgically repaired

using gluteal fascio-

cutaneous rotation-

advancement flaps

with V-Y closure.

Mean age 48.2 years

(range 34-84).

All ulcers stage IV.

Between 4 to 18 cm.

(mean 9.3).

Case Reports Debride ulcer and underlying

bone as necessary. Using the

V-Y advancement flap ulcers

were surgically repaired, with

suctions drains used in all 15

surgical sites.

All patients healed with need

for further surgery

1.5 to 35 month follow-ups all flaps healed

and survived.

The technique is

simple, can be

performed quickly, has

minimal associated

morbidity, and yields a

good outcome.

Buluc L, Tosun B, Sen

C, Sarlak AY. A

modified technique for

transposition of the

reverse sural artery

flap. Plast Reconstr

Surg.

2006;117(7):2488-92.

10 patients with

assorted tissue

defects of the ankle

of foot region,

treated with 11

reverse sural artery

flaps.

Etiology factors were

pressure sores (4)

postsurgical

debridement (3)

trauma (3).

All procedures

performed by same

surgeon.

Mean age was 44

years (range 10 –

75).

Case Reports The reverse flaps were taken

above the sore, and

positioned on the ulcer after

transport through a

subcutaneous tunnel.

Healed ulcers. 8 flaps survived completely. Partial skin loss

and distal tip necrosis in the two diabetic

patients.

The reverse sural

artery flap is a reliable

alternative for small to

moderate size defects

and can be used with

modifications of the

original technique.


143

Reference


Length of Follow-up

Results Limitations

Chen TH. Bilateral

gluteus maximus V-Y

advancement

musculo-cutaneous

flaps for the coverage

of large sacral pressure

sores: revisit and

refinement. Ann Plast

Surg. 1995;35(5):492-

7.

63 consecutive

patients undergoing

bilateral gluteus

maximus V-Y

advancement

musculo-cutaneous

flaps with

refinements.

Case Reports 63 patients undergoing the

V-Y refinement surgery.

Follow-up period of 28

months (range 6-62 months).

Average hospital stay was

38.5 days.

Repair of ulcer and healing. 93% or 59 patients achieved complete

healing. 4 patients had recurrent sacral

sores.

4 patients (6%) had dehiscence requiring

skin grafting, 9 patients (16%) had wound

infections without loss of flap.

No significant

functional impairment

related to the flap

procedure was noted.

Coşkunfirat OK,

Ozgentaş HE. Gluteal

perforator flaps for

coverage of pressure

sores at various

locations. Plast

Reconstr Surg.

2004;113(7):2012.

32 patients, 16 men

and 16 women,

operated on

between Nov. 1998

and June 2002 on

pressure sores at

various sites. Mean

age of 53.1 years

(range 5 to 87 years).

All grade III or IV per

Shea classification.

22 sacral, 7 ischial, 6

trochanter. 18

patients plegic, and 5

bedridden.

Case Reports 32 patients were followed for

a mean of 13.6 months

(range 0 to 38 months). One

patient died from pulmonary

emboli, two from MI’s .

Healing of all flaps One flap totally necrosed (2.9%) performed

on a patient right after a CABG on

anticoagulants.

One recurrence (2.9%) after 5 months

repaired and healed post second surgery.

All flaps healed except one, even in diabetic

and atherosclerotic patients.

No inclusion or

exclusion criteria

presented.

Freedom in flap design

and low donor-site

morbidity make the

gluteal perforator flaps

and excellent choice

for pressure sore

coverage.

Foster RD, Anthony JP,

Mathes SJ, Hoffman

WY. Ischial pressure

sore coverage: a

rationale for flap

selection. Br J Plast

Surg. 1997;50(5):374-

9.

114 consecutive

patients undergoing

flap coverage of 139

ischial pressure sores

between 1979 and

1995

Case Reports Detailed information

collected from 112 flaps in 87

unselected patients from the

initial 114 patients. 64 men

and 23 women, mean age

49years (range 16 – 90).

89% were paraplegic, 4%

quadriplegic, and 7%

ambulatory.

Follow-up ranged from one

month to 9 years, average

10.7 months.

Flap success and primary

healing were defined as a

healed wound within one

month postoperatively.

89% healed primarily.

For flap with the greatest significant

experience, (greater than 10 cases), the

inferior gluteus maximus island flap and the

inferior gluteal thigh flap had the highest

success rates, 94% and 93% respectively.

Average hospital stay was 21 days, average

time to heal was 38 days. Earliest time

healing could occur, as described in study,

was 28 days, at time of suture removal.

When flaps failed to

heal it was usually the

result of partial flap

necrosis (n=10)

inadequate

debridement and

subsequent failure to

control infection (n=5)

or wound dehiscence

(n=5).

Gusenoff JA, Redett RJ,

Nahabedian MY.

Outcomes for surgical

coverage of pressure

sores in

nonambulatory,

nonparaplegic, elderly

patients. Ann Plast

22 consecutive

elderly patients with

27 pressure sores

operated on

between 1995 and

1998 by the same

surgeon.

Case Reports Patients categorized into

three groups based on ulcer

location: sacrum, trochanter,

or ischium.

19 sacral ulcers, 7 trochanter

ulcers, and 1 ischial ulcer.

Four patients had both sacral

and trochanter ulcers and

Over all there were 11

complications of the 22 patients

(50%). Well healed flap present

in 19 of the 27 ulcers (70%) at

the average follow-up of 6

months.

Of the 22 patients, 4 were lost to follow-up.

9 of the 19 (47%) had initial well healed

ulcers at 6 months, 3 patients, (16%) healed

by secondary intention, two had poor

wound healing (11%) and 4 patients (21%)

were lost to follow-up. One patient had a

recurrence 6 months after initial repair.

Trochanter group had 7 patients, three men

Patient selection is

critical to the outcome

of surgical treatment

for pressure sores.

Comprehensive

postoperative

rehabilitation is

essential.


144

Reference


Length of Follow-up

Results Limitations

Surg. 2002;48(6):633-

40.

Sacral group of 11

men and 8 women,

mean age 61. 14

were non-

ambulatory, 2 very

poor ambulatory,

and 3 ambulatory.

16 stage IV ulcers

and 3 stage III.

Of the 22 patients, 4

were lost to follow-

up. Average follow-

up of the remaining

18 was 6 months

(range 3 months to 2

years).

one had both trochanter and

ischial, making a total of 27

ulcers in 22 patients.

Mean age was 59 years

(range, 50-82).

Inclusion criteria were

motivation, clean wounds

with signs of healing, normal

albumin and nitrogen

balance, and control of

spasticity if present.

Exclusion criteria included

flexion contractures near the

area of reconstruction,

vascular disease

compromising the flaps or

wound healing, and poor

nutritional status.

and four women, mean age 66 years, all no-

ambulatory with grade IV ulcers.

No complications, 100% excellent outcomes

at 6 months follow-up.

Ischial patient, a 50 year old paraplegic, had

a grade IV sacral and a grade IV ischial ulcer.

Postoperative dehiscence with revision.

Final outcome excellent healing.

Flap selection must

not only cover the

wound but leave

options for recurrent

ulcers and other flap

options.

It is imperative

postoperative care be

utilized to prevent

recurrence.

Homma K, Murakami

G, Fujioka H, Fujita T,

Imai A, Ezoe K.

Treatment of ischial

pressure ulcers with a

posteromedial thigh

fasciocutaneous flap.


2001;108(7):1990.

Case Reports 11 pressure ulcers in 10

paraplegic patients

surgically repaired

Surgical repair of ulcers using

a Posteromedial Thigh

Fasciocutaneous Flap.

Surgeries performed

between May 1986 and

January 1999. Seven male

and three females age range

30 to 74 years (average 52.5).

Postoperative follow-up

period ranged from 16

months to 14 years, (average,

77 months).

All flaps survived and healed. After average follow-up time of 77 months,

no recurrence in 7 of the 11 closures.

Pressure sore free period of 46 months in

the recurrent group, and 68 months in the

non-recurrent group.

Overall pressure sore free period is 5 years.

Of the 11 flaps, two

experienced viability

problems. Losses from

failure to properly

include the perforator.

Conclusion that width

of the flap should be

greater than 5 cm.

Ichioka S, Okabe K,

Tsuji S, Ohura N,

Nakatsuka T. Distal

perforator-based

fasciocutaneous V-Y

flap for treatment of

sacral pressure ulcers.


2004;114(4):906-9.-5.

Since 1993,

management of 32

patients (21 men and

10 women). Mean

age 62.3 years (range

20-88 years). All

stage IV ulcers, mean

defect size of 10.8

cm, (range 8-16 cm).

All reconstructed

with a unilateral flap.

Average follow-up

period was 54.8

months (range 3-124

months).

Case Reports This technique used in

defects greater than 8 cm

only as those could be

covered with standard V-Y

flaps without distal muscular

incisions.

Covered ulcers and healed flaps

with minimal functional deficit.

Overall 93.5% of the flaps healed primarily.

Two had early postop dehiscence with one

requiring secondary suturing 18 days after

first operation. These wounds healed

uneventfully in the postop period.

This variation of the

unilateral flap is very

useful in the coverage

of large ulcers.


145

Reference


Length of Follow-up

Results Limitations

Ichioka S, Okabe K,

Tsuji S, Ohura N,

Nakatsuka T. Triple

coverage of ischial

ulcers with

adipofascial turnover

and fasciocutaneous

flaps. Plast Reconstr

Surg. 2004;114(4):901-

5.

17 male and 5

female patients were

treated. Mean age

46.3 years (range 27-

84 years). 17

patients were

paraplegic, one was

quadriplegic, four

with cerebral

infarction, spina

bifida, and multiple

sclerosis.

All patients had stage

IV ulcers.

Case Reports After debridement of the

area, the skin overlying each

flap is undermined leaving an

adequate thickness of

subcutaneous tissue beneath.

The adiposfascial flaps are

dissected from the

underlying muscle then

turned over in a manner so as

to overlap each other to

cover the exposed bone. A

local fasciocutaneous flap is

then applied to the raw

surface of the turned over

flaps in a manner to cover

the area.

Healed flaps Overall 86.4% of the flaps (19 out of 22)

healed primarily.

Average follow-up period was 77 months

(range 1 – 159 months)

Three patients had complications including

wound infection, partial fat necrosis, and

seroma. These healed conservatively within

a 5 week period postoperatively.

One patient with MS had superficial

epidermolysis at the second postoperative

month that improved conservatively.

One patient with cerebral infarct developed

a recurrent subcutaneous pocket 2 months

post-surgery. Negative pressure therapy for

2 weeks conservatively obliterated the

subcutaneous cavity.

Triple coverage with

the combination of

double adipofascial

turnover flaps and a

local fasciocutaneous

flap allows for an

easily performed and

minimally invasive

procedure,

preservation of future

flap options, and a

soft-tissue supply

sufficient for covering

bony prominence and

filling dead space.

This technique

provides successful

soft-tissue

reconstruction for

minor to moderate-

sized ischial pressure

ulcers.

Ishida LH, Munhoz AM,

Montag E, Alves HRN,

Saito FL, Nakamoto

HA, et al. Tensor

fasciae latae

perforator flap:

minimizing donor-site

morbidity in the

treatment of

trochanteric pressure

sores. Plast Reconstr

Surg.

2005;116(5):1346-52.

24 fresh cadavers

were dissected.

21 patients

underwent a clinical

study between

January 1999 and

November 2003

where 22 tensor

fasciae latae

perforator flaps were

performed, one

bilaterally.

Mean age 40 (range

19-70 years).

19 patients

paraplegic and 2

paraparetic.

Mean ulcer size was

6.65 X 6.54 cm.

Mean flap size was

7.5 X 13.22 cm.

Ulcer size ranged

from 4 X 5 cm to 5 X

Case Reports The cadaver dissections were

used to mark parameters for

the location of perforators

larger than 1 mm. in an area

marked by anatomical

locators defined as A.)

Anteriorsuperior iliac spine,

B.) Lateral margin of the

Patella, C.) pubis, and D.) the

trochanter prominence.

Two axis were designated,

axis X , running between

points A and B and axis Y

delineating points C and D. A

10 cm arc around point D was

lifted and the perforators

marked and tabled

coordinates were then used

to find same in the live

clinical patients.

Coverage and healing of the

flaps was observed.

Two flaps experienced donor site wound

dehiscence with subsequent would dressing

changes till healed

Average drainage time was three days.

No other complications were reported.

No statistics were reported.

Main disadvantage of

this flap reported to be

the fragility of its

pedicle demanding

more attention on the

part of the surgeon

when positioning the

flap to prevent pedicle

tension.

This flap an alternative

to myocutaneous flaps

as it preserves local

musculature without

functional sequelae in

ambulatory patients,

and preserves

musculature in event

of recurrence, as is

usually seen in

paralytic patients.


146

Reference


Length of Follow-up

Results Limitations

10 cm.

Of the 22 flaps, 17

had 1 or 2

perforators, three

had 3 perforators

and the largest flap

had 21 perforators

intact for a mean of

1.81.

Jósvay J, Sashegyi M,

Kelemen P, Donáth A.

Clinical experience

with the hatchet-

shaped gluteus

maximus musculo-

cutaneous flap. Ann

Plast Surg.

2005;55(2):179-82.

Between January

1998 and December

2003 this method

was used on 54

patients and 71 total

flaps.

Age ranged from 10

weeks to 72 years.

Follow-up period was

10 to 64 months.

Case Reports This procedure was used on

31 patients with sacral

decubitus ulcers, ischial

ulcers on 12 patients,

trochanter ulcer on one

patient. Later in the study

used on nondecubitus

defects such as

myelomeningocele (4 pts.)

Crohn disease (3 pts.)

pilonidal sinus (2 pts.) and

traumatic defect on one pts.

Despite the few complications,

all but two flaps healed and

ulcers covered successfully.

Two relapsed, were treated at

another institution, and were

not included in follow-up

Seroma (4,) hematoma (2), Postoperative

bleeding (1), and partial flap necrosis (1)

healed following emptying and repeated

surgery.

Recurrent ulcer was seen in 2 cases.

Postoperative bleed was surgically repaired

day 7, and subsequently healed.

Seroma and hematoma all cleaned and

patent healed.

Crohn's disease patient had flap edge

necrosis and wound dehiscence, later

surgically repaired and healed.

One sacral and one ischial pressure ulcer

relapsed and these were re-operated on at

another institution.

Advantages are fewer

incisions needed,

shorter operating

time, and smaller

blood loss as

compared with

methods known so far.

The new incision

direction improves the

safety of the

circulation in the flap,

the closure of the

donor site is simpler,

and no contour

difference remains in

the surgical area.

Jósvay J, Donáth A.

Modified hamstring

musculocutaneous flap

for the coverage of

ischial pressure sores.


1999;103(6):1715-8.

Report of a V-Y

advancement of the

hamstring muscles

and overlying skin on

one 18 year old

patient born with

spina bifida and

paraplegic since

birth.

Case Report

Not an actual study.

Healed and covered ulcer

Complete healing and non-recurrence of

the ischial sore on this patient.

This type of procedure was performed on 10

other patients with 11 (one bilateral) for

similar results. Healing was undisturbed in

all patients without recurrence, even after

loading.

Most recent of these 11 surgeries was 6

months ago at time of report.

Koladi J, Gang RK,

Hamza AA, George A,

Bang RL, Rajacic N.

Versatility of the

distally based

superficial sural flap

for reconstruction of

From June 1998 to

June 2000 20

children between

ages 1 and 12 (mean

6 years) underwent a

distally based


Case Reports Two cases involved open

joint injuries, six involved

dorsum of the foot with

exposed tendons, three

occurred in the weight

bearing heel region, and two

had definite epiphyseal

Healed defect with functionality One wound with infection, one with partial

flap necrosis.

Distally based


has advantages of

being easy to perform,

short operating time,

minimal donor site

morbidity, and


147

Reference


Length of Follow-up

Results Limitations

lower leg and foot in

children. J Pediatr

Orthop.

2003;23(2):194-8.

not all subjects had

PrU

for coverage of

defects at the lower

leg and foot.

Mean follow-up was

2 years

15 patients had

trauma to the lower

leg, 3 had post burn

contracture, 2 had

pressure sores.

Flap size from 3 X 4

to 8 X 10 cm.

injuries.

Fasciocutaneous flap was

used in 14 cases and a fascial

flap covered with skin graft in

6 cases.

Treatment of acute trauma

included radical wound

debridement followed by a

distally based superficial sural

flap. In 8 cases the flap was

performed immediately after

debridement, in 12 others

defects were covered within

the first week of injury.

Three had simultaneous

tendon reconstruction and 7

patients with underlying

fractures required bone

fixation.

preservation of major

arteries of the leg.

Ohjimi H, Ogata K,

Setsu Y, Haraga I.

Modification of the

gluteus maximus V-Y

advancement flap for

sacral ulcers: the

gluteal

fasciocutaneous flap

method. Plast

Reconstr Surg.

1996;98(7):1247-52.

Not all subjects had

PrU

24 patients with

sacral ulcers treated

with this variation of

the V-Y flap.

19 had sacral

pressure ulcers, 2

had radiation ulcer.

18 of the group were

ambulatory.

Age range from 20 to

91 years.

Mean defect size was

9 cm (range 5 to 15

cm in transverse

diameter)

Follow-up mean was

24.3 months (range 2

to 60 months).

Average blood loss

was 250 ml during

surgery.

Case Reports Defects with average size of

6.7 X 7.6 cm were

reconstructed with unilateral

gluteal fasciocutaneous flaps

Defects of average size of

11.2 X 11.1 cm were

reconstructed with a bilateral

gluteal fasciocutaneous flaps.

Healed defect without

functional deficit

No flap necrosis and no functional deficit in

any of the ambulatory patients followed up

over one year.

Recurrent wound infections in three

patients after surgery. All healed with

secondary treatment.

Two patients died or original condition.

The gluteal


method for sacral

defects decreases

blood loss and

shortens the operating

time during surgery

compare with the

conventional gluteus

maximus musculo-

cutaneous flap

methods.

Rajacic N, Gang RK,

Dashti H, Behbehani A.

Treatment of ischial

pressure sores with an

inferior gluteus

37 paraplegic

patients with 31

ischial pressure sores

of moderate size.

31 consecutive

All treated by using an

island gluteus maximus

musculocutaneous flap

of the most inferior part

of the muscle based on

Description of experience Complete healing of both

surgical and donor sites.

One patient died of sepsis not related to the

flap

All patients treated achieved complete

healing of the surgery site and donor sites at

time of hospital discharge.

Experience with this

group suggests that

the inferior gluteus

maximus island flap is

a very useful method


148

Reference


Length of Follow-up

Results Limitations

maximus

musculocutaneous

island flap: an analysis

of 31 flaps. Br J Plast

Surg. 1994;47(6):431-

4.

ischial wounds.

20 males and 7

females

Age mean of 35 years

(range 15 to 47

years).

All patients suffered

from post-traumatic

paraplegia, 4 of

which had

undergone earlier

attempts at wound

closure.

branches of the inferior

gluteal artery.

Postoperatively all

patients were entirely

non-weight bearing for

2 weeks with air-

flotation beds, then

transferred to regular

bed for another 3

weeks and kept off the

operation site.

26 patients followed for

an average of 12

months (range 6 – 32

months).

Mean hospital period

after closure was 40

days.

2 had complications related to inadequate

excision of the sore with minor infection,

healed spontaneously.

6 cases had partial dehiscence of the donor

site. Three healed spontaneously, in 2 a

secondary revision of the wound was done

to accelerate healing, recurrence of

bedsores occurred in three patients

between 6 and 13 months after surgery.

These required another surgical flap

of providing soft tissue

coverage for minor to

moderate-sized ischial

pressure sores.

The number of donor

site complications

indicates the need for

tension-free closure

with better

obliteration of the

secondary “dead”

space and proper

drainage.

Rubayi S, Doyle BS.

The gluteus maximus

muscle-splitting

myocutaneous flap for

treatment of sacral

and coccygeal pressure

ulcers. Plast Reconstr

Surg. 1995;96(6):1366-

71.

28 patients with

stage IV sacral or

coccygeal pressure

ulcers.

Mean defect size 4 X

4 cm.

Mean follow-up of 15

months (range 2 to

40 months).

20 males and 8

females age range 14

to 78 years (mean

age 36 years).

Average time from

onset of ulcer and

surgery was 6

months.

21 sacral ulcers, 7

coccygeal ulcers.

Average size of ulcer

at surgery was 4 X 4

cm (range 2 x 2 to 10

X 10cm).

All patients followed

in hospital for

minimum of 8 weeks.

Case Reports The gluteus maximus muscle

is split in this study

Healing and closure of wounds 27 patients achieved complete healing at

final follow-up.

One patient died 12 months postoperatively

of medical causes.

Complications occurred in 7 patients. 4

patients had either breakdown of the flap or

superficial wound dehiscence within the first

6 weeks. One had a revision of the flap, one

had a split thickness skin graft to close the

defect, and 2 patients wounds healed by

secondary intention.

3 patients had breakdown of the flap site

occurring 6, 11, and 16 months

postoperatively. One had a flap revision,

one healed secondarily with wound care,

and one refused further surgery and did not

follow-up after.

Advantages of the

gluteal maximus

muscle-splitting

myocutaneous flap

include reduced blood

loss, preservation of

most of the gluteus

maximus for future

use, and retained

function of the gluteus

maximus for stair

climbing and single-

limb support in the

ambulatory patient.


149

Reference


Length of Follow-up

Results Limitations

Scheufler O, Farhadi J,

Kovach SJ, Kukies S,

Pierer G, Levin LS, et

al. Anatomical basis

and clinical application

of the infragluteal

perforator flap. Plast

Reconstr Surg.

2006;118(6):1389-400.

13 patients, 11 men

and 2 women, mean

age 47 (range 33 to

68 years).

9 ischial ulcers, 3

sacral, 1

trochanteric.

Mean ulcer size at

time of surgery 44.6

cm X 14.2 cm (range

25 to 64 cm).

All ulcers grade IV of

V.

Divided into two

groups, Group A

perforator-based flap

reconstruction and

Group B perforator

flap reconstruction.

Mean operating time

Group A was 94

minutes (range 80 to

120 minutes).

Mean operating time

Group B 137 minutes

(range 90 to 200

minutes).

Donor sites all closed

primarily.

Case Reports This flap is designed to

minimize donor-site

morbidity by sparing the

gluteal muscle and primary

closure of the donor site,

leaving a scar that avoids

maximal pressure zones over

bony prominences. The

surgeries in these reports

were done in such a manner.

Coverage of wound and total

healing.

12 of 13 flaps healed uneventfully.

One flap from Group B necrosed totally.

This elderly patient had multiple scars

adjacent to the flap donor site following

several operations for ischial pressure sore

recurrence.

In all cadaver and

clinical dissections one

or two cutaneous

branches of the

descending branch of

the inferior gluteal

artery and one or two

nerves were found at

the lower border of

the gluteus maximus

muscle supplying the

infragluteal perforator

flap. These provided

flaps with more

mobility compared

with perforator based

flaps and spared the

descending branch of

the inferior gluteal

artery for future flaps

if necessary.

Schmidt AB, Fromberg

G, Ruidisch MH.

Applications of the

pedicled vastus

lateralis flap for

patients with

complicated pressure

sores. Spinal Cord.

1997;35(7):437-42.

From 1988 to 1995

38 vastus lateral

flaps were

performed.

Average age 43

(range 17 to 72

years).

Follow-up mean 14


months).

Case Reports Surgeries done for coverage

of complicated severe

wounds. The vastus lateralis

flap is classically a salvage

procedure to deal with a

second, third, or later

recurrence of a pressure sore

and all conventional flaps are

no longer possible. This

study demonstrated various

possible uses for this flap and

its versatility for complicated

wound coverage.

Covered wound and healed

sites

In 24 patients healing was uneventful.

Impaired healing at the recipient site

required operative revision. Donor site

complications requiring split skin grafting

occurred in 4 patients. Multiple

complications occurred in three patients.

Complications included flap necrosis (1),

partial flap necrosis (1), delayed healing

recipient site (7), delayed healing donor site

(4), recurrence of pressure sore (1),

recurrence of osteitis (2), pain of donor site

in rehabilitation (1).

One electrical burn patient died one week

The

musculocutaneous

vastus lateralis flap is

important in the

treatment of

complicated recurrent

pressure sores and

defects after vascular

occlusion at iliac level.

The disadvantages of

some blood loss and

slightly difficult

dissection are

outweighed by the

advantages of a big arc


150

Reference


Length of Follow-up

Results Limitations

postoperatively from multisystem failure. of rotation and the

fact that the flap is still

available despite

multiple previous

surgeries.

Tavakoli K, Rutkowski

S, Cope C, Hassall M,

Barnett R, Richards M,

et al. Recurrence rates

of ischial sores in para-

and tetraplegics

treated with hamstring

flaps: an 8-year study.

Br J Plast Surg.

1999;52(6):476-9.

Follow-up or 27

patients who

underwent

musculocutaneous

flap closure of their

ischial pressure

sores.

37 ulcers treated

between 1988 and

1993 using a V-Y

advancement

hamstring

musculocutaneous

island flap.

Initial follow-up in

1993, mean period

20 months.

Second follow-up

1997 mean period 62

months (range 18 to

90 months)

Mean age second

follow-up of 43.7

(range 11-77 years).

13 males 10 females

23 patients followed

second round, 4 lost

from initial follow-

up.

Follow-up or prior

surgeries.

Follow-up review of data Healed ulcers without

recurrence.

At initial follow-up in 1993, despite 33% of

patients having had recurrent ulcers and

14.8% having undergone re-advancements,

only 14 % of patients had non-healing

ulcers.

Second follow-up in 1997, 19 live patients

remained, with the deceased 4 patients flap

condition known prior to death and data

included in this follow-up.

7 flaps underwent a re-advancement of

their flap with one requiring a second re-

advancement. Period of recurrence mean

of 22 months (range 0.5 – 70 months).

Mean age of patients with recurrence was

37.8 with 53.8% being male and 40% being

female.

Recurrence rates of ulcers were 41.4% and

47.8% respectively. 58.6% of flaps therefore

had never broken down since initial

intervention. In 1997, 17 out of the 19 living

patients (89.5%) showed no evidence of

ulceration in the region of their flaps

The V-Y hamstring flap

is justified and the

recurrence rates are

comparable with data

in the literature.

Meticulous education

and prompt follow-up

that ensures surgical

reconstruction

remains the mainstay

of treatment in this

group of patients.

Tunçbilek G, Nasir S,

Ozkan O, Kayikçioğlu

A, Mavili E. Partially

de-epithelialized and

buried V-Y


reconstruction of

sacrococcygeal and

ischial defects. Scand J

Plast Reconstr Surg

16 patients operated

on using this

technique.

Age range 23-67

years.

Defect size range 6 –

16 cm in diameter.

No previous

treatment of soft

tissue defects.

Case Reports this study, the V-Y

advancement flap was

modified by de-epithelializing

the medial part of the flap

and burying them under the

opposing edge of the wound

or the flap.

All flaps healed well with no

partial of complete loss of the

flap.

All pressure ulcers recovered completely

after the follow-up periods. Complications

developed in 3 patients. One severe

uncontrolled diabetic on steroids for

multiple sclerosis had a severe wound

infection and an abscess. The wound was

resutured, and healed without flap loss.

Another diabetic developed a seroma after

mobilizing too soon. Aspiration and

pressure dressings resulted in wound

Main advantage is the

use of healthy tissues

to obliterate the dead

spaces under the

edges of the wound or

the opposing flap. The

additional layer of

tissue between the

bone and the

superficial tissues


151

Reference


Length of Follow-up

Results Limitations

Hand Surg. 2004;

38(2):94-9.

Follow-up mean 10.5


months).

Operation time mean

150 minutes (range

90-200 minutes).

Blood loss mean 300

ml (range 150 – 500

ml).

11 patient defects

closed using a

unilateral flap, 5

patients closed with

a bilateral flap.

12 of 14 with

pressure ulcers had

sacrococcygeal, one

had sacrococcygeal

and an ischial, and

one had an ischial

ulcer.

Nine were

ambulatory, and 7

were paraplegic or

bedridden.

healing without tissue loss.

One developed a minor superficial skin

slough at the medial suture line.

provides an extra

cushion of soft tissue

putting the suture line

directly over the bony

prominences.

Ulusoy MG, Akan IM,

Sensöz O, Ozdemir R.

Bilateral, extended V-Y

advancement flap. Ann

Plast Surg. 2001;

46(1):5-8.

10 patients with

large sacral and

trochanteric pressure

Follow-up range 2-10

months.

Defect range 10 – 20

cm.

Age range 15 years –

58 years.

Case Reports The usual V-Y flap design is

to have the flaps directly

across from each other either

side of the wound. In this

modification, the flaps were

offset, so one wing was even

with the defect, and the

other wing of that same flap

was farther away from the

edge of the wound, One flap

wing would look like a one

dimensional arm of the Y and

the other would be a very

wide arm of the Y. The two

opposing wide wings of each

flap were then pulled into the

center of the wound and

positioned side by side. The

resulting scar was then more

like an S than a typical V or

Closure of wound and healing No complications. And complete healing of

the flaps with no recurrence during the

follow-up period.

Since most of the

tension on a V-Y flap

closure is where the

two flaps meet in the

center, by changing

the typical closure

suture line in the

center the tension is

redistributed over a

larger area with less in

one point than in some

earlier V-Y flap closure

lines.

This zig-zag suture line

in the center of the

closure works very

well for large wound

closures.


152

Reference


Length of Follow-up

Results Limitations

straight line.

Wong C-H, Tan B-K,

Song C. The

perforator-sparing

buttock rotation flap

for coverage of

pressure sores. Plast

Reconstr Surg.

2007;119(4):1259-66.

Seven patients with

mean age of 52

(range 33 to 62

years) underwent

reconstruction with

this perforator –

sparing rotation flap

technique.

Mean follow-up was

30 months (range 9 –

51 months).

4 patients needed

muscle to fill the

dead space, and the

muscle flap was

performed

independently of the

skin flap.

Case Reports Coverage of wound and healing

of flap without necrosis

All flaps healed without necrosis or

complication. Early breakdown rate was 0 %

and no ulcer recurrence occurred over the

follow-up period.

Advantages include:

preservation and

inclusion of the

dominant perforator

augments the blood

supply of the


and allows the same

amount of

mobilization as the

classic design, The

improved vascularity

renders the flap more

robust and better able

to withstand pressure-

induced ischemia, and

in the event of

recurrence, re-rotation

is possible.

Yamamoto Y,

Tsutsumida A,

Murazumi M, Sugihara

T. Long-term outcome

of pressure sores

treated with flap

coverage. Plast

Reconstr Surg.

1997;100(5):1212-7.

53 paraplegic

patients with 45

ischial and 24 sacral

sores between 1990

and 1995 were

treated with flap

coverage.

48 males and 5

females ages ranging

from 17 – 75 years

(mean 50).

Two types of flaps

were used:

Type I

:Fasciocutaneous flap

and Type 2.)

myocutaneous flap.

Average follow-up

was 3 years and 6

months (range 4

months to 5 years

and 4 months),

Case Reports.

A review of long term

recurrence after flap surgery

for coverage of defects of

ischial or sacral pressure

sores.

No recurrence, or very low

incidence of recurrence over the

long term follow-up.

18 of the 45 ischial defects covered with

Type I flaps. 27 with a Type II flap. Total # of

transferred flaps was 48 in 45 sores.

23 of the 24 sacral defects were covered

with a Type I flap. Total # of transferred

flaps was 24 of 24 sores.

The Percent pressure sores free survival

(%PSFS) was calculated by means of the

Kaplan-Meier method and the log rank test.

Because a few patients had multiple sores,

the dada are not independent.

Recurrence was noted in 22 or 45 ischial

sores (48.9%). 27.8 % were from a Type I

flap and a 63% recurrence in the Type II flap.

Recurrence was noted in 5 of 27 sacral sores

(20.8%) with 17.4% being from a Type I flap.

At 36 months the %PSFS was 70% in sacral

sores compared to 50% in ischial sores

Long term follow-up is

essential in order to

lean which flaps are

better suited for

differing types of

reconstructive

surgeries.


153


Length of Follow-up

Results Limitations

Akyürek M, Safak T,

Sönmez E, Ozkan O,

Keçik A. A new flap

design: neural-island

flap. Plast Reconstr

Surg.

2004;114(6):1467-77.

92 Wistar rats were

used for three

experiments. 1)

Vascular anatomy of

the femoral

cutaneous nerve was

established. 2) The

role of the cutaneous

nerve in supporting

an acutely elevated

skin flap was

explored, and 3) the

role of the

preliminary surgical

delay procedure to

augment the survival

of the neural island

flap was

investigated.

Case Reports Each step was used to further

enhance the learning curve

for the next of the three

steps. After promising

experiments the Neural-

island flap was used on 4

human patients using a two-

week delay from flap harvest

to flap placement.

All four neural-island flaps

survived and healed

satisfactorily.

Skin flaps survive totally in groups where

the artery and vein were intact, whereas

mean survival rates for the neural island flap

and the neuro-cutaneous flap were 38.2 %

and 44.5% respectively. Results of part III of

the experiment demonstrated significantly

higher survival for the delayed neural island

flap 94.5% compared with the acutely

elevated neural island flap.

Authors conclude that

this report proves for the

first time that a robust

and reliable skin flap can

be created pedicled only

by the intrinsic

vasculature of a

cutaneous nerve, after a

proper surgical delay.

The neural island flap

offers two advantages: a

very narrow pedicle, and

a pedicle without any

restriction to a specific

pivot point.

Chen SH, Hentz VR,

Wei FC, Chen YR. Short

gracilis myocutaneous

flaps for vulvoperineal

and inguinal

reconstruction. Plast

Reconstr Surg.

1995;95(2):372-7.

16 short gracilis

myocutaneous flaps

and 1 short gracilis

muscular flap used to

reconstruct

vulvoperineal,

inguinal, perineal, an

ischial soft-tissue

defects from October

1990 to April 1993.

Case Reports 6 bilateral myocutaneous

flaps were used for

reconstruction post radical

vulvectomy. 5 were used for

reconstruction after

contracture scar removal.

Follow-up between 5 and 27

months

Repair and healing of the flaps. Immediate complications consisted of

necrosis of the distal third of the cutaneous

portion of the flap in 6 patients. 1 case of

superficial skin necrosis, and wound

infection in 7 patients. Muscular portion of

all flaps survived. A split-thickness skin graft

was used to cover the raw surface of the

remaining tissue.

Huang K-C, Peng K-T, Li

Y-Y, Tsai Y-H, Huang T-

J, Hsu RW-W. Modified

vastus lateralis flap in

treating a difficult hip

infection. J Trauma.

2005;59(3):665-

71.September;

59(3):665-71

Between January

2002 and June 2003

10 consecutive

patients, 5 male and

5 female, were

treated with the

modified vastus

lateralis muscle flap

transposition

immediately after

radical debridement

under the clinical

diagnosis of difficult

hip infection

Case Reports The 10 patients presented

with various stages of

previous treatments and

chronic hip infections. The

surgery relied heavily on

aggressive debridement of

the wound. Surgical times


minutes and blood loss

ranged from 250 – 2200 ml.

depending on the amount of

debridement needed prior to

flap transposition. Flaps

were sized and harvested as

Hip infections in all 10 patients

healed uneventfully.

No need for another soft tissue procedure

was indicated, C-reactive protein returned

to a stable and near-normal level within one

month.

All wounds healed uneventfully in an

average of 13 days (range 10-21 days).

Average hospital stay of 16 days (range 12-

24 days).

One developed a contralateral iliopsoas

abscess and a secondary septic hip 9 months

after the procedure.

Range of time for hip infection prior to

surgery was from 2 months to 15 months

The modified vastus

lateralis flap

transposition has two

primary advantages. 1)

the technique could be a

simple and reliable one-

stage procedure and 2)

the modified vastus

lateralis flap is extremely

versatile.


154


Length of Follow-up

Results Limitations

All patients had

previously

undergone an

average of 5

procedures, including

debridement,

specific antibiotic-

loaded

polymethylmethacryl

ate beads or interim

endoprosthesis, or

tensor fascia lata


transposition. These

procedures did not

control deep joint

infections or heal the

patients wounds.

Average follow-up

period was 17.4

months (range 9-27

months)

was best for each individual

case.

Huisinga RL, Houpt P,

Dijkstra R, Storm van

Leeuwen JB. The

distally based sural

artery flap. Ann Plast

Surg. 1998;41(1):58-

65.

14 patients with 15

defects of the lower

leg, malleolar, and

heel regions. Seven

patients were

vascularly

compromised

seriously.

Age range was 4 -81

years. Defect sites

were heel (6), lower

leg (2), lateral

malleolus (4), and

one calcaneus and

one dorsum of foot..

Defect size range was

3 X 3 cm to 10 X 14

cm.

Case Reports A teardrop shaped sural

artery flap was harvested for

each patient, size and

location of harvest depending

on location and size of

defect.

Twelve flaps survived

completely, two survived

partially, one flap failed.

No statistics were reported. Venous

congestion was reported in one patient,

successfully treated with leaches.

The failed flap turned out to have been

performed on a patient that 5 weeks prior

had patent peripheral arteries. The

circulation was not checked prior to surgery,

and circulation was non-existent at time of

surgery which resulted subsequently in

amputation for inoperable arterial disease.

This patient should not have been operated

on as it turns out.

One partial necrosis was in a diabetic patient

which was angiogramed with an open

peroneal artery.

Persistent infection compromised one flap.

None of the vascularly compromised

patients would have been candidates for

free flap surgery considering the failure rate

of 27%.

The sural artery flap has

the largest arc of rotation

of all flaps for this region.

It does not compromise a

major artery, is simple to

dissect, and has a low

donor morbidity.

Kim SE, Rhyou IH, Suh

BG, Chung KC. Use of

thoracodorsal artery

Between 2003 and

2004. 4 children (3

male, one female)

Case Reports The thoracodorsal perforator

flaps were taken on each

child under the left of right

Healed injury site, healed

harvest site, and full

functionality of sites.

Complete healing of defect, harvest site, and

full functionality of all areas of surgery.

Perforator free flap

(PFF)is not performed

with increasing frequency


155


Length of Follow-up

Results Limitations

perforator flap for soft

tissue reconstruction

in children. Ann Plast

Surg. 2006;56(4):451-

4.

with soft tissue

injuries were treated

with the use of a

thoracodorsal artery

flap graft.

Age range was 4 – 13

years.

Defect sites, one

right and one left

foot dorsum, one

right heel, and one

forearm.

axial. Acoustic doppler

sonography was used to

locate reliable perforators.

Harvested flap sutured in

place after anastomosis of

perforator artery to a viable

artery at transplant site.

in adults for soft tissue

reconstruction.

Many surgeons still

hesitate to perform PFF’s

in children due to

perceived high failure

rates related to the small

diameter of children’s

perforator vessels.

This flap is a viable

alternative to PFF’s for

use in children with soft

tissue defects requiring

surgery.

Knox K, Bitzos I,

Granick M, Datiashvili

R, Benevenia J,

Patterson F.

Immediate

reconstruction of

oncologic

hemipelvectomy

defects. Ann Plast

Surg. 2006;57(2):184-

9.

Between 1992 and

2002, 11 cases of

radical pelvic

resection and

immediate

reconstruction were

performed.

3 males and 8

females with a mean

age of 43.8 years.

Tumor types

consisted of

chondrosarcoma (6),

Paget osteosarcoma

(1), giant cell tumor

(1), malignant fibrous

histiocytoma (1),

squamous cell

carcinoma (1),

synovial sarcoma (1),

and metastatic

uterine carcinoma

(1).

Case Reports In each case immediate

reconstructive surgery was

necessary due to the size of

the extracted tumor.

Size and shape of the flap

varied with patient and

wound

In each patient, the wounds

healed sufficiently for hospital

release and ability to resume

daily living.

Endpoint goal of most

functionality post healing.

None reported Reconstructive surgery

following large pelvic

resections used as a

management tool to deal

with complications of a

primary closure, and

It can be implemented

for immediate closure

when primary closure is

not possible, when there

is significant dead space,

when vital pelvic

structure or organs are

exposed,

Primary reconstructive

option remains the

pedicled muscle flap.

Llanos S, Calderón W,

Searle S, Quintas M.

Improvement of the

bipedicled fascial flap

with a cutaneous V

and Y island for

Case series;

reproduction of

Hayashi, A, et al.,

Stepladder V-Y

advance-ment flap

for repair of postero-

4 cases A random fasciocutaneous

flap with bilateral

adipofascial pedicles using

the stepped incision

technique in combination

with the V-Y advancement

Researcher’s personal judgment

of improvements.

Researchers state that their results did “not

differ from the original work.”

Flap survival rates not

provided.


156


Length of Follow-up

Results Limitations

coverage of the heel.


2006;118(1):297-8.

plantar heel ulcers.

Br J Plast Surg 1997;

50:657.

principle.

Matsumura H, Makino

K, Watanabe K.

Reconstruction of the

sole and heel and

infancy in childhood

followed up for more

than 10 years. Ann

Plast Surg.

1995;34(5):488-92.

10 patients who

underwent

reconstruction of the

weight-bearing area

of the sole and heel.

Mean follow-up was

19 years 5 months

Mean age of 4 years

1 month (range 6

months to 9 years 3

months).

Case Reports Three criteria

1) Patients injured the weight

bearing area of the sole and

heal before age 10 and initial

reconstruction using tissue

other than the sole and heel

was performed.

2). Follow-up observation

was possible for more than

10 years

3). Follow-up observation

was possible until age 15 or

older.

Healing of initial wound or

defect and weight beating on

the graft as a child.

Secondary reconstruction of the weight-

bearing area was performed in 7 patients

because of hyperkeratosis and callus

formation with pain using non weight

bearing skin grafts.

Duration between initial and secondary

reconstruction mean was 16 years (range 11

years 1 month to 25 years 1 month) with

three requiring no further surgery.

Using non weight

bearing tissue for sole

and heel reconstruction is

a feasible option,

especially in children until

adolescence. If

secondary reconstruction

is then required, tissue

and skin from non-weight

bearing areas of the heel

and sole can them be

used once the foot has

reached mature size and

more such tissue is

available.

Milanov NO, Adamyan

RT. Functional results

of microsurgical

reconstruction of

plantar defects. Ann

Plast Surg.

1994;32(1):52-6.

Long term follow-up

results were

analyzed of 57

patients who

underwent

microsurgical

reconstruction of the

plantar surface. Age

range was 13 to 61

years. 77% were

working males.

Divided into two

groups,

36 patients with 37

free flaps included all

who did not develop

trophic ulcers on

their transferred

flaps.

21 patients (37%)

found to have

trophic ulcers.

Case Reports Roentgenographic

examination was performed

in two planes. Special

attention was directed to

osseous abnormalities such

as osteophytes and

osteomyelitic sequestrate in

the region of the free flap.

Biomechanical examination

of the foot. Gait and its time-

strength characteristics were

analyzed. Foot function was

examined, including the

weight bearing pattern on

rolling of the foot, the

vertical force component,

and the maximum pressure

distribution on standing and

walking.

Both studies were performed

before and after treatment.

Reduction of long term trophic

ulcers

Using the surgical techniques developed as

a result of the studies, secondary

development of trophic ulcers decreased

from 37% to 7 %.

Analysis demonstrated

the role of compensatory

mechanisms in the

formation of trophic

ulcers.

Proper surgical

management was seen to

assist in equalization of

pressure over the free

flap and minimize risk of

recurrence of the ulcer.

Oberlin C, Azoulay B,

Bhatia A. The

posterolateral

From 1988 to 1993

14 flaps were

performed in 13

Case Reports The flap taken along the

Achilles tendon region of the

leg with the deep fat intact, is

Complete coverage of wound

with healing of transplant and

donor site.

Flaps survived in all 13 patients.

One skin graft over donor site did not “take”

on one patient, allowed to heal secondarily.

The distally base

posterolateral malleolar

flap is technically easy to


157


Length of Follow-up

Results Limitations

malleolar flap of the

ankle: a distally based

sural neurocutaneous

flap--report of 14

cases. Plast Reconstr

Surg. 1995;96(2):400.

patients. 10 mend

and 3 women.

Mean age 54 years

(range 35 to 75

years).

10 patients had heel

injuries the

remaining patients

had skin defects over

the Achilles tendon,

the lateral malleolus,

and the medial

malleolus.

Eight cases of bone

loss, including four

cases of significant

defects in the

calcaneus.

5 patients with

absent lower limb

pulses, one case of

diabetes, one

unspecified

neurologic disorder,

and one paraplegic

Flap mean size was

13.5 cm long by 3 cm

wide (range 9 cm X

2.5 cm to 17 cm X 3

cm)

Donor defect closed

with skin grafts in 11

patients, primarily

closed in 2 patients.

One patient died 3

weeks after bilateral

heel coverage that

had fully healed.

then turned 180 degrees and

layed over the defect of the

heel and lower foot. The

donor site is either closed

primarily, or with split-skin

grafting.

A recurrent necrosis occurred in a previously

healed graft in a negligent patient in the

second month,

Remaining patients’ postoperative course

was uneventful.

perform, does not

require any fine vascular

dissection, morbidity of

the flap is negligible, with

only minor sensory loss.

Orgill DP, Pribaz JJ,

Morris DJ. Local

fasciocutaneous flaps

for olecranon

coverage. Ann Plast

Surg. 1994;32(1):27-

31.

11 fasciocutaneous

flaps were used in 10

patients.

Follow-up of 1 to 3

years.

A variety of flaps were

used to cover these

defects including, the

reverse lateral arm flap,

the posterior

interosseous flap, the

ulnar recurrent

Case Reports

Flap survival with wound closure

All flaps survived.

One patient had recurrent ulceration after

being healed for 6 months

One patient with a transient neuropraxia of

the posterior interosseous nerve that

resolved after 2 weeks.

None reported


158


Length of Follow-up

Results Limitations

fasciocutaneous flap,

and a proximally based

fasciocutaneous flap.

Rubin JA, Whetzel TP,

Stevenson TR. The

posterior thigh

fasciocutaneous flap:

vascular anatomy and

clinical application.


1995;95(7):1228-39.

24 patients

underwent posterior

thigh

fasciocutaneous flaps

between 1989 and

1992

Follow-up ranged

from 2 to 20 months.

Case Reports After study of 10 adult

cadavers within 48 hours of

death, and notation of all

perforator vessels supplying

blood to the thigh skin and

the use of dye to locate

vessels and the use of

dissection for photographic

study. this data was used to

help with the location and

lifting of the flaps for the

surgeries performed on the

24 patients in this report.

The posterior thigh fasciocutaneous flaps

were based entirely on fasciocutaneous

branches from the first and second profunda

femoris perforating arteries.

5 early post-operative complications. All

went on to satisfactorily healing with stable

wound coverage but one,

One patient developed partial wound

dehiscence related to refractory muscle

spasms resulting in delayed healing and

recurrent ulcer.

A posterior thigh

fascioucutaneous flap

based primarily on the

first and secondary

profunda femoris

perforating arteries

provides versatility and

reusability.

Safak T, Akyürek M.

The descending branch

of the superficial

circumflex artery

supplying

anteromedial thigh

skin. Plast Reconstr

Surg.

2004;114(5):1118-22.

10 patients with a

mean age of 45

(range 10 to 60

years) between Oct.

1999 and Jan. 2002

underwent defect

flap repairs.

6 male and 4 female.

6 free flaps and 4

local flaps were used

in the 10 patients.

Case Reports This flap is designed as

consisting of two paddles in

the groin and anteromedial

thigh regions. Upper paddle

designed traditionally based

on the superficial iliac

circumflex artery. The

second paddle is placed in

the anteromedial thigh

region

Local flaps were used for

reconstruction of scrotal

defect, trochanteric defect,

and lower abdominal skin

and fascia defects,

Free flaps used in

reconstruction for total facial

resurfacing, through and

through cheek defect, and

burn scar contractures and

traumatic defects of the

lower extremity.

Coverage of the defect and

healing of donor and flap site.

All 10 flaps survived completely.

Donor site complications included a seroma

in one case resolved by several syringe

aspirations and wound dehiscence in the

thigh region caused by infection. The latter

required split skin grafting secondarily.

The groin flap with

anteromedial thigh

extension offers these

advantages. 1). Very easy

and quick to elevate, 2).

Significantly increases

volume of tissue available

for reconstruction. 3).

Two skin paddles that are

independently mobile. 4.)

no need for positional

changes and a two-team

approach is possible. 5).

It can be raised as a

vertical skin island only.

Yildirim S, Taylan G,

Aköz T. Freestyle

perforator-based V-Y


reconstruction of soft

tissue defects at

various anatomic

26 perforator V-Y

advancement flaps in

24 patients

performed between

July 2004 and

November 2005.

14 female and 10

Case Reports Various V-Y advancement

flaps were elevated for

various defects around the

body. Flaps were of no

particular size of location, but

were prepared in proximity

to the defect as best to cover

Would coverage and flap

healing

One flap (3.8%) totally necrosed. It was

based on one perforator that was extremely

manipulated to cover the large defect and

was compressed from a hematoma found

under the flap during debridement.

One flap (3.8%) marginally necrosed and

was treated with daily dressings

This method is a useful

adjunct to reconstructive

surgical options and can

be used safely by plastic

surgeons at almost all

regions of the body and

without a need for a


159


Length of Follow-up

Results Limitations

regions. Ann Plast

Surg. 2007;58(5):501-

6.

males.

Mean age 48.3 years

(range 22 to 77

years).

Defect size range: 3 X

5 cm to 15 X 20 cm.

15 flaps (57.6%) were

elevated based on

two perforators, 7

flaps (26.9%) were

elevated based on

one perforator, and

the remaining 4

(16.8%) were

elevated based on

three perforators.

Mean follow-up as

14.2 months (range 9

to 21 months).

the wound.

successfully.

Other flaps survived totally (92.4%),

previously described

vascular anatomic

pattern


160

Table 13. Pressure Ulcer Management in Individuals Receiving Palliative Care Direct Evidence Reference Type of Study Sample Intervention(s) Outcome Measures &

Length of Follow-up

Results Limitations

Abbas SQ.

Diamorphine-Intrasite

dressings for painful

pressure ulcers. J Pain

Symptom Manage.

2004;28(6):532-4.

Also in Table 4 Pain

Retrospective study 17 patients (9 females,

8 males) with a

diagnosis of incurable

malignancy admitted

with Grade 2+ PrUs

over a period of 30

months. Mean age was

68 years (range 47-89).

Dressings were applied with

diamorphine 5-10mg &

Intrasite on a 4x4 dressing.

Dressing changed every 12-

24 hrs.

Patients routinely recorded the

severity of their pain on a Visual

Analog Scale (VAS) ranging from

0 to 10 (0=asymptomatic) on

admission & after 5 days.

Clinical details were recorded

from their notes. Time over 30

months.

2 patients died as a result of progressive

illness within a week after application. The

remaining 15 patients showed an

improvement on VAS: 12/17 (70.5%)

improved 4+ points. Mean VAS improved

from 9.4 to 4.6 after treatment (p=<0.02).

Conclusion: diamorphine-Intrasite gel may

be an effective treatment for open PrUs in

palliative care setting & general medicine

units.

More research needs to

be done to address the

possibility of long-term

tolerance, intact skin pain

response, & the right

dose & type of topical

opiods.

Brink P, Smith TF,

Linkewich B. Factors

associated with

pressure ulcers in

palliative home care. J

Palliat Med.

2006;9(6):1369-75.

Retrospective

exploratory study

(March 2002 –

December 2004).

Adult home care clients

(n=561) with terminal

cancer diagnosis

receiving palliative

home care from

Canadian Government

agency, with prognosis

of 6 weeks or >. Sample

of 49% males (n=277)

and 51% females

(n=281) (3 missing).

Average age 69 years.

Pressure ulcers

Health information gathered

on 561 home care clients

March 2002 – Dec 2004.

InterRAI is designed for

palliative care & includes

psych, physical, social &

spiritual well-being. 32

month study.

InterRAI PC comprehensive

assessment form, Cognitive

Performance Scale, ADL-

Hierarchy Scale, MDS-

Depression Rating Scale, Pain

Scale, Pressure Ulcer, &

prognosis.

PrU prevalence 10.5% (59/549). Stage I

=51.7%, Stage II=33.3%, & Stage III=13.3%.

On chi-square, variables associated with PrU

prevalence 10.5%, with 57.1% Stage I, 33.3%

Stage II, 13.3% Stage III. PrU+ patients were

associated with variables of male gender,

urinary & bowel incontinence, catheter &

ostomy care, new pain site, SOB, inability to

lay flat d/t SOB, insufficient nutritional

intake, age, poor cognition, & poor ADLs. On

logistic regression, male gender, inability to

lay flat d/t SOB, catheter or ostomy care, &

poor ADLs were independent factors

associated with a PrU.

Specific focus on clients

with terminal cancer with

prognosis >6 weeks,

limiting generalizability,

as palliative care offered

to all home care clients

regardless of prognosis.

Retrospective use of

cross-sectional data.

Brown G. Long-term

outcomes of full-

thickness pressure

ulcers: healing and

mortality. Ostomy

Wound Manage.

2003;49(10):42-50.

Retrospective

correlational study

for 5 year period

(1998-2002).

Medical records for 74

inpatients (1 female)

who developed FT

pressure ulcers in a VA

Med Center (acute care,

intensive care, long

term care)

Structured review of

computerized medical record

data.

180 day end point from date of

PrU onset.

68.9% died within 180 days of 1st detection

of PrU, 1 year mortality rate 78.4%, 2-year

mortality 83.8%. 180-day mortality for acute

care 75%, ICU 66.7%. Average number days

from PrU onset to death 47 days (SD 40).

66% of PrU were sacral, 16% heels. No PrU

healed in those who died within 180 days.

Chaplin J. Pressure

sore risk assessment in

palliative care. J Tissue

Viability.

2000;10(1):27-31.

Comparative analysis

of professional

judgment of

experienced

palliative care

nurses.

Methodological

study.

Comparative analysis of

professional judgment

of experienced

palliative care nurses

via who did 529 risk

assessments on 291

patients.

Pressure ulcers

Tool developed over 18

months

Relationship between nurses

rating of low, medium, high risk

to same nurse rating on risk

assessment tool. Validity &

reliability developed.

No analysis presented on the validity of

measures. Validity: identified 4 thresholds of

risk: 11 & =low risk, 12-17=medium risk,

18-21=high risk, 22 & =very high risk. Inter-

rater reliability currently being established.

Hunters Hill Marie Curie Centre Risk

Assessment Tool developed which has 7

subscales: sensation, mobility, moisture,

activity in bed, nutrition/weight changes,

skin condition & friction/shear.

Significant limitations,

same nurses used

professional judgment &

also rated with the risk

assessment tool. No

attempt to quantify tool

validity. No statistical

analysis of relationship

between judgment & tool

rating. No reliability


161


Length of Follow-up

Results Limitations

testing of tool. For a

methodological study,

limited evidence/lit

review to support the

tool development. No

info on how many,

education level, age,

experience of any of

nurse raters involved in

the study.

Eisenberger A, Zeleznik

J. Pressure ulcer

prevention and

treatment in hospices:

a qualitative analysis. J

Palliat Care.

2003;19(1):9-14.

Qualitative study,

using constant

comparative analysis.

Participants were 18

directors of clinical

services, 9 were MDs &

9 were RNs, & 10 direct

care nurses (mean 18

years total experience

& mean of 4 years in

hospice). None had

advanced practice

training in wound care.

No hospices would give

out family or patient

names so no interviews

done of these people.

Pressure ulcers

Telephone survey. Saturation

reached after 28 individuals

from 17 hospices were

interviewed.

Telephone survey of questions

based on Medline &

bibliographic review of

literature. Face validity

established, it was pilot-tested

on 2 physicians & 5 nurses with

experience in wound and end-

of-life care, & family member of

patient who died with a PrU.

Revisions made. Three versions,

1 for directors, 1 for

Direct-care nurses, & 1 for

family.

Conflicts exist between efforts to prevent &

treat PrUs in patients at end-of-life & can be

painful. Comfort may supersede prevention

& wound care when patients are actively

dying or have conditions causing them to

have a single position of comfort. Complete

ulcer healing was appropriate goal for some

hospice patients. Family caregivers face

additional burdens when PrU develops.

Frequent theme was single position of

comfort. Sharp debridement felt to be too

aggressive. New PrUs are inevitable & don’t

reflect poor care or negligence. Turning,

repositioning, and dressing changes seen as

additional sources of pain, & can forgo these

if they cause too much pain.

Only US hospices

included. Lacked direct

report from patients &

family caregivers.

Flock P. Pilot study to

determine the

effectiveness of

diamorphine gel to

control pressure ulcer

pain. J Pain Symptom

Manage.

2003;25(6):547-54.


Randomized, double-

blind, placebo-

controlled crossover

pilot trial. Patients

served as own

controls.

Sample=13 patients

from inpatient hospice

unit admitted over 7

months (mean age 77

years, 10 females).

Seven patients

completed study.

Inclusion criteria: Grade

II or III painful PrU, to

be inpatient for 1 or >

weeks. Exclusion

criteria: Grade I or IV

PrU, non-PrU. 12 on

sacral area, 1 heel, 62%

Stage II, mean size

9cm2.

Random assignment to 1 of 2

treatment sequences: 3 days

of IntraSite gel followed by 3

days of diamorphine gel, or

vice versa. IntraSite gel is

ready-mixed HDG & used as

placebo. Diamorphine gel

(0.1% weight to weight

mixture) was mixed with

IntraSite gel. Gels applied

1x/day & covered with

standard dressing. All

patients had pressure

relieving cushions &

mattresses & encourage to

change positions frequently.

Pre-trial, PrU location, size &

stage were documented.

Prior to study entry PrU size,

location, stage was recorded.

Pain assessed before, 1, & 12

hours after gel application by

nursing staff blinded to

treatment sequence. Patients

rated pain as none, mild,

moderate, or overwhelming &

this translated to scores of 0=no

pain to 4=overwhelming. Nurses

checked 1x/day for skin

irritation, pruritus, constipation,

nausea and/or vomiting,

drowsiness, hallucinations,

myoclonus jerking, respiratory

rate. Follow-up was 3 and 6

days.

Seven patients completed study (5 died, 1

became confused). Pain scores similar

before IntraSite & diamorphine gel

applications. Pain scores improved

significantly 1 (p=0.003) and 12 hours

(p=0.005) after diamorphine gel application

compared with placebo/baseline. Four

patients were pain- free after 1 hour & 3

after 12 hours. No significant difference in

occurrence of side effects between groups

at 1 or 12 hours. No difference in systemic

pain med in the 2 groups. Symptoms of

opioid toxicity similar in both groups.

Side effects not studied.

Small sample size (but

pilot study). High attrition

rate.

Galvin J. An audit of Quality improvement Sample of 542 patients Medical record audit. Two years. Average LOS 15 days with 2% (n-11) staying Data verification done by


162


Length of Follow-up

Results Limitations

pressure ulcer

incidence in a

palliative care setting.

Int J Palliat Nurs.

2002;8(5):214-21.

P & I study.

Two-year continuous

audit of PrU

incidence on 16-bed

specialist palliative

care unit.

Retrospective check

of chart for why PrU

developed, stage

when first noted, and

action(s) taken.

admitted to palliative

care unit over 2 years

(2000-2001) with mean

age 68 (range 35-90).

Pressure ulcers

Researcher-designed data

collection form placed on

chart within 6 hour of

admission for info on any

pressure damage, size,

appearance, treatment,

Waterlow Score, mattress &

seating surfaces, handling

aids. Info r/t PrU updated

weekly & on discharge.

Documented # of patients

with PrU, # developing in

unit, distribution & severity

of PrU, % of patients

discharged with PrU.

Waterlow Pressure Sore Risk

Assessment Tool used to assess

risk; Stirling Pressure Sore

Severity Scale (SPSSS) used to

grade pressure damage.

Researchers tracked missing

patients & relevant data.

>50 days. 44% died on unit (n=240). Average

age of patient developing PrU was 69 years

& average LOS 26.5 days. Average percent of

patients admitted with PrU was 26.1%. PrU

incidence was 12%

Retrospective analysis: patients who

developed PrU were older, stayed 12 or >

days, and more of these died than those

without a PrU. 95.3% were “accurately”

assessed as high or very high risk on

Waterlow Tool and 89.2% of PrU were

Grade I or II. Of all PrU, 78.4% were sacral,

and position of tumor as well as comfort &

positioning difficulties considered as most

often responsible. In spite of this

knowledge, superficial PrU still developed.

potentially biased unit

staff. Prevalence

calculation not given &

this is confused more by

author summing P & I

rates during discussion to

talk about percent of all

patients with some level

of PrU damage. No data

on how incidence was

calculated. Limited

demographic data

presented.

Hanson D, Langemo

DK, Olson B, Hunter S,

Sauvage TR, Burd C, et

al. The prevalence and

incidence of pressure

ulcers in the hospice

setting: analysis of two

methodologies. Am J

Hosp Palliat Care.

1991;8(5):18-22.

Descriptive study

with retrospective &

prospective

components in

outpatient hospice

agency.

Prospective sample for

prevalence = 8 & for

incidence =19;

retrospective incidence

= 61 over 9 months.

Only adult patients

included. Patients with

a current PrU excluded

from incidence portions

of study.

Pressure ulcers

Phase I Prevalence: all

patients assessed on 1

specified day; Phase II

Prospective Incidence: all

adult patients PrU free

patients screened on

admission & reassessed q

week x 4 week or until death

or discharge if prior to 4 wk.

Retrospective Incidence: all

adult patients PrU free on

admit over 9 month period

were included & charts

audited for PrU incidence

post-admit.

See previous column. Tools

included Braden Scale for

Predicting PrU Risk, a skin

assessment tool, &

demographic data form.

Reported Braden interrater

reliability r=.99 for RNs (all staff

were RNs), & was r=.99 for this

study. NPUAP 1989 PrU stages

used. Demographic data

included sex, age, marital &

ethnic status, smoking history,

steroid therapy, type of bed &

bed overlay used, &

incontinence data.

Prospective prevalence = 13% (1 of 8

patients), prospective incidence = 0% (0 of

19 patients); retrospective incidence =13%.

Stage of PrU were I=6 and II=2; 6 in men & 2

in women. PrU location: sacrum=5 (38.4%),

elbow=4 (30.7%), heel=2 (15.4%) m & ischial

tuberosity & trochanter 1 each. Mean days

of PrU occurrence post-admit was 45.5 (3-

139), 5 of 8 (62%) of PrU occurred within 2

week of death. 25% each were incontinent

of urine & of feces, 37% were on steroids, 7

of 8 patients had static air matts on bed & 1

had egg crate. Mean age was 68.6 year.

Small sample size & done

in semi-urban Midwest

area. Prospective

methodology needs to be

longer than 4 weeks of

follow-up; therefore for

this study the

retrospective incidence

was more accurate.

Hatcliffe S, Dawe R.

Clinical audit:

Monitoring pressure

sores in a palliative

care setting. Int J

Palliat Care Nurs.

1996;2(4):182, 4-6.

Prospective point

prevalence survey

study.

All patients included on

palliative care unit on

day of survey over 4

months (same day each

month). N=151. No

patients included >1x.

Pressure ulcers

Point prevalence survey same

day q month x 4 mo.

Waterlow Risk scale used along

with PS stages and

presence/absence of pain on 4

point scale (no pain, mild,

moderate & severe pain)

On Waterlow, 100 of 151 or 66% of patients

at high or very high risk, indicating

vulnerability of sample. Yet, 59% of patients

at high risk & 37% at very high risk had

intact skin. Most PrU were sacral (64%) &

heel (20%). 65% were Stage I-II, 17% Stage III

& 18% Stage IV-V. 52% had no pain, 30% had

mild, 13% moderate & 5% severe pain. PU

prevalence varied from 16-28% & incidence

3-9%. Averages of 30% of PrU developed

post-admit.

Could not factor in effects

of early preventive

interventions &

treatments; Waterlow

Scale not for palliative

population; did not

compare PrU

development with

proximity to death.

Masaki F, Riko K, Seiji

H, Shuhei Y, Aya Y.

Evaluation of pressure

Retrospective study,

from 2003 through

2005

Subjects were 202

patients with cancer

and 217 patients

All 419 patients who

developed a PrU from 2003

through 2005 were treated

All 419 patients who developed

a PrU from 2003 through 2005

were treated until healed or

36% of cancer group patients died & 15% of

non-cancer group. Mean healing time for

cancer group 19 days & those without

Retrospective format

limited to accuracy &

completeness of


163


Length of Follow-up

Results Limitations

ulcers in 202 patients

with cancer -- do

patients with cancer

tend to develop

pressure ulcers? Once

developed, are they

difficult to heal?

Wounds.

2007;19(1):13-9.

without malignant

disease who developed

a PrU. All were treated.

Patients with cancer

ranged from 3 month –

94 years (mean=66.2),

patients without cancer

were 28-92 years

(mean=68), with NSD.

until healed or patient died

as result of PrU.

patient died as result of PrU. cancer 18.8 days (NSD). Most PrUs in both

groups were Stage I at 1st discovery; sacrum

was site for 76-77% of PrUs. Patients whose

underlying disease is cancer more likely to

develop PrUs. Stat sig diff on Ohura scale for

patients with & without cancer ( score,

risk). Incidence of PrU in patients with

cancer has increased over past 3 years.

documentation.

McDonald A, Lesage P.

Palliative management

of pressure ulcers and

malignant wounds in

patients with

advanced illness. J

Palliat Med.

2006;9(2):285-95.

Review.

Comprehensive

search of MEDLINE,

CINAHL & Cochrane

Databases. Focus on

overview of general

principles of

palliative

management of PrUs

& malignant wounds.

Pressure ulcers No search terms given,

no search strategies

given, no dates for search

given, no number of

articles included in

search, unable to

evaluate as any level of

evidence d/t significant

limitations.

Munter KC, Beele H,

Russell L, Crespi A,

Gröchenig E, Basse P,

et al. Effect of a

sustained silver-

releasing dressing on

ulcers with delayed

healing: the CONTOP

study. J Wound Care.

2006;15(5):199-206.

Note: not all were

PrUs

Also in Table 4 Pain &

Table 9 Dressings

Comparative open

prospective parallel

& block-randomized

study. Total 18mo

study period.

N=619

Inclusion: 18 or >, not


chronic wound with

delayed healing & mod-

high exudates

Exclusion: depth

<0.5cm

8% were PrUs.

Patients Randomized to

either silver foam or LBP &

followed weekly for 4 wks.

At q visit wound assessment

made & dressing chg.

HRQoL at 1st & final visits

done.

Endpoints in ulcer size,

exudates, or change in

wound bed composition,

HRQoL, cost effectiveness

Pain measured on 10-point

scale, measured at q dressing

change

Median rating of pain at dressing changes

in silver foam than LBP group (p<.0001 week

1, p<.0011 week 2) & in between dressing

changes.

Silver foam group had > in wound area

(58.5% v 33.3%), less maceration, better

exudate management, & faster in odor

than LBP group.

LBP included a multitude

of dressings, thus large

sample required to offset

this.

Reifsnyder J, Magee

HS. Development of

pressure ulcers in

patients receiving

home hospice care.

Wounds.

2005;17(4):74-9.

Pilot study to identify

prevalence &

incidence of PrU &

test algorithm for

PrU prevention &

management.

4 home hospice

programs Oct-Dec 2003.

Excluded LTC residents.

N=980

Pressure ulcers

Prevalence rates calculated

from Jan-June 2005 (6

month), demographic data;

Karnofsky/Palliative

Performance Scale (PPS),

Braden Scale scores.

PrU prevalence (period) PrU period prevalence 26.9%. Average

patient 75, average LOS 84 days, mortality

rate 81.2%. PrU incidence 10%. Patients who

developed PrU sig older. Patients who

developed PrU had cancer (50%), CNS

disorder/dementia (18.2%), CVD (13.1%),

etc. Non-cancer patients disproportionately

developed PrU. Patients who developed PrU

Prevalence was

retrospective; incidence

reported and not directly

assessed by researchers

(although agency

pharmacist did reporting)


164


Length of Follow-up

Results Limitations

had higher risk on Braden scale & mean

Karnofsky scores significantly lower for

patients with PrU as compared to those

without.

Reifsnyder J,

Hoplamazian LM,

Maxwell TL. Preventing

& treating pressure

ulcers in hospice

patients. Caring.

2004;23(11):30-7.

Retrospective (6

month review) &

prospective (3

month) study. Did

pre- and post-pilot as

well as baseline

studies of PrU

prevalence &

incidence in home

hospice patients I

Hospice Pharmacia,

October-December

2003. HP serves

approximately 20%

of all US hospice

patients.

Oct – Dec 2003 in 4

hospice sites; 980

hospice home patients.

Average age 75 year.

Cancer was diagnosis

for 62.3% of patients.

Pressure ulcers

Retrospective data collected

from PrU logs & med records.

Baseline data collected via

survey form completed by all

primary nurses, prospective

data gathered by structured

phone interview to nurses by

pharmacists. PrU prevalence

audits; LOS; demographics;

diagnosis;

PrU prevalence rates for pre-,

baseline, and post-pilot studies;

incidence for 6-month

retrospective & 3-month post-

pilot studies.

PrU prevalence 14.6% in 6-month

retrospective study; 17.5% baseline; 26.9%

3-month study period. 3-month study PrU

incidence 10%. 50% Stage II. Mortality rate

81.2%; average LOS 84 days (range 1-1123

days) for those who died during study;

median LOS 31 days; average

Karnofsky/Palliative Performance Score 40.

Patients with cancer dx had fewer PrU than

patients without cancer dx (CNS disorders,

dementia). Group with higher PrU

occurrence were those with CVA or

dementia. Distribution of PrU stages similar

in Pre- and Post-pilot studies. Most PrU

Stage II (50%), Stage I=25%, Stage III=12%,

Stage IV=9%.

Retrospective studies

limited by accuracy &

thoroughness of data

documented. No

statistical analyses

reported for comparing

different time points or

diagnostic categories.

Limited demographic info

on subjects (no gender,

ethnicity/race, etc.). No

specifics given for how P

& I calculated for study.

Use of 4 agencies could

have limited consistency

in data collection &

interpretation.

Sopata M, Luczak J,

Ciupinska M. Effect of

bacteriological status

on pressure ulcer

healing in patients

with advanced cancer.

J Wound Care.

2002;11(3):107-10.

Prospective,

randomized trial.

34 patients with

advanced cancer (18 F,

16 M) & Stage II-III PrU,

24-88 (mean 59 year)

years old. Inclusion

criteria advanced

cancer & life

expectancy >8 year,

Exclusion criteria poor

general condition, Hgb

<7mmol/l & albumin

<2.5g/dl, use of

corticosteroids

Pressure ulcers

Randomly allocated to

Lyofoam/polyurethane foam

or Aquagel/HDG dressings &

dressings changed based on

clinical need. Noted efficacy,

treatment times & healing

rates. Study time 8 weeks or

until ulcer healed, and was 3

year study (Jan 1996 – Jan

1999). All patients cared for

at Palliative Care Dept.

Dressings changed according

to clinical need. All patients

treated by 1 of 3 nurses.

Qualitative analysis of 38 PrU &

quantitative bacteriological

studies on 19 PrU at baseline &

3 wks. Study time was 8 weeks

or until ulcer healed. Examined

bacterial growth under 2

occlusive dressings.

No SSD between 2 treatment groups in

efficacy, healing rates & treatment times

Bacteriology identified 92 species, but did

not cause any clinical sign of infection.

Bacteria cultured in every PrU. Types & # of

bacteria did not correlate to PrU stage or

dressing used. 80% aerobic & 20%

anaerobic, most common were Staph,

Enterococcus faecalis & Strep Pyogenes.

Neither the Staph species nor anaerobes

caused any clinical symptoms of infection or

affected efficacy, treatment times, & healing

rates.

Small sample size limited

generalizability. Five

patients died after 3rd

week assessment so were

included in analyses.

Tippett AW. Wounds

at the end of life.

Wounds.

2005;17(4):91-8.

Cross-sectional &

retrospective records

review. Two studies:

Prevalence study in

2003 (A),

retrospective chart

review in 2004 (B)

Study A: 383 patients in

large suburban hospice

during 2 week period in

2003 of which 2/3 were

nursing home residents.

Study B: Retrospective

med record review of

192 consecutive

patients referred to MD

Study A: Primary care RNs

reported # of patients who

had a Stage I-IV PrU or other

skin issue over 2-week period

mid-March-early April 2003.

Study B: Structured

retrospective audit of

patients referred to MD

wound consultant over 2 ½

Study A: PrU prevalence rate

over 2 wks.

Study B: characteristics of

patients with wounds, type of

wounds, etc.

Study A: PrU prevalence 17.5% or 50% of the

35% of patients who had a “skin issue.”

Study B: Average age 82 years, 2/3 were

female, & 18% Black. Average hospice LOS

82 days, malnutrition present in 71% of

patients, & 2/3 of patients had multiple

wounds (not all PrU). Most common co-

morbidity dementia (45%), then stroke, PVD,

&DM/cancer. 70% of patients had a PrU &

Retrospective audit

limited by completeness

& accuracy of

documentation. Limited

to patients in one large

metropolitan area, thus

may not be generalizable.

No training of nurse data

collectors, therefore type


165


Length of Follow-up

Results Limitations

wound consultant with

mean age 82 years, 67%

female, 18% black,

during 2.5 year periods

2001-2004.

Pressure ulcers

year period, Sept 2001 –

March 2004, for wound

evaluation & treatment.

PrU were 40% of all wounds. Most wounds

on sacrum.” Wounds are predominantly an

end-of-life phenomenon,” & are a significant

problem. “PrUs are almost inevitable in this

frail population. PrUs risk is increased with

poor nutrition, immobility, loss of cognitive

function, and incontinence – all of which are

seen in the end-of-life population.”

“Wounds are strikingly a cardiovascular

phenomenon.” PrUs were mostly Stage II-IV

& necrosis & gangrene highly prevalent.

“Nutritional support…for the majority of

patients was not achievable due to patient

inability, refusal, or lack of availability.”

& number of wounds

with nurse bias may be

inaccurate. Nursing home

patients represented 2/3

of patients. Prevalence

conducted over 2 week

time period rather than 1

day (when nurses able to

see their patients). Some

patients had no follow-up

visit. Prevalence over 2

week may have been

under or over reported.

No attempt to separate

home & NH patients. No

demographic data.

B: problems with missing

data, no data on how far

back each medical record

was reviewed, no follow-

up notes in med record,

almost all were NH

patients, so may be more

reflective of NH sample

than home care or

hospice patients.

Walding M, Andrews

C. Preventing and

managing pressure

sores in palliative care.

Prof Nurse.

1995;11(1):33-4, 7-8.

Pre- post-

intervention study of

PrU prevention

protocol.

20-bed inpatient

hospice unit. Pre-

intervention

sample=115. All in-

patients participated.

90% of patients have

malignancy.

Pressure ulcers

PrU Prevention protocol of

risk assessment (Waterlow

Scale), wound assessment

(Morison’s wound-care chart

& Torrance’s grading systems

used), & dressing protocol

(Grade III treatment with

HDC or alginate). Two

teaching sessions done to

orient staff to protocol). Each

nursing team had PrU

resource nurse.

Retrospective pre- intervention

incidence, 3,6, 12, & 24 month

follow-up.

Pre-intervention, retrospective incidence

43% (60% present on admit & 40%

developed on unit). Did 3, 6, 12 & 24 month

incidences after implementing PrU

Prevention protocol. Post-Incidence rates

were: 3 month=28%, 6 month=38%, 12

month=26%, 24 month=21%. Pre-

intervention 40% of PrU developed in

hospital & also at 24 month, but was only

17% at 3 month. Pre- no Risk Assess scores

recorded, & by 6 month post 100% of scores

treated according to protocol & PrU

incidence 21%. Nurses motivated by

protocol & felt PrU were being better

managed.

Retrospective data in

some areas throughout

study. Unable to

ascertain if charted

treatments were actually

done.


166


Length of Follow-up

Results Limitations

Baharestani MM. The lived

experience of wives caring for

their frail, homebound, elderly

husbands with pressure ulcers

[see comments]. Adv Wound

Care. 1994;7(3):40-2, 4-6, 50

passim.

Spiegelberg’s

phenomenologic

al method -

qualitative

Six Caucasian

wife/caregiver

to spouses with Stage

III-IV PrU & bedridden

or chair fast. Mean

age 76.5 year (range

69-82), all had

arthritis, 67% HTN,

50% severe back

problems, 50% taking

tranquilizers. Provided

care to husbands 2-10

year. Husbands mean

age 80.6 year (73-

88.5). All had fecal

incontinence, 50%

B&B incontinence, 2

had a Foley, 1 had

intermittent caths. No

Stage I or II PrUs, none

receiving >20hr/week

HHA. All were bed or

chair-fast &

dependent in ADLs.

Semi-structured, face to

face, audio- taped interview

with wives. Field notes

taken. Each wife asked 8

questions. Demographic

info also obtained.

180 day end point from date of

ulcer onset. Interviews transcribed

verbatim, data coded, & subjected

to intense analysis. Validity check

on data coding & thematic ID done

by 5 nurses & agreement

ascertained; then for validation, 5

wife caregivers verified thematic

analyses accurately described their

experience.

5 major themes & 2 minor recurring

sub-themes. Themes: difficult

caregiving (physical fatigue,

emotionally difficult to see spouse

debilitated, heavy physical safety/care

needs, financial difficulties) frailty of

caregiver CG only health maintenance

was taking prescription meds & seeing

own MD), limited socialization (only

respite when husband hospitalized),

limited social support systems (HHA

viewed as too costly & no adult kids

involved in direct physical care) &

limited care giving knowledge (care

giving learned by experience).

Subthemes were fear regarding the

future & symbolic meaning of the PrU.

None felt financially able to afford 24

hour assistance, NH placement not

desired, future feared. PrU viewed as

normal outcome of being bedbound

but felt “blame” from staff when

husband hospitalized.

Limited to Caucasian

wives, elderly (>60), NY

area. Need replication in

other ethnic groups &

rural areas. Not

followed longitudinally.

Bale S, Dealey C, Defloor T,

Hopkins A, Worboys F. The

experience of living with a

pressure ulcer. Nurs Times.

2007;103(15):42-3.


Qualitative pilot

study,

Heideggarian

phenomenology

with

interpretative

phenomenologic

al analysis.

Eight older adults from

4 centres, 3 in England

& 1 in Belgium.

Inclusion criteria

included older adults

with stage 3 or 4 PrU;

exclusion criteria were

spinal cord injury &

inability to provide

informed consent. Age

range 68-101.

Participants had other

co-morbidities.

Unstructured interviews

which acknowledged the

contribution of both the

participant & researcher.

Three main themes with

associated sub-themes.

Three main themes of endless pain, a

restricted lifestyle, & coping with the

PrU. Pain was constant & severe

feature & analgesia not always

effective. Pain prevented proper rehab

in some. Cycle of pain, not pain itself

was endless. Severity of pain not

always recognized by MD. Pain by

repositioning (conflicts with best

evidence on frequent repositioning),

lie still, pain relieving equipment. Pain

was restricting feature with significant

impact on life & feelings re: self.

Worried, depressed feeling

burdensome, inadequate & sense of

powerlessness. Disliked their

dependence on others & change from

former life. Odor was impacting them.

Social life & general activity

Researchers felt design

fitting to multiple

settings. Limited to

older adults and limited

number of participants.

May not be

generalizable

worldwide.


167


Length of Follow-up

Results Limitations

restrictions were the worst part.

Impact on s/o & family. PrU also

caused extended hospital stay. Coping

with PrU & the consequences

facilitated thru comparing self with

others “who had it worse.” Acceptance

of situation with some fatalism, &

positive thinking seen as part of

getting on with their lives.

Bale S, Tebble N, Price P. A

topical metronidazole gel used

to treat malodorous wounds. Br

J Nurs. 2004;13(11):S4.

Level

Quality: Strong

Randomized,

double-blind,

placebo-

controlled design

N=41. Group 1=20

(Metronidazole),

Group 2=21 (placebo).

Inclusion: malodorous

wounds, able to rate

wound odor,

Exclusion: unable to

rate wound odor

Wound dressed daily with

gel & secondary dressing.

Assessed at 4 points in time

(baseline, days 1, 3, 7 or

when odor resolved,

whichever was sooner.)

Assessed at 4 points in time

(baseline, days 1, 3, 7 or when

odor resolved, whichever was

sooner.)

Symptom ratings & Semantic

Differential Scale (SDS) ratings

done at days 0, 1, 3 & 7, adverse

events recorded, State-Trait

Anxiety Scale at baseline & days 3

or 7. Demographic data recorded.

Patients, 2 study nurses, &

relatives/carers completed

questionnaires at days 0,1,3,7,

Symptom ratings & Semantic

Differential Scale (SDS), State-Trait

Anxiety Scale all have good validity

& reliability.

Sample size of 20/group for 90%

power with 95% confidence, assuming

0-10% rate of success in placebo group

& 50-60% success in metronidazole

group.

NSD between groups on age, weight, &

height; on frequency of treatment for

4 classes of wounds.

Was 100% success rate for

metronidazole group, mostly within 3

days & no adverse events; 76% success

rate in placebo group, & NSD between

groups. Patient & nurse odor ratings

sig correlated (p<.001), NSD in mood

state between groups over time.

Assessments were

subjective, as no

objective tools

available. Ethical

challenges related to

odor & use of placebo

group.

Decrease in odor in

placebo group may have

been due to frequency

of dressing changes.

Krajnik M, Zylicz Z, Finlay I,

Luczak J, van Sorge AA. Potential

uses of topical opioids in

palliative care--report of 6 cases.

Pain. 1999;80(1-2):121-5.


Case review Six cases of patients

treated with topical

opioids. Cutaneous

pain due to tumor

infiltration, skin ulcers

of malignant & non-

malignant origin,

severe oral mucositis,

pain d/t knee

arthrosis, & severe

tenesmoid pain.

Variety of skin ulcers

Case review. Patients

received 0.1% morphine gel

Pain relief Patient. A: (89 y/o) with 3x7cm painful

& inflamed subq upper tibial infiltrate.

Pain 4-8 pre- and 0-2 post. Patient B:

(56 y/o) cutaneous pain with sacral &

colostomy infiltration. Pain pre4-10

and post- 1 until last week of life it was

occasionally 6. Patient C: (71 y/o)

severe oral mucositis, pain pre- 10 &

post- 2-4. Patient D: ((71 y/o) painful

necrotic leg ulcers, pain pre- 10 & post-

4. Patient E: (69 y/o) with cancer of

larynx, pain pre- 9 & post- 2-4. Patient.

F: (62 y/o) vulvar cancer, pain pre- 6 &

post- 2. Opiod receptors are inactive in

non-inflamed tissue. After onset of

inflammation, opioid receptors

become activated within hours.

Morphine & diamorphine appear to do

Observation periods

were short. Application

of gel to open wound is

difficult, especially with

much exudates, & much

of drug may be flushed

away. Need to identify

how morphine

absorbed through

healthy skin, as is poor

thru intact epidermis,

but when epidermis

removed, bio-

availability is 75%. Is

morphine absorbed

systemically rather than

locally?


168


Length of Follow-up

Results Limitations

equally well.

Langemo DK, Melland H, Hanson

D, Olson B, Hunter S. The lived

experience of having a pressure

ulcer: a qualitative analysis. Adv

Skin Wound Care.

2000;13(5):225-35.


Spiegelberg’s

phenomenologic

al method –

descriptive,

qualitative

Non-probability,

purposive sample of 8

respondents, 4 with

PrU & 4 with previous

PrU (Stage II-IV). Four

had SCI & 5 had

surgical flap

reconstruction; 2 had

MS, 1 was bipolar,

alcoholic, & 1

degenerative

neuromuscular

disorder. Males=7,

female=1, mean age

35.7 year, range 27-52

year. 6 of 8 had

multiple PrU, all 4

current patients with

PrU were Stage IV

Unstructured, face to face,

audio- taped interviews.

Field notes taken. Each

person asked to respond to

“Please describe your

experience of having a PrU.

Share all the thoughts,

perceptions, & feelings you

can recall until you have no

more to say about this

experience.” Used relevant

probes to elicit additional

data. Demographic info also

obtained.

Interviews transcribed verbatim,

accuracy verified. 3 researchers

ensured content validity. Colaizzi’s

content analysis established via

reading transcriptions, extracting

significant statements & phrases

directly r/t lived experience,

meaning formulated from

significant statements & phrases,

formulated meanings organized

into clusters of themes, &

researchers integrated results into

exhaustive description of the lived

experience.

7 themes emerged: perceived etiology

of PrU, life impact & changes (physical,

financial & social), psycho-spiritual

impact (body image changes, struggle

with stereotypes, desire/struggle for

control & independence, spiritual

impact), extreme painfulness with PrU

(pain Intensity & duration, analgesic

use), need for knowledge &

understanding (knowledge of

prevention, physiologic processes &

lack of knowledge), need for & effect

of numerous stressful treatment (self-

care, treatment regimens & multiple

surgeries, complications, length of

healing time), & grieving process

(denial, depression, anger, bargaining,

acceptance).

Limited to Caucasians,

young or middle age, in

Midwest area of US.

Need replication in

other ethnic groups &

urban areas. Not

followed longitudinally.

Vanscheidt W, Münter KC,

Klövekorn W, Vin F, Gauthier J,

Ukat A. A prospective study on

the use of a non-adhesive gelling

foam dressing on exuding legs

ulcers. J Wound Care.

2007;16(6):261-5.


Pre- Post,

Prospective open

label

comparative

study.

N=46

50% male, 50% female

Inclusion: heavily

exudating leg ulcer

Exclusion: sensitivity

to GFD-N, history poor

adherence, arterial

ulcer, required wound

filler on enrollment

Baseline data, pain level,

peri-ulcer skin info

collected. Wound cleaned,

debrided & measured.

Subjects’ treatment with

non-adhesive gelling foam

dressing & compression for

28 days & pain assessed. At

least weekly clinic visits.

Outcome measure=pain intensity

rated on VAS 10-point scale.

Length of follow-up 28 days or

withdrawal from study, whichever

came 1st.

Primary endpoint safety, 2nd

endpoint measures of dressing

performance, exudates

management, ease of use &

pain/comfort.

Mean pain VAS intensity rating >50%

for 1st clinic dressing change compared

to pre-study (4.7 v 23, p<.001) & on

removal (3.9 v 1.7, p<.001). Peri-

wound skin condition better for 31%

(p=0.006). GFD-N dressing associated

with SSD in ulcer pain with dressing

in place & during removal. Of 46

subjects, 11% healed the ulcer & 78%

improved in 4 or < wks.

GFD-N was safe, effective &

convenient for wound healing,

exudates management, pain/comfort

& ease of use.

Subjects used as own

control, no RCT, no true

control group.

Documents

Final 2009 Treatment Technical Report1