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Volume 2Number 1Spring 2002

Published byEuropeanWound ManagementAssociation

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EWMA JOURNAL 2002 VOL 2 NO 12

The EWMA JournalISSN number: 1609-2759

Volume 2, No. 1. Spring, 2002

The Journal of the EuropeanWound Management Association

Published twice a year

EditorE. Andrea Nelson

Editorial BoardMichelle BriggsCarol Dealey

Brian GilchristFinn Gottrup

Deborah HofmanSylvie MeaumePeter Vowden

Legal ResponsibleChristine Moffatt

EWMA Homepagewww.ewma.org

For membership application,correspondence,

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The next issue will be published inFall 2002. Prospective material for

the publication must be with theeditors as soon as possible and in

no case later than September 20.The contents of articles and letters

in the EWMA Journal do notnecessarily reflect the opinions of

the Editors or the EuropeanWound Management Association.

The copyright of all published materialand illustrations is the property of

the European Wound ManagementAssociation. However, provided prior

written consent for their reproduction isobtained from both the Author and

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state where the material is to bepublished, and, if it is abstracted,summarised, or abbreviated thenthe proposed new text should besent to the EWMA Journal Editor

for final approval.

EWMA news

Scientific Articles

Clinical Articles

Conferences

Organisations

EWMA Council

For contact addresses, see www.ewma.org

Carol DealeyGeorge CherryMichelle Briggs

Volfgang VanscheidtJoan-Enric Torra Bou

Madeleine Flanagan Peter Franks Deborah Hofman

Geoff Keye Christina Lindholm Sylvie Meaume

Christine MoffattPresident

Peter Vowden,President Elect

Finn GottrupImmediate Past Presi-

dent, Recorder

Marco Romanelli

Brian GilchristSecretary

E. Andrea NelsonTreasurer, Editor

3 Editorial

5 Health Related Quality ofLife MeasurementE. Andrea Nelson

9 The use of Compression Therapyin the Treatment of VenousLeg Ulcers a recommendedManagement Pathway

Michael Stacey et al15 The Professional Role and

Competence of Tissue ViabilityNurses in FinlandSalla Seppnen

21 A Review of Advances in FungatingWound Management sinceEWMA 1991Patricia Grocott

27 Multi-center Research on WoundManagement in Home Care in ItalyA. Bellingeri

32 Wound Healing in Moorish SpainCarol Dealey

36 Thank you Christine Moffatt37 Welcome to Wolfgang Vanscheidt38 Treatment studies from 200141 Book Review

Guide to the Medical Literature.A Manual for Evidence-BasedClinical Practice

Sally Bell Syer

42 Conference Calendar42 Ewma Conference History43 The 11th Annual Meeting of the

European Tissue Repair SocietySeptember 2001 Cardiff UKGeorge W. Cherry

44 The Cochrane Collaboration47 European Co-operation48 Co-operating Organisations55 EWMA Information

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EWMA JOURNAL 2002 VOL 2 NO 1 3

Standing onthe shoulders of

giants

Wound management, research and

education is the business of thousands

of professionals across Europe. Nurses in

every European hospital need to know about reliable

strategies for determining whether their patients are atrisk of pressure damage, and cost-effective interventions

to prevent pressure damage. Surgeons are faced every

day with choices about surgical site preparation, closure

techniques, dressings and management of problematic

wounds. These decisions require integration of

information from research, clinical expertise, patient

preferences and the availability of resources. For many

decisions there is a shortage of good quality evidence

from research and in this situation we need to learn

from our own clinical experience andthat of others.Sharing experiences by publications such as the EWMA

Journal is one approach, face to face, at conferences,

such as the forthcoming EWMA / GNEAUP in

Granada is another.

The conference will bring together basic scientists,

health service researchers, expert clinicians, educators,

managers and company representatives. Getting together

allows us to get feedback on our work, to identify

potential links for collaboration and is an opportunity

to share what we have been doing in each of our own

areas of interest. So many of the problems we face, be

they in research, practice or education, have already

been identified and solved by others, so why not learn

from them rather than reinventing the wheel. We

increase the efficiency of all our endeavours by learning

from others experience. If wound management is a

science, and I passionately believe that it is, then the

knowledge underpinning it is formed by the firm

foundations provided by the works of others, such as

the pioneering works of Gamgee, Nightengale, and

Winter, to name but a few.

For the science of wound management to realise

improvements in patient outcomes, it needs firm

foundations. We must build upon firm science

not what wed like to hear, but evidence from robust

experiments and observational studies. To ensure thatdecision makers of the future have at their disposal the

sum of all relevant information, we need to commit to

sharing our experiences, whether they be exciting,

encouraging or negative. Without this, data indicating

that therapeutic strategies are not beneficial, are

harmful, or are associated with particular side-effects,

may not get into the public domain. The healthcare

literature contains a number of examples where

treatments have been implemented because the science

seems to fit rather than the clinical evidence, whichshows evidence of no benefit, or even harm (e.g.

debriefing people after trauma compared with no

debriefing results in increased psychiatric morbidity1.

In order to avoid this mistake in wound management,

we need to develop a culture where research results are

published regardless of their findings. A number of

developments makes this easier than ever before:

1. prospective registration of clinical trials on

http://www.clinicaltrials.com,

2. the Database of Individual Patient Experiences(DIPEx) at http://www.dipex.co.uk, and

3. electronic journals such as BioMed Central

(http://www.biomedcentral.com/) where space

limitations do not restrict publication of the results

of studies according to their results.

We all strive for improvements in wound management,

and are seeking to make this a reality by undertaking

research, developing practise, and educating the

clinicians of tomorrow. We humbly remember that any

contribution we make pushing back the boundaries of

understanding in wounds is due in part to work done by

pioneers in surgery, nursing, public health, health

services research, and basic sciences. In the words of Sir

Isaac Newton if I have seen further it is by standing on

the shoulder of giants. We are currently standing on the

shoulders of giants, hopefully one day the same will be

said of our contribution to wound management.

E. Andrea Nelson

1 Suzanna Rose, Jonathan Bisson, Simon Wessely. Psychological debriefingfor preventing post traumatic stress disorder (PTSD) (Cochrane Review).In: The Cochrane Library, Issue 1, 2002. Oxford: Update Software.

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Scientific Article

INTRODUCTIONThe ways in which we evaluate the effects ofhealth care interventions are continually de-veloping. It is now common practice for researchfunders to ask that a systematic review of all the

available high quality studies be undertaken toensure that any proposed investigations build

upon existing evidence. The methods used inthese investigations are also developing, withincreasing integration of patient-based assess-ments as well as clinical results and laboratorydata. Measuring how patients feel about a healthproblem and the treatments used is no longerregarded as soft data i.e. that which is inaccurateand unreliable. The importance of measuring theimpact of ill-health and treatment is not simple,

but, as clinical challenges include care as well ascure, it is increasingly important that our eva-

luations of interventions are informed by patientsviews.

DEFINITIONSJenkinson and McGee1 state that while there is noagreed single definition of Health related qualityof life (HRQoL), the definitions available includegeneral health, cognitive function, mental health,

emotional health, subjective well-being, life sat-isfaction and social support. This is, in part, de-

rived from the World Health Organisations

(WHO) definition of health; Health is a state ofcomplete physical, mental, and social well-beingand not merely absence of disease2 (WHO 1984).Health related quality of life attempts to incorpo-rate both personal health status and social well-being in assessing health.

FROM FOCUSSED TRIALS TOPOPULATION STUDIESAssessing the health of particular populations,such as people with skin conditions, can provide

information on their health profile and their pos-sible health needs. Such information may be usedto determine whether these groups are being wellserved by current health provision, whether addi-

Health Related Quality

of Life Measurementtional services are needed, and at whom theyshould be targeted. This is particularly importantin assessing the burden of illness associated withnon-fatal health conditions where considerablemorbidity is masked by low mortality. Some

HRQoL measures, e.g. the SF-36, have been usedon sufficiently large numbers of people so that the

results are available for the norm values forpopulations according to age and gender. Thisallows comparison to be made between popu-lations under study with age and sex matchedpopulations.

Randomised controlled trials (RCTs) are usedto evaluate the effect of health care interventions,whether they be drugs, devices, surgical treat-ments, or new methods of service delivery, such

as clinic versus home care for leg ulceration. Insome trials, the researchers and clinicians are in-

terested mainly in survival, and the trial is designedto follow-up participants until death. Increasingly,however, the aim of the researchers is to improvethe quality of life as well as the length of survival.This has arisen from the finding that patients mayfind treatments unacceptable, due to side effects,and withdraw from active treatment. In addition,some treatments may not improve survival but

have the potential to improve the quality of life re-maining. Much of the activity in health care pro-

vision is not designed to extend life but to reduce

pain and improve quality of life, e.g. joint replace-ment, cataract removal, and many areas of woundcare.

Finally, the use of HRQoL in trials gives usinformation on the impact of treatment on qual-ity of life, so that if two therapies have similar levelsof effectiveness and cost, but have different effectson quality of life, then this important finding caninform the choice of acceptable interventions.

Jenkinson and McGee1 point out that the in-creased use of HRQoL measures in trials needs to

be balanced by critical appraisal of their use. Guid-ance on their appropriate use in trials can be foundat the end of this article.

E. Andrea NelsonPhD RGN

Research Fellow,

Department of

Health Sciences,

University of York, UK

EWMA Treasurer and

Editor of EWMA Journal.

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ESSENTIAL ASPECTS OFQUALITY OF LIFE MEASURES

Validity

A valid measure is one that measures what it claims tomeasure. Ideally one would be able to compare a HRQoLmeasure with a gold-standard measure, but this is notusually available and therefore one examines the validityindirectly, by referring to face validity, content validity,

criterion validity and construct validity.Face validity refers to whether a measure contains items

that appear appropriate to that which is being measured.It also requires that the items / questions are easily under-stood and not ambiguous.

Content validity refers to the choice of items / ques-tions in the measure. These are generally developed aftersearching the literature, and from in-depth interviews of

the general public or people with health problems. It is im-portant that concerns of import to many people are in-cluded at the expense of rarer concerns, for example if painis commonly reported on interviews of people with leg

ulcers, then a couple of items on this would be included.Weightings are usually applied to items in the measure in

order to give more weight to some items such as I worryabout my ulcer all the time rather than I sometimes worryabout my ulcer.

Construct validity refers to the construction and test-ing of hypotheses associated with the health condition

using the measure. For example, the construct validity ofthe SF-36 has lower scores (worse health) for older peo-ple, and those with illnesses, than for younger people, orthose without illnesses.

Criterion validity refers to the ability of an instrumentto correlate with other measures used to assess the samepeople. The presence of a gold standard is rare in this area

of research. One approach is to record the progress of ahealth condition, e.g. healing of a chronic wound, andrecord the concurrent change in the HRQoL measure.There should be agreement between subjective health re-

ports and the HRQoL measure.

Reliability

Measures should be reliable over time, such that they pro-duce similar results when administered on two or more

occasions, given that the health of the respondent has notchanged. The HRQoL measure, usually a self-administered

questionnaire, should be so simple to understand on ini-tial presentation that there is no learning effect thus avoid-ing a potential change in response unrelated to changes inhealth condition. This is called test-retest reliability.

The internal reliability (also referred to as internal con-sistency reliability) is commonly measured using theCronbach alpha statistic (for items with more than two

available responses) or the Kuder-Richardson (KR-20)test for items with only two available responses3. TheCronbach alpha is a measure of correlation above thatwhich would be expected by chance. The principle behindthese tests is that there should be a high correlation be-tween the results within a questionnaire if all the questionsare investigating one area of interest. High values ofCronbach alpha (0.9 - 0.999) may indicate high internalconsistency, but might also mean that the same question

is being asked more than once.

Sensitivity

A sensitive measure is able to detect change in the targetcondition. This is also called responsiveness. There are anumber of statistical approaches to determining the re-sponsiveness of a measure. These measure, for example, thesize of the difference detected by a measure in relation to

the variability of the measure. Jenkinson and McGee1

of-fer a critique of the methods used. Generic measures ofHRQoL may not be able to detect changes in health sta-tus in older people associated with, for example, the heal-

ing on a wound. This may be because the global assessmentof health is relatively unaffected by one discrete health

condition. In this situation, therefore, it may be necessaryto use both a generic HRQoL measure, to capture changesin overall health, and a condition-specific one, to chartchanges in quality of life related to one specific condition.

Generic measuresThese measures can be used across a wide range of illnesspopulations as well as healthy populations. Two of thesemeasures have been regularly used in wound care research The Nottingham Health Profile4,5 (Franks et al 1999,Hunt et al 1985) and the SF-366,7.

The Nottingham Health Profile, a short, self-admini-

stered questionnaire, has been used in studies of the gen-eral population, in leg ulcer trials, and in many otherchronic health problems5. The tool is intended to meas-ure perceptions of ill health on six dimensions; pain, physi-

cal mobility, emotional reactions, sleep disturbance, socialisolation and energy. Jenkinson and McGee1 report thatthe measure is good at identifying people with chronic ill-nesses and distinguishing between different conditions. Ithas also been translated and therefore can be used in in-ternational / trans-cultural trials.

The tool was designed to assess the severe end of ill

health and therefore some people measure zero when theirhealth is affected a small amount. This floor effect meansthat the tool may not be able to detect changes in healthstatus at the less severe end of ill health8 1987.

The SF-36 was developed during the RAND cor-poration study of the relationship between Health Insur-ance provision and medical outcomes7. This tool had to

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be relevant and easily understood by the general popula-tion as well as by patient groups. The SF-36 contains eightdimensions and a single question referring to the per-ceived change in health condition over the past year. Thedimensions are: Physical functioning Role limitation due to physical problems Role limitation due to emotional problems Social functioning Mental health Energy/vitality Pain General health perception

More recently, a 12-item questionnaire has been devel-oped, SF-129 that produces scores for the same eight di-mensions. Comparison between the SF-12 and SF-36

show considerable accuracy, so the SF-12 may be usefulin studies where a short, reliable and valid generic healthmeasure is required.

Disease specific measures

These quality of life measures are designed specifically to

target a particular patient group, such as people with legulcers10. There appears to be a real gap in the assessmentof the impact of acute and chronic wounds on quality oflife, and reliable tools are badly needed. The developmentof a disease-specific HRQoL measure with rigorous meas-

urement properties, outlined above, is time consuming,but evaluation of health technologies and methods of de-livering care are in danger of ignoring the voice of patientsif we cannot reliably collect this information.

USING REPORTS OF HRQoLIt is clear that quality of life measures are becoming morewidely used and will be included in more trials and, con-sequently, will appear more in the research literature. Theinclusion of these reports will not, on their own, lead to

useful information for health care providers and clinicians;the information derived from the measure must also bemeaningful, as well as valid and reliable. Fitzpatrick et al11

undertook a systematic review of the literature on HRQoLmeasures and have suggested eight requirements for judg-ing the appropriateness of outcome measures in clinicaltrials. These include:

1. Is the content of the measure appropriate tothe questions that the clinical trial is intendedto address?

2. Does the instrument produce reliable results(results that can be reproduced and are internallyconsistent)?

3. Is the measure valid (does it measure what it claimsto measure)?

4. Is the measure responsive (does it measure changesover time that matter to patients)?

5. How precise are the scores on the measure (how ableis the measure to detect differences in health)?

6. How interpretable are the scores on the measure?7. Is the measure acceptable to patients (is to too long,

potentially distressing)?

8. How feasible is the measure (is it easy to administerand process)?

Jenkinson and McGee1 suggest that papers that do notattempt to address these issues must be regarded as poten-tially flawed. This approach to demanding clearer report-ing of the methods in trials mirrors the demand for clearerreporting of systematic reviews12 (QUOROM) and ran-

domised controlled trials (CONSORT)13

.

CONCLUSIONThe funds available to purchase health care are always

likely to be limited and, therefore, the pressure on gettingthe best health for the population within a limited budget

will increase. Evaluating the quality of life of populations,as well as the longevity, allows us to compare outcomesacross health conditions and between competing inter-ventions. Valid and reliable tools for measuring condition-specific quality of life are urgently needed in wound man-

agement. References

1. Jenkinson C, McGee H (1998) Health status measurement:a brief but critical introduction. Abingdon, Radcliffe Medical Press Ltd.

2. World Health Organization (1984) The constitution of the World HealthOrganization. WHO Chronicle. 1:13.

3. Cronbach LJ (1951), Coefficient alpha and the internal structure of tests.Psychometrika. 16:297-334.

4. Franks PJ, Bosanquet N, Brown D, Straub J, Harper DR, and Ruckley CV.Perceived health in a randomised trial of treatment for chronic venous ulceration.European Journal of Vascular and Endovascular Surgery 1999; 17(2): 155-9.

5. Hunt S, McEwen J, Mckenna S (1985) Measuring health status:a new tool for clinicians and epidemiologists.Journal of the Royal College of General Practitioners. 35: 185-8.

6. Brereton L, Morrell J, Collinsk, Walters S, Peters J, Booker. Patients tolerance of

leg ulcer treatment. J. Br J Community Health Nurs 1997;2(9):427-30

7. Ware J, Sherbourne C (1992) The MOS 36 item short-form health survey 1:conceptual framework and item selection. Medical care.30. 473-83.

8. Kind P, Carr-Hill R (1987) The Nottingham Profile: a useful tool for epidemiologists?Social Science and Medicine. 27. 1411-14.

9. Ware J, Kosinski M, Keller SD (1995) A 12 item short-form health survey. SF-12:scale construction and preliminary test of reliability and validity. Medicalk care.34:220-33.

10. Hyland ME, Ley BA, Thomson B. Quality of life in leg ulcer patients:questionnaire and preliminary findings. Journal of Wound Care 1994; 3(6):103.

11. Fitzpatrick R, Davey C, Buxton M, Jones D. 1997. Evaluating patient basedoutcome measures for use in clinical trials. Health Technology Assessment.

12. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF, and QUOROMGroup. Improving the quality of reports of meta-analyses of randomised controlledtrials: the QUOROM statement. Lancet 1999; 354(9193): 1-10.

13. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz

KF, Simel D, Stroup DF. Improving the quality of reporting of randomised controlledtrials. The CONSORT statement. JAMA 1996; 276(8): 637-9.

Scientific Article

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Clinical Article

ABSTRACTManagement guidelines have identified compres-sion therapy as the cornerstone in the treatment

of venous leg ulcers. An international panel hasrecently designed a practical and easy-to-use man-agement pathway (management algorithm) focus-

ing on the role of compression therapy in venousleg ulcer therapy. The panels objective was to pro-

vide physicians, nurses and other healthcare pro-fessionals with a useful tool in the managementof venous leg ulcers. It is hoped that this practi-cal and straightforward approach will ensure thatthe findings are widely disseminated and imple-mented. The algorithm is based on a comprehen-

sive, qualitative review of the literature and, wheredata are lacking, consensus from a panel of inter-national leg ulcer specialists based on their clini-cal experience.

INTRODUCTIONThe appropriate management of venous leg ulcersis a continuing challenge to healthcare profession-als, despite the publication of numerous usefulmanagement guidelines and systematic reviews.1-8

Approximately 1-2% of the general population

suffer from a poorly healing ulcer of the lowerextremity in their lifetime.9 More effective man-agement strategies are required which are based onthe results of randomised, controlled trials, im-proved organisational structures and multi-disci-

plinary co-operation. In addition, it is vital thatany evidence-based recommendations are widely

disseminated and easily implemented to maxim-ise benefits to patients.

Compression therapy remains the cornerstone oftherapy in venous leg ulcers10 and this documentprovides an up-to-date, qualitative overview of the

literature and expert consensus on the use of com-pression therapy in the treatment of venous leg

ulcers. This work was carried out by a distin-guished international, multi-disciplinary groupand aims to continue and expand on the excellentwork reported in previous guidelines, in particu-lar the RCN and SIGN guidelines.1,2

The main outcome of this co-operation was toproduce a management pathway (managementalgorithm) designed for easy implementation byphysicians, nurses and other healthcare profession-

als. The algorithm is based on the best quality datareviewed in the current literature, and where this

was not available, on consensus opinion fromexperts in the field. These findings have alreadyreceived additional input from other healthcareprofessionals at a recent international symposium.It is hoped that this algorithm will be a useful tool

in improving the management of venous legulcers.

METHODSA literature search using MEDLINE and

EMBASE was carried out from 1966 and from1974 respectively using the keywords: compres-

The use of

Compression Therapy

in the Treatment ofVenous Leg Ulcers:a recommended Management Pathway

Michael Stacey1

Vincent Falanga2

William Marston3

Christine Moffatt4

Tania Phillips5

R Gary Sibbald6

Wolfgang Vanscheidt7

and

Christina Lindholm8

for the International Leg

Ulcer Advisory Board.*

1University of Western Australia, Fremantle, Australia;2Department of Dermatology and Biochemistry, Boston University, MA, USA;3University of North Carolina, Chapel Hill, NC, USA;4Thames Valley University, London, UK;5Boston University School of Medicine, Boston, MT, USA;6University of Toronto, ON, Canada;7Universitts-Hautklinik, Freiburg, Germany;8Karolinska Hospital, Stockholm, Sweden.

These recommendations were compiled by an

international expert panel, with complete editorial

freedom. All panel members have collaborated

on this project without remuneration. A small,unrestricted educational grant was provided by

Smith & Nephew Medical Ltd and used by the

panel for co-ordination and communication.

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sion therapy/treatment, venous leg ulcers, clinical paper/article/trial or review, and selecting human, priority jour-nals. Relevant journals and conference proceedings fromthe past five years were manually searched and reviewedfor relevance. Existing guidelines such as the RCN andSIGN guidelines provided valuable information. The panelmembers also contributed additional papers. An experi-

enced clinical researcher in the field provided a largenumber of publications in non-English language journals.Nearly 150 papers were selected for detailed review and

were graded using a hierarchy of evidence, tool-based onan example by Guyatt et al. (Figure 1).11 These papers

provided the evidence base for the algorithm. A full list ofreferences reviewed is available on request.

The panel drafted a management algorithm that was dis-cussed at a meeting in September 2001, and the algorithmwas subsequently presented for comment at an interna-

tional symposium during Innovations in Wound CareWeek in Cardiff UK.

Definitions

There remains some debate on the definitions of certainaspects of compression therapy. For the purpose of design-

ing the management algorithm, the panel agreed on anumber of terms (Figure 2). Elastic compression (long-

stretch) bandages exert high compression during rest andexercise whereas inelastic (short-stretch) bandages producepassive compression mainly when the calf muscle con-

tracts, increases in volume and creates pressure against thebandage. At rest, inelastic compression bandages exertpressure dependent on the tension used during application.

MANAGEMENT ALGORITHMThe panel designed a management algorithm based on areview of the available literature and expert consensus

(Figure 3). In order to ensure ease of use and effectiveness,the algorithm has been kept as simple and straightforward

as possible. The algorithm can be broken down into fourstages: Assessment, Diagnosis, Recommendations for treat-

ment, and Outcomes.

Assessment

Accurate assessment is necessary to ensure the correct ae-tiology of the ulceration and to exclude those patients witharterial disease for whom compression is dangerous. Thereare a number of non-invasive methods used to confirmvenous disease when a patient presents with suspectedvenous disease. Methods of assessment include: Hand-held, continuous-wave Doppler ultrasound

measurement of ankle brachial pressure index

(ABPI). This is regarded as the most reliable wayof detecting arterial insufficiency,12 however, in

patients with diabetes Doppler waveform analysis

and toe pressure measurements are the more reliablemethods. Duplex ultrasonography, that measures blood flow

velocity through a vessel, is the primary method ofidentifying venous obstruction or abnormal venousreflux.13

A number of plethysmographic methods, includingair and photo plethysmography, which may be usedto assess venous function.

A number of other investigations should take place to ex-

clude other disorders such as rheumatoid arthritis, diabe-tes, renal failure, anaemia, tumours and autoimmune dis-orders.

Figure 1: Grade Type of study

1 Systematic review, meta-analysis, randomised controlled trial

2 Well-designed cohort or case-control studies

3 Well-designed non-experimental descriptive studies (compara-tive studies, correlation studies, case control studies)

4 Evidence from expert committee reports, opinions and/or clini-

cal experience of respected authorities.Figure 1. Hierarchy of evidence.11

Figure 2: Definitions

Sustained compressionAny bandaging system providing sustained compression for at leastone week(NB. More frequent dressing changes may be needed if the woundis large and/or heavily exuding)

Multi-layered (elastic) compression

Currently presented as 4-layer high compression bandagingproviding sustained, graduated compression (including bandages>50% extension and exerting pressure at rest).(N.B. There are substantial differences in systems depending onbandage characteristics).

Multi-layered (inelastic) compressionMulti-layer inelastic bandaging (

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Diagnosis

Following assessment, the patient with a leg ulcer can beassigned to one of five groups. In brief, patients with a

venous leg ulcer require compression therapy, those withan arterial leg ulcer or with a significant arterial compo-

nent require referral to a vascular specialist. Patients withmixed arterial and venous ulcers require reduced compres-sion therapy with referral to a vascular specialist, particu-larly if there is pain at rest. Patients with ulcers from othersources require disease-specific treatment and compressiontherapy for oedema control.

There remains some debate on the definition of arterialinsufficiency by ABPI and the scope of the mixed arterial/venous ulcer groups was agreed based on the panels clini-

cal experience rather than demonstrated in the literature.

Recommendations for treatment

This algorithm focuses on the appropriate use of compres-sion therapy in the treatment of venous leg ulcers. It iswidely accepted that sustained compression provides themainstay of treatment in venous leg ulcers. This should besupported with adjunctive medical and surgical therapy,appropriate dressings and patient education.

Sustained compression is provided by multi-layer elasticor inelastic bandage systems. There is now considerable

evidence to show that this form of sustained high compres-sion improves ulcer healing and provides quality of life and

cost benefits. Three systematic reviews have shown thatcompression therapy does increase the healing rate of ve-nous leg ulcers.3,6,14 Multi-layer high compression band-aging improves healing of venous leg ulcers when com-pared with single layer, low compression bandaging al-though there is little reliable evidence, to date, of large,randomised, controlled trials which directly compare4-layer compression to 3-layer or 2-layer bandaging.3,15

To date, there is insufficient data to suggest a differencein benefit in terms of ulcer healing between elastic and in-

elastic compression.

These multi-layer bandage systems are complemented byreduced compression systems (15-25 mmHg) for thosepatients who cannot tolerate high compression systems,and compression stockings. Intermittent pneumatic com-pression (IPC) is a useful adjunct to multi-layer compres-sion and has been shown to improve ulcer healing rateswhen used with multi-layer compression.3

Figure 3:The use of Compression Therapy in the treatment of Venous Leg Ulcers:a recommended management pathway

Clinical Article

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Clinical Article

Medical and surgical treatment: There are a number of ad-junctive medical therapies that are currently in use with-out unequivocal support in the literature. Discussion ofthese therapies lies beyond the scope of this paper. Thereis also increasing realisation that chronic wounds, such asvenous ulcers, benefit from an overall approach aimed atoptimising the wound bed. This approach, termed woundbed preparation, includes a number of aspects critical to

wound care, such as elimination of excessive exudate andbacterial burden, debridement and elimination of necrotic

tissue, angiogenesis and the formation of a wound matrixthat promotes re-epithelialisation.

There is also emerging evidence that skin substitutes maybe beneficial in the treatment of hard to heal venous legulcers (especially in those with duration >1 year) when

used in conjunction with multi-layer compression band-aging.16,17 Other biological agents, such as growth factorsand protease inhibitors are currently being evaluated fortheir efficacy in the management of venous leg ulcers.

Many patients with leg ulcers suffer pain that can adversely

affect quality of life and may influence speed of healing.Reduced compression should be used until pain andoedema resolves and then high compression bandaging canbe introduced. In most cases, appropriate dressings or oralanalgesics can effectively manage pain although skin graft-

ing may be required in cases of intractable pain.

Appropriate dressing selection: Patients with leg ulcers areprone to contact sensitivity particularly from wool alco-hols, topical neomycin, framycetin, cetylstearyl alcoholsand rubber mixes which are present in many dressings,ointments and creams.18 Emphasis should be placed on

allergen avoidance to allow optimal wound healing. How-ever this remains a difficult management issue in individualpatients.

Education: Factors that encourage ulcer healing, such asimproved nutritional status, appropriate bandage use andmobility, are dependent on patient involvement. Educa-tion to improve patient understanding of the conditionwill aid compliance to therapy.

Mobile and immobile patients: Reduced mobility and re-

duced ankle function, as well as other factors such as ul-cer size and duration, have been shown to independentlyaffect healing rates.19,20 As inelastic bandages lose pressurewhen leg oedema is reduced, multi-layer (elastic) compres-

sion is recommended as first-line therapy for immobilepatients with venous leg ulcers. However, these recommen-dations are based on expert opinion rather than beingdemonstrated conclusively in the literature at this stage.

Elastic stockings can be used as second-line therapy inmobile patients, particularly those that are young andworking, who are unable or unwilling to tolerate multi-layered compression.

Reasons for referral: Patients should be referred for special-ist opinion in a number of cases (see Reasons for referralbox). If a patient is unable to tolerate compression a spe-

cialist may be able to identify the reason for the problem,and then take the patient through a process to temporar-

ily reduce compression, control pain, educate patient in theimportance of sustained compression, and then re-instatetreatment.

During acute infection patients with venous leg ulcers mayrequire reduced compression for a period of time. The level

of compression should be tailored according to symptomssuch as the level of pain.

Outcomes

The panel has recommended a definition of failure to healas no reduction in ulcer size in 1 month. Patients with

ulcers 10 cm2 are likely to take a long

time to heal and skin grafting may be required.

Following healing of the ulcer, steps must be taken tominimise the risk of recurrence by using compressionhosiery and maintaining education and support to thepatient. Control of oedema by elevation and use of com-pression hosiery for life may be required. Compression

hosiery should be applied at the highest level of pressuresubject to patient compliance and dexterity.

CONCLUSIONSThis new algorithm, based on a comprehensive review ofthe literature and expert consensus, confirms the role ofsustained compression (elastic and inelastic) as first-linetherapy for venous leg ulcers.

Reduced compression and compression hosiery are useful

alternatives in those patients with additional arterial dis-ease or who cannot tolerate multi-layer bandaging. Inter-mittent pneumatic compression is a valuable adjunctivetherapy in the treatment of venous leg ulcers although

there is a need for further evidence-based findings on thesetechniques.

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In addition, there is a need for further randomised, con-trolled trials on the other medical and surgical therapiesto be used in conjunction with compression therapy.

It is hoped that this algorithm provides a useful workingtool for primary care physicians and nurse practitionersto provide appropriate care based on the latest findingsin the literature.

References

1. Cullum N, Luker K, McInnes E, Nelson A, Noakes H. Clinical Practice Guidelines:The Management of Patients with Venous Leg Ulcers. RCN Institute, London, 1998.

2. The Care of Patients with Chronic Leg Ulcer: a national clinical guideline.The Scottish Intercollegiate Guidelines Network (SIGN Publication No. 26, 1998).

3. Fletcher A, Cullum N, Sheldon T. A systematic review of compression treatmentfor venous leg ulcers. BMJ 1997; 315: 576-80.

4. Consensus Paper on Venous Leg Ulcers: the Alexander House Group. Phlebology1992;7:48-58.

5. Kunimoto B, Cooling M, Gulliver W, Houghton P, Orsted H, Sibbald RG.Best Practices for the Prevention and Treatment of Venous Leg Ulcers.

Ostomy/Wound Management 2001;47 (2): 34-50.6. Palfreyman SJ, Lochiel R, Michaels JA. A systematic review of compression

therapy for venous leg ulcers. Vascular Medicine 1998; 3: 301-313.

7. Nelson EA, Ruckley CV, Dale J, Morison M. The management of leg ulcers.Journal of Wound Care 1996; 5 (2): 73-76.

8. Agus GB, Allegra C, Arpaia G et al. Guidelines on compression therapy.Acta Phlebologica 2001; 2 (Suppl 1): 1-24.

9. Callam MJ, Ruckley CV, Harper DR, Dale JJ. Chronic ulceration of the leg:extent of the problem and provision of care. BMJ 1985; 290;1855-1856.

10. Ramelet A-A. Compression and leg ulcers. In: Compression therapy.Gardon-Mollard C, Ramelet A-A (eds). Masson: Paris, 1999: 126-131.

11. Guyatt GH, Sackett DL, Sinclair JC. Users guides to the medical literature. IX. Amethod for grading healthcare recommendations. JAMA 1995; 274; 1800-1804.

12. Moffat CJ, OHare L. Ankle pulses are not sufficient to detect impaired arterialcirculation in patients with leg ulcers. Journal of Wound Care 1995; 4 (3): 134-138.

13. Nicolaides AN. Investigation of chronic venous insufficiency: a consensus statement.

Circulation 2000;102:126-163.

14. Cullum N, Nelson EA, Fletcher AW, Sheldon TA et al. Compression forvenous leg ulcers (Cochrane Review), The Cochrane Library, Issue 2, 2001.

15. Nelson EA, Harper DR, Ruckley CV et al. A randomised trial of single-layer andmulti-layer bandages in the treatment of chronic venous ulceration. Phlebology1995; (Suppl 1): 915-916.

16. Falanga V, Sabolinski M. A bilayered living skin construct (APLIGRAF) acceleratescomplete closure of hard-to-heal venous ulcers. Wound Repair Regen 1999Jul-Aug;7(4):201-7.

17. Harding K. A prospective, multicenter, randomized, controlled clinical investigation ofDermagraft(r) in patients with venous leg ulcers, a feasibility study. Oral presentationat World Wide Wounds Conference, Melbourne, Australia, 2000.

18. Wilson CL, Cameron J, Powell SM et al. High incidence of contact dermatitisin leg ulcer patients implications for management.Clinical and Experimental Dermatology 1991; 16: 250-3.

19. Franks PJ, Moffatt CJ, Connelly M et al. Factors associated with healing leg

ulceration with high compression. Age Ageing 1995; 24: 407-410.20. Margolis DJ, Berlin JA, Strom BL. Risk factors associated with the failure of

a venous leg ulcer to heal. Arch Dermatol 1999; 135: 920-926.

* Members of the Leg Ulcer Advisory BoardProfessor Claudio Allegra, University of Rome, Rome, Italy

Dr Vincent Falanga, Boston University, Boston, MA, USA

Dr Mieke Fleur, U.Z. K.U. Leuven, Belgium

Professor Keith Harding, University of Wales College of Medicine, Cardiff, UK

Professor Michael Jnger, Ernst-Moritz-Arndt-University, Greifswald, Germany

Associate Professor Christina Lindholm, Uppsala University, Sweden

Dr William Marston, University of North Carolina, Chapel Hill, NC, USA

Dr Sylvie Meaume, Charles Foix Hospital, Paris, France

Professor Christine Moffatt, Thames Valley University, London, UK

Professor HAM Neuman, University of Maastricht, Maastricht, The Netherlands

Professor Hugo Partsch, University of Vienna, Vienna, Austria

Dr Tania Phillips, Boston University School of Medicine, Boston, MT, USA

Professor Vaughan Ruckley, Royal Infirmary of Edinburgh, Edinburgh, UK

Dr R Gary Sibbald, University of Toronto, ON, Canada

Dr Michael Stacey, University of Western Australia, Fremantle, Australia

Mr Joan-Enric Torra I Bou, Hospital de Terrassa, Barcelona, Spain

Professor Wolfgang Vanscheidt, Universitats-Hautklinik, Freiburg, Germany

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Clinical Article

SUMMARYIn Finland the post of Tissue Viability Nurse(TVN) is unspecified. Despite this, in hospitalsand health care centres, there are nursing profes-

sionals working who are responsible for the devel-opment of wound care practice. These nurses arecalled TVNs. The aim of this study was to de-scribe the professional role, as well as the compe-

tence of TVNs in Finland. The data of the studywas collected in Spring 2000 by survey. The ques-

tionnaires included structured and open-endedquestions1. The open-ended questions were ana-lysed by content analysis2. Statistically data wasinspected by SPSS 10.0. The TVNs were pre-dominantly specialised nurses, with considerable

working experience (mean 16.5 years), but thetime in the post of TVN was not that long. Forover half of the TVNs it was under 6 years. Therole of the TVN was described in four categories:general, special, independent sphere of action, andco-operation. Accordingly, the study of the roleof TVNs included the role of Clinical Nurse Spe-

cialist (CNS)3.It was found that the role of the clinical prac-

titioner was dominating while the role of researchhad a minor part. The professional education for

TVNs needs to be developed so that the theoryand clinical practice of wound care can be inte-grated.

During the past five years wound-care has becamean important issue in Finnish health care. Onereason for this is that modern wound-care prod-

ucts are available in all parts of the country. An-other reason is that the number of wound patientshas increased, especially in primary health care. Atthe same time, in nursing, there has been a debate

on the role and competencies of Clinical NurseSpecialists, who are working, for example, amongdiabetes, asthma and rheumatoid arthritis pa-tients5. Their role is defined. Also the need for

The Professional Roleand Competence of

Tissue Viability Nursesin Finland

TVNs has been recognised and in many hospitalsand health care centres there are nurses workingas professionals who are responsible for the devel-opment of wound care. Despite this, the profes-

sional competence, role, duties and responsibili-ties of TVN are still unofficial and undefined. Theaim of this study was to describe the professionalcompetence and role of TVNs in Finland. The

principal for the study was the Finnish WoundCare Association, which, in co-operation with

Mikkeli and Oulu Polytechnics, has developedspecialist education in Wound Management inFinland6. The part time courses in Wound Man-agement for registered nurses have been imple-mented since autumn 1999. The courses last one

year and incorporate 800 hrs of student work.

The survey of TVNs was implemented in Spring2000. The purpose of the study was to describe theworking history, educational background, role andpreconditions of those nursing professionals whoare working as TVNs in Finland.

The research questions were: What is the educational background and

working history of nursing professionals who

are working as Tissue Viability Nurses? What does a TVNs work involve? What kind of support do TVNs get from

their superiors? What kind of preconditions do TVNs expect

from their work to be able to further developtheir professional competence and skills?

The data was collected by survey with structuredand open-ended questions. The structured ques-tions considered the TVNs age, sex, workplace,

basic education, nursing speciality, work experi-ence and time in the post of TVN in years. Theopen-ended questions included questions on theTVNs role and the improvements that they have

Salla SeppnenRN, MNSc

Doctoral Candidate

Senior Lecturer at

Oulu Polytechnic,

Oulainen Department of

Nursing. Responsible for

Specialisation studies of

Nursing in the level of

advanced practice.Co-ordinator of special-

isation study branches

course of Wound Manage-

ment, 20 cu (800 hrs).

New chairperson of Finnish

Wound Care Society.

Correspondence to:Salla Seppnen

Oulu Polytechnic

Oulainen Department

of Nursing

P.BOX. 12

FIN-86301 Oulainen

FINLANDTel: + 358 84793 438

Fax: + 358 8 4793 432

[email protected]

Papers presented at

EWMA Dublin 2001

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made during their TVN career. The open-ended questions considered the received andexpected support from their superiors. Thequestions were also formulated to include thereferences used by the TVNs and the expecta-tions for further education.

The coded questionnaires were sent to admin-istrative nurses in all university and central

hospitals, five district hospitals and 31 wardsor home care units in primary health care in

Finland. The administrative nurses were askedto give the questionnaires to the TVN(s) intheir organisation. This way the nursing pro-fessionals who were nominated as TVNs wererecognised for the study.

After three weeks, those organisations that

had not returned the survey were sent a repeatsurvey. In total 123 questionnaires were sent,of which 84 were returned. The data was sta-

qualified for many years, the average being 16.5 years. Thetime period in the post of TVN was less than six years inover half the cases.

Some TVNs reported that they had had further woundcare education mainly from one or two day seminars,which were arranged by the Finnish Wound Care Associa-tion. In addition, the manufacturers of wound care prod-

ucts were reported to be providers of education. Five of theTVNs had studied Wound Management at polytechniclevel.

One third of TVNs reported that they had not beenformally appointed the post of TVN. To quote an exam-ple:

I just got the tasks because of my own interest.The nomination for the post of TVN was in most cases

through a ward sister. In ten cases the nominator was anadministrative nurse or medical doctor. In five cases thetasks of TVN were included as a part of infection control.

Figure 1:Send and received questionnaires

Figure 2: General sphere of action described byTissue Viability Nurses (n= 337)

tistically analysed by SPSS 10.0 for Windows. The open-

ended questions were analysed by content analysis. Themain categories were formulated according to the research

questions and the sub-categories were developed induc-tively from the data1,2. All categories were coded as a vari-able in SPSS. The total number of variables was 115. Sta-tistically data was inspected with frequencies, percentagesand means

Figure 1 shows the numbers of sent and received question-naires from different provinces of Finland.

The study covered TVNs in the whole of Finland, and68% of questionnaires sent out were completed and re-turned. The results of the study will be presented accord-

ing the research questions.

EDUCATIONAL BACKGROUND AND

WORKING HISTORY OF TVNMost of the TVNs were female (81 of 84). Only three ofthem were male. The average age of a TVN was 43 yearswith the youngest being 26 years old and the oldest 58years old. The educational background of TVNs showedthat 40 were Specialised Nurses and those mainly havingspecialised in surgical or surgical-medical nursing. Twenty-

four TVNs were registered nurses, seven were public healthnurses and twelve were practical nurses. Only one of theTVNs had university education, an MNSc. The TVNsworked in both specialised and primary sectors with 46

being specialised (46) and 38 in primary health care. Inspecialised care most of the TVNs (48) worked in surgi-cal departments. Two TVNs were working in paediatricunits and two in intensive care units. Most TVNs had been

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Sub-category Number Example from the dataof mentions

Treatment of 36 I do the treatments of the woundswounds ... the mechanical debridement of wounds

... also the practical skills are very important. I have my own wound patients,all of the time.

Educating the 25 I supervise other nurses in the treatment of the woundsnursing staff It is my responsibility to mentor and educate the new nurses in wound management

Special knowledge 19 I do have an expertise in local treatment of woundsin wound I select the right wound-care product and how often it is changedmanagement

Educating 18 Patient education in dressings, compression treatments etc

a patient Supervise patients and relatives to care for the wounds themselvesand relatives

Selecting wound- 17 I take care that the wound-care products in our ward are appropriatecare products I select and decide which wound-care products are used in our unit

Getting knowledge 17 I search for new information on wound-care and then inform my colleaguesand informing other

Developing personal 8 I have to keep my knowledge up-to-date by studying all of the timeprofessional skills I have to be aware of all new products in wound-care

Research 6 I plan the case studies for the new wound-care products and do the follow upthat is needed

Lecturing and 6 I attend and give lectures on wound management in the nursing schooleducating outside and on study dayshome organisation I have educated staff in the home care unit and home help services in wound care

Recognising the 3 I identify the at risk patients, for example in diabetics foot problems or with leg ulcerrisk patients patients, and get them to meet the doctor

Table 1: The subcategories describing the Tissue Viability Nurses special sphere of action(n= number of classified mentions 155)

ROLE OF TVNThe role of the TVN was described in four categories:1. General, 2. Special, 3. Independent sphere of action, and4. Co-operation.

1. The general sphere of action included eight catego-ries to describe the work of a TVN. (Figure 2)

The work of TVNs was mostly very practical and in-

cluded treatment of wounds and decision-making onwound care products. The TVNs stressed their

wound assessment skills. Also education of the nurs-ing staff was an important area in the TVNs work.Some of the TVNs had participated in organising re-gional network education for the treatment of leg ul-cers and had lectured in nursing schools. The role ofpatient education was not as dominant as expected.

It was merely mentioned and not described in detail.Research and developmental activities were mainlydescribed as being pilot case studies of wound-careproducts. Only one TVN described having partici-

pated in a multi-scientific research project on woundmanagement. Consulting was done internally and

outside the TVNs own organisations and TVNs re-ported an increased amount of telephone consulting.

2. The special sphere of TVNs was described through10 sub-categories, which are listed in table 1.

The special sphere included treatment of wounds,educating the staff, and being a consultant with spe-cial knowledge of wound management, as well as theeducating of patients and their relatives. However,professional development and research were men-tioned by just a few TVNs.

3. The independent sphere was divided into sixsubcategories including decision-making on the

wound-care products, educating the patients, edu-cating the patients relatives, educating the nursing

staff, developing wound-care instructions, and pa-tient education material.

4. TVNs co-operated a great deal with other healthprofessionals, especially with doctors and nurses inthe clinic or ward where they worked. Also, co-op-

eration with other TVNs and nurses in home careunits was reported. The main form of co-operationwas consulting and advising on treatment of woundsand selection of wound-care products.

The TVNs described many improvements that they had

made. On a general level, they reported that the attitudetoward wound management has become more positive inwards and clinics where they work. They also describedvery concrete and practical improvements, which had beenmade, like changes in wound treatment routines, better

Clinical Article

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Figure 3: Reported improvements by Tissue Viability Nursesdescribed by categories in percentages (n= 145)

asepsis in wound management, shared principals of woundmanagement and written instructions for nurses on howto manage wounds. The new documentation on wound-care included wound assessment charts, nursing documen-tation and tracing of wounds. Figure 3 shows the reportedimprovements of TVNs.

RECEIVED AND EXPECTED SUPPORT OF TVNMost of the TVNs reported that they had received support

from their superiors. Approval from superiors and organi-sations in addition to extra working time for the develop-ment of wound management were seen as the most im-portant factors. Also, managers were reported as beingsupportive in allowing time to participate in seminars and

conferences. However, many TVNs reported that they felttheir role was very unspecified and they wished that therole and their responsibilities were given more recognition.Also, some of the TVNs wished for more working time forjust wound management. Ten of the TVNs reported thatthey wished that their role and responsibilities could bemore clearly defined.

TVNs reported that they used references from the nationalmulti-professional journal Haava (Wound), leaflets andmaterial produced by product manufacturers, and basic

nursing study books. Only nine of the TVNs reported thatthey read international professional journals and publica-tions on wound-care. All TVNs wished for further edu-cation with seminars and study visits mentioned most fre-quently. Specialist education was reported as being ex-

pected in the future.

DISCUSSION AND CONCLUSIONSThe study described the role and competence of TVNs inFinland. It also described the preconditions for the pro-fessional development of TVNs. The study was qualitative,

however, the number of TVNs participating in the studywas not very high and this limited the general conclusionsthat could be made from the results. On the other hand,the study covered TVNs working in specialised and pri-

mary health care across the whole of Finland. TVNs from50 different hospitals and health care centres participatedin the study. This increases the reliability of the study1

The study showed that the competence of TVNs variesconsiderably. Educational background was very varied andfew TVN had formal qualifications in wound-care. Ac-cording to the study, a Finnish TVN has the role of Clini-cal Nurse Specialist including clinical practice, education,

consulting, research and administration3,4. The role ofclinical practice was dominant, but also the roles of edu-

cator and consultant were very clearly defined in the study.The role of research was minor. One reason for this mightbe that the TVNs had been appointed because of theirclinical experience, rather than any research-based quali-fications.

Based on the results of the study it can be recommendedthat the role and competence of TVNs be defined nation-ally. The educational criteria of TVNs should also be de-fined nationally. If TVNs are aiming to achieve the posi-

tion of CNS (Clinical Nurse Specialist) it is extremelyimportant that the competence and skills required, as well

as the qualifications needed, are defined. Specialised edu-cation combined with solid working experience in wound-care should qualify a TVN. In the United Kingdom, TVNsare normally educated in universities7,8.

In Finland the aim is to educate TVNs in polytechnics

on a post-graduate qualification course for RNs. The firstcourses for TVNs have already been implemented and thefeedback from the students has been very positive.

This was the first survey of TVNs in Finland. Based on theresults of this study, questionnaires for the professional roleand competence of TVNs have been developed. The rep-

etition of the survey enables the following up of the de-velopment of TVNs educational background, nomina-tion, role and preconditions for their work. The question-naires can also be translated into other languages to allow

transnational comparison of the role and competence ofTVNs.

References

1 Polit, D.F. & Hungler, B.P. Nursing Research. Principles and Methods. J.B.LippincottCompany. California. 1995

2 Morse, J.M.& Filed, P.A. Qualitative Research Methods for Health Professionals.Sage Publications. Thousand Oaks. London. 1995

3 Hamric, A. & Spross, J. The Clinical Nurse Specialist in Theory and Practice. W.BSounders Company. Philadelphia 1989.

4 Suominen, T. & Leino-Kilpi, H. Lis asiantuntijuutta hoitotyhn. Sairaanhoitaja1995, 1.35-36.

5 Mkel, T, Kukkurainen, M-L. & Martio, J. Asiantuntijasairaanhoitajan merkitysreumapotilaan hoidossa. Sairaanhoitaja 2000,7.20-22.

6 Seppnen, S. & Iivanainen, A. Haavahoitaja 2000. Suomen haavanhoitoyhdistys ry:n

julkaisuja n:o 1. Painotalo Ykknen, Oulainen

7 Waterlow, J.A regional study days. The role within the educational strategy on theTVN. Journal of Tissue Viability 1998, 8. 9-11.

8 Hunt, J.A. A Specialist Nurse: an Identified Professional Role or a Personal Agenda?Journal of ADVANCED Nursing 1999, 30, 3. 704-712.

Clinical Article

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INTRODUCTIONThis review includes advances in the topic of fun-

gating wound management, and their status interms of evidence-based practice. They were

accessed from published research findings. Themainstays of the management of fungatingwounds comprise treatment of the underlyingtumour; symptom control; local wound manage-ment and supportive care to the patient and fam-ily. The review is presented in chronological dateorder. Where there was more than one publica-tion on a topic the articles were grouped. Overallthere were a small number of publications, which

were diverse in both content and the discipline ofthe authors.

METHODA key word search was conducted of the follow-ing databases: BioMed CancerLit; BioMedCINAHL; BioMed MEDLINE; and inter-nurse.com; together with a scan of recent woundcare and palliative care journals. This search up-dated a comprehensive literature search under-

taken in August 1999 prior to submission of theauthors PhD thesis on the palliative management

of fungating wounds1. The review does not con-

stitute a systematic review but covers key pub-lished work on this topic since 1991.

CONTENT OF THE REVIEWFungating Wounds

a Research Priority for Palliative Care

A key advance since the retrospective survey con-ducted by Thomas2 is the selection of the topicas a research priority in a Dephi study3. The aim

of the study was to identify ten research prioritiesfor the five major disciplines involved in the

specialty. The topic of fungating wounds reachedthe final round of research priorities identified bythe Palliative Nursing Group and was defined asfollows:

... Compare a selection of treatments and dressings

available for fungating wounds in terms of pre-

venting and controlling odour, patient comfort,

control of bleeding, infection, exudate ...

(Cawley and Webber 1995 Table 5 p. 106) 3

The Management of Malodour

Malodour is a key, distressing feature of advancedmalignant wounds and one that is difficult to con-trol4. A further advance is therefore the literaturereview of the use of metronidazole in the treatmentof malodorous malignant wounds by Hampson5.A number of limitations were identified of currentapproaches to managing odour, the evidence base

for these approaches, together with suggestions for

problem-solving research. For example, Hampson5

found that the data specifying the chemical natureof wound malodours are limited and contradictorywith no cause and effect relationship established.Overall the conclusion was drawn that the justifi-cation for prescribing metronidazole is mainlyanecdotal and therefore further research andchanges in practice are needed5.

The Management of Cutaneous Pain

The management of pain requires identification

of the receptors responsible for the pain so thatappropriate analgesia may be prescribed6. Topicalopiates are increasingly being used to palliate no-ciceptive pain and stinging from damaged and ul-cerated skin. Their effects have been evaluated ina series of uncontrolled case studies7,8,9,10. Clearlythe findings from such case studies need to betreated carefully and not transferred directly to an-other patient with painful lesions before an accu-

rate diagnosis of the individuals problem is made.There is however increasing theoretical under-

standing of opiate sensitive pain11

.This theoreti-cal understanding together with the appropriatetreatment can be transferred, or generalised, fromone patient to another as opposed to a direct trans-

A Review ofAdvances in Fungating

Wound Managementsince EWMA 1991 Papers present ed atEWMA Dublin 2 001

Clinical Article

Patricia GrocottPhD RGN

Research Fellow

Contact Address:

Florence Nightingale School

of Nursing and Midwifery.

Kings College London.

James Clerk Maxwell

Building.57 Waterloo Road. London

SE1 8WA

Tel: 020 7848 3629

Email:

[email protected]

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fer of treatments between patients with no theoreticalexplanation of why this may be appropriate12.

The Application of Honey for Debridement and the

Management of Malodour

Recent laboratory studies demonstrate the antibacterialactivity of honey from the Leptospermum species inAustralia and New Zealand13. The clinical advantagesof using honey for fungating lesions appear to includeclearance of infecting microbial strains, removal of necrotic

tissue and malodour, and an anti-inflammatory actionwith reduced oedema14. At present in the UK honey for

medical purposes is not widely available. However theaccumulating evidence to support its use in the treatmentof haemorrhagic lesions associated with meningococcalsepticaemia and chronic wounds, including fungatingwounds, may change this situation15.

Pilot Study of a Malignant Cutaneous

Wound Staging System (MCW)

The potential advance of this study is a staging system andtherefore a common language for exchanging clinical

information, and for the longitudinal evaluation of

outcomes16

. The study objectives were to determine thecolour, size, hydration and general appearance of malig-nant wounds; the effectiveness of using digital imagery toquantify wound characteristics; and the feasibility of a stag-ing system. The staging system presents a four-stage pro-gression of a malignant lesion with progressive destructionof the basement membrane, including the symptoms thatneed to be managed. The authors concluded that photog-

raphy is an effective method of data collection, outcomemeasurement and longitudinal evaluation. In addition they

considered that although the study was limited (N = 17

wounds, 13 subjects) the characteristics of malignantwounds could be classified into four distinct stages, whichare summarised as follows:

Stage 1: Closed wound/intact skin

Stage 1N: Closed wound/superficially open/hard and fibrous

Stage 2: Open wound/dermis and epidermis involved

Stage 3: Open wound/full thickness skin loss of subcutaneous tissue

Stage 4: Open wound/invasive to deep anatomic structures

(Haisfield-Wolfe and Baxendale-Cox 1999)16

Further testing of this staging system is needed however.For example the findings of the authors study indicate thatall four of the above stages may be found concurrently ona single patient with a rapidly changing, progressive pat-tern of disease, which may limit the utility of the system1.

An Evaluation of the Palliative Management

of Fungating Malignant Wounds, within a

Multiple-Case study Design

This project focused on the palliative management of fun-

gating malignant wounds1. Individual experiences, fromforty-five participants, of living with a fungating wound

were followed in a multiple-case study design. The studyevolved through three principal phases: quasi-experimen-tal design, emergent collaborative design, and emergenttheory-driven evaluation. The radical departure from theinitial research approach was in response to the methodo-logical problems encountered in a study of individuals withuncontrolled disease.

The study had a dual focus. The first was methodological

and the second concerned the generation of explanationsfor dressing performance and the management of fungat-

ing wounds. The methodological aspect included the de-velopment of the TELER system of treatment evalua-tion, as a method of measuring dressing performanceagainst goals of optimal practice in fungating wound man-agement. The system of reasoning was developed as ananalytic strategy for abstracting general issues from indi-vidual case study data to construct explanations. The lat-ter were generalised beyond the individual cases with the

use of theory.

Two forms of explanation for fungating wound manage-

ment were constructed. These include explanations of theindividual experiences of living with a fungating woundand knowledge of the elements of fungating wound man-agement. The impact on the individual of a fungatingwound was explained in terms of the stigma attached topublic disability and a general revulsion in society foruncontrolled body fluids. A pivotal relationship emergedbetween exudate and the other wound management prob-lems, including the psychosocial aspects. A final critical

explanation was developed for the qualification of thecurrently accepted moist wound healing theory to explain

the phenomenon of exudate management in fungating,and possibly other exuding chronic wounds.

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Clinical Article

The potential advances from this study are therefore amethodology for those complex situations where the con-trol of variables is not possible but where specific and rig-orous evidence, capable of generalisation, is needed. Inaddition the explanations of dressing performance indicatewhere there are anomalies in dressing performance forexudate management for fungating wounds, particularlythe impact of low moisture vapour loss from current dress-ings on the accumulation of exudate under the dressing.They therefore form a basis for new approaches, includ-

ing product development, for exudate management.

A Topical Palliative Treatment for Skin Metastases

from Breast Cancer

Miltefosine (ASTA Medica) is a palliative, topical cytostatictreatment for skin metastases from breast cancer, currentlyundergoing clinical trials. Terwogt et al17, for example,conducted a phase II trial of topically applied miltefosinesolution to patients with breast cancer and skin metastases.Thirty-three patients entered the trial and were evaluatedover 8 weeks. A response rate of 43% for thirty evaluablepatients of which 23% was complete and 20% was par-

tial. Toxicity included localised skin reaction controlled

with a paraffin-based skin cream17

. Further trials are ongoing with a view to obtaining a license. The potentialadvance of Miltefosine is an application that may checktumour progression through the skin without the sideeffects associated with systemic anti-cancer agents.

Ethnographic Study of the Dying Process

Lawtons study within a hospice setting gives a profound

insight into the loss of self associated with the destruc-tion of the body through invasive disease. Lawton18 viewed

hospices as institutions in which a particular type of bod-

ily deterioration and decay is set apart from mainstreamsociety. She observed that most symptoms requiring con-trol appeared to share a distinctive feature in common:they were associated with, or caused, a rupturing andbreakdown of the surfaces of a patients body. As a conse-quence, fluids and matter normally contained within thebody were leaked and emitted to the outside, often in anuncontrolled and ad hoc fashion (p. 128). Lawtons con-tribution to the topic of fungating wound management

includes a critical insight into the reaction of individualsand society at large to the consequences of disfiguring

illness18

.

Survey of Dressing Usage for

Malignant Wound Management

Wilkes et al19 used a modified version of Thomas2 surveyinstrument to determine what nurses use to dress malig-nant wounds. The survey is the first part of a three-phasestudy and adds an international perspective to research onthe topic, as it is conducted in New South Wale, Australia.The second phase will explore decision-making in relationto wound care with expert palliative care nurses. The thirdphase will determine how patients cope with fungating

wounds, through qualitative interviews. The researcherspresent evidence of the complexities faced by nurses in

selecting dressings. Additional qualitative data reveal ma-jor unsolved issues that include odour management andmeeting the costs of dressings. The researchers also con-cluded that there are no clear recommendations to guidenursing practice19. This study advances knowledge of theoutstanding problems in malignant wound managementand provides a framework that may contribute guidelinesfor best practice.

Wound and Symptom Self -Assessment Chart

(WoSSAC)

Naylor et al20

published the above tool in the Handbookof Wound Management in Cancer Care. The Handbookis in itself a useful resource in meeting the goals of evi-dence-based clinical practice. The self-assessment tool wasdeveloped by one of the authors for a degree dissertationbut has not been validated. The tool is comprehensive andincludes self-assessment of a number of symptoms such aspain and bleeding, together with issues concerning the

intrusion of dressing changes and the level of social sup-port given. In addition the respondents are asked to quan-

tify feelings of shame, guilt, embarrassment, appearance

and impact on relationships with a partner. These psycho-social aspects may be derived legitimately from the litera-ture and located in accumulated professional experiencesof helping patients with advanced wounds, such as fun-gating wounds. However it may be inappropriate to as-sume that such highly personal feelings are generalisableto a population of patients. In effect the questions imposeon the patient attitudes that Lawton18 identified as preva-lent in society at large, that may culminate in a loss of self

in the face of disfiguring illness. Although this tool mayin the future constitute an advance in the assessment of

fungating wounds it would have been better not to pub-lish it before validation, particularly before its acceptabil-ity to respondents is demonstrated.

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SUMMARY AND CONCLUSIONSIn this review an advance in fungating wound manage-ment was the priority accorded to the topic in a Delphistudy of research priorities in cancer and palliative care.The literature review on metronidazole challenged currentapproaches to the management of odour and suggestednew lines of inquiry. The theoretical work on the antimi-crobial action of honey, together with clinical insights fromDunford et al15 on the debriding and dedodorising effectsof honey from the Leptospermum species indicated poten-

tial problem-solving research for this distressing problem.The studies on the analgesic properties of topical opiates

contributed theoretical and case study evidence of a use-ful symptom control measure for cutaneous pain. Clini-cal trial data for a topical palliative treatment, Miltefosine,show a promising advance in terms of an agent to checkskin metastases from breast cancer. The authors studycontributed a novel approach to generating clinical evi-dence of fungating wound management, together withexplanations of dressing performance and the qualificationof moist wound healing theory to accommodate exudate

management in fungating wounds. Lawtons18 ethnogra-

phy into the dying process in a hospice explained current

attitudes towards illness, which can lead to the loss of selfin the face of the kind of bodily deterioration evidencedin fungating wounds. A staging system and a self-assess-ment tool for malignant cutaneous wounds have the po-tential to foster a common approach to describe fungat-ing wounds, evaluate progression, and interventions. How-ever limitations in the application of both instrumentswere found16,20. The replication of Thomas2 survey by the

Australian authors increases understanding of this topic atan international level.

The main stays of the management of fungating

wounds are anti-cancer treatments, symptom control, lo-cal wound management and supportive care. Lawtons18

study indicated that body boundaries could be reinstatedby effective symptom control. Since 1991 there has beena lack of advances in clinical management options, particu-larly with regard to wound dressings. In a free paper to theEWMA 1991conference the author concluded:... the examples given demonstrate the inability of dressing

materials to conform to the shape of the body and to absorb

exudate effectively ... (Grocott 1991) 21 p 88-91.

The following key conclusion was drawn in the qualita-tive evaluation study (Grocott 1999)1:... a pivotal relationship between dressings and exudate

was found, which accounted for a significant number of

problems identified for fungating wound management,

including the psychosocial impact of living with an uncon-

trolled wound... (Grocott 1999) p 223.

Key advances in the management of exudate from 2001onwards may be derived from a collaborative project into

the objective assessment of dressings for chronic woundexudate management. The Engineering and Physical

Sciences Research Council are funding the project.

References

1. Grocott P. 1999. An Evaluation of the Palliative Management of FungatingMalignant Wounds, within a Multiple-Case study Design. Kings College London,University of London.

2. Thomas S. 1992. Current Practices in the Management of Fungating Lesions andRadiation Damaged Skin. Mid Glamorgan, Surgical Materials Testing Laboratory.

3. Cawley N. and Webber J. 1995. Research priorities in palliative care.International Journal of Palliative Nursing 1(2): 101-113.

4. Moyle J. 1998. The management of malodour. European Journal of Palliative Care5(5): 148-151.

5. Hampson J. P. 1996. The use of metronidazole in the treatment of malodorouswounds. Journal of Wound Care 5(9): 421-426.

6. Twycross, R. Symptom Management in Advanced Cancer. 2nd

edn. Oxford, 1997.7. Back I. N. and Finlay I. 1995. Analgesic effect of topical opioids on painful

skin ulcers. Journal of Pain and Symptom Control 10(7): 493.

8. Krajnik M. and Zylicz Z. 1997. Topical morphine for cutaneous cancer pain.Palliative Medicine 11(4): 326.

9. Krajnik M., Zylicz A. and Finlay I. 1999. Potential use of topical opioids inpalliative care report of six cases. Pain 80: 121-25.

10. Grocott P. 2000. Palliative management of fungating malignant wounds.Journal of Community Nursing 14(3): 31-40.

11. Hanks G. and Cherny N. 1998. Opioid analgesic therapy. Oxford Textbook ofPalliative Medicine. Doyle D., Hanks G. and MacDonald N. Oxford.,Oxford Medical Publications. 2: 331-355.

12. Grocott P, Cowley S. The palliative management of fungating malignant wounds generalising from multiple-case study data using a system of reasoning.Int J Nurs Stud. 2001 Oct; 38(5): 533-45.

13. Cooper R. and Molan P. 1999. The use of honey as an antiseptic in managing

Pseudomonas infection. Journal of Wound Care 8(4): 161-169.14. Molan P. C. 1999. The role of honey in the management of wounds.

Journal of Wound Care 8(8): 415-418.

15. Dunford C., Cooper R., Molan P. and White R. 2000.The use of honey in wound management. Nursing Standard 15(22): 63-68.

16. Haisfield-Wolfe M. E. and Baxendale-Cox L. M. 1999. Staging of malignantcutaneous wounds: A pilot study. Oncology Nurse Forum 26(6): 1055-1064.

17. Terwogt J., Mandjes J., Sindermann H., Beijnen J. and ten Bokkel Huinink W. 1999.Phase II trial of topically applied miltefosine solution in patients with skin-metastasized breast cancer. British Journal of Cancer 79(7-8): 1158-61.

18. Lawton J. 2000. The Dying Process. London, Routledge.

19. Wilkes L., White K., Smeal T. and Beale B. 2001. Malignant wound management:what dressings do nurses use? Journal of Wound Care 10(3): 65-72.

20. Naylor W. 2000. Development of a Symptom Self-Assessment Tool for Patientswith Malignant Cutaneous Wounds. Manchester, University of Manchester.

21. Grocott P. 1991. Application of the principles of modern wound management

to complex wounds in palliative care. 1st European Conference on Advancesin Wound Management., Cardiff, Macmillan Magazines Ltd.

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Clinical Article

BACKGROUNDWhen the Nurses Association for the Study ofSkin Wounds (A.I.S.Le.C) was founded in 1995,

it set its objectives as promoting the quality of carethrough extensive research using data from Italy

and abroad. AISLeC has trained over 7000 healthprofessional in seven years of work and three stud-ies have been conducted involving a total of 1760colleagues and 8240 patients from 297 wards.

From these studies weve been able to see if theposition of the patients was changed at regularintervals while confined in bed, be it by their ownpower or assisted by health professionals. Wechecked if anti-pressure sore beds were used and

which medications were used. We also evaluatedthe level of assistance given to patients in home

care treatments. We have looked at mobilisationand the use of assistance for preventive treatmentof pressure ulcers in home care,12.

These studies have enabled us to inform theItalian people and the Italian Health Ministryabout this important problem and to improvequality assurance.

PREVALENCE OF PRESSURE ULCERSIn Italy in 1984, 8.6% of hospital patients had

pressure sore lesions3. This caused their hospital

stay to increase by 69 days and it also increasedthe cost by 7 million liras per lesion4. The totalcost of medical care for these problems was morethan 5000 billion lira. AISLeC research has alsodemonstrated that the prevalence of pressure ul-cers in Italian hospitals was increasing: 50% morepatients in hospital had pressure sores in 1994than in 1984 (from 8.6% in 1984 to 13.2% in1994)1. This continues to increase, and the study

conducted in 19962 has shown the prevalence ofpressure sore lesions to be 18.3% for those in the

hospital setting and 32.19% for those in the homecare environment.

When we consider other skin lesions, we have asimilar incidence to the rest of the developedworld. We know from the literature on this topicthat vascular lesions afflict 1% of the adult popu-

lation5. Among those less than 40 years old theprevalence is low, but it increases with age, reach-

ing its peak among those in the age group 70 to

90 years with a female to male ratio of 3:1. Thesefigures are comparable to those found in Italy.

It has been stated that the skin care problem willliterally be a demographic time bomb6 for indus-trialised countries, because of the ageing popula-tion. The over-65 age group (presently 20%) willdouble in the forthcoming years putting greatemphasis on skin care. These figures motivated usto conduct this study.

Research objective: To promote quality assistancein home care for wounds and skin care.

Rationale for the study: Poor knowledge of professional healthcare

givers about pressure ulceration High costs for administration care and

population Lack of studies on this matter in home

healthcare The desire of the Italian health administra-

tion to improve home healthcare

Wound Management

in Home Care in Italy

Papers presented atEWMA Dublin 2001

A. BellingeriRNIRCCS

S. Matteo di Pavia

(Policlinic University)

Worked in Intensive Care,

OR, Ambulatory service

and presently in a

pharmacy.

Teacher in 32 courses

(14 hereof University

courses on wound-care)

President of AISLeC

(Nurses Association for

the Study of Skin Wounds)

From 1995 Honour

member of AIUC (Italian

Ulcer Society)

EPUAP Trustees Member

of Commission Research

of Italian Nurses Council

Coordinator in nursing

research projects (three of

these multicentered with

30, 35 e 22 Hospitals)

Co-authors:B. Paggi

S. Bonelli

M. Bergognoni

A. Calosso

P. Deriu

E. Zanetti

M. Bonvento

A. Cavicchioli

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Age (years) F % M % Total %

0-44 38.8 61.2 2.62

45-54 50 50 2.74

55-64 51.8 48.2 6.43

65-74 57.0 43 19.45

75-84 66.9 33.1 35.89

>84 74.79 25.21 32.83

Total 65.43 34.57 100Table 1. Age and gender of patients.

Two out of three patients were women and more than 67%of all the patients in the study were over 74 years old, seetable 1.

The risk of developing pressure sore lesions was used as thebasis for evaluating the patients. This, as in the precedingstudies promoted by the Association, was done using theNorton Score. Essentially, the results have confirmed theprevious results: over 50% of surveyer home care patientswere found to be at risk of developing ulcers (from thepresent study 53.28% were at risk and in the 1996 study55.3% were at risk).

Age (years) Patients % Patients at risk

0-44 30/19 61%

45-54 29/59 49%

55-64 51/117 44%

65-74 144/380 38%

75-84 342/709 48%

>84 475/696 68%

Total 1071/2010 53%Table 2. Number of patients at risk of developing pressuresore lesions and their corresponding age groups.

Purpose of the project:

To estimate the size of the chronic skin lesion problem andreport how personnel responsible for providing homehealth care assistance perceived it.

Description of the project:

The project was to: determine the prevalence of cutaneous lesions determine which medical treatment and procedures

were used determine how detailed nurses knowledge was on

the topic of chronic wounds, the different types ofskin lesions and their management

Methodology

Much of home health care in Italy is delivered by lay carers,therefore we decided to divide the work into two parts.

In the first part, nurses were asked about the organiza-tion of homecare assistance

Documents

2002 2002-05-07