9
ABSTRACT “Least costly but most effective” has never been more important to healthcare delivery than in the current healthcare environment of changing reimbursement systems. In wound care, the high costs associ- ated with renting advanced support surfaces may be an area where expenses can be decreased if similar outcomes can be attained by using more affordable mattresses. This article compares the healing rates and eventual outcomes of wounds among two groups of patients randomly assigned to one of two support surfaces. A commonly used low-air-loss mattress was compared with the study mattress, an advanced, non- powered, air and foam surface. Subjects were patients admitted to either of two long-term healthcare settings for the treatment of wounds. The resulting two groups of 10 patients each were evenly matched for average age and percentage of patients who were nutritionally deficient as indicated by albumin or pre-albumin levels. The presence of gas- trointestinal tubes and ventilator dependency also was recorded. Consistent wound care protocols were used on both groups, including turning schedules, nutrition, topical medication, and dressings. The study period covered a maximum of 8 weeks; interest was centered on the rate of wound healing and progress toward a goal rather than the length of time to completely close a wound. After 8 weeks, or upon dis- charge from the study, pressure ulcers in the study mattress group closed at an average rate per week of 9.0% ± 4.8 versus 5.0% ± 3.7 in the low-air-loss mattress group. This study indicates that the study mattress can provide benefits to the wound healing process similar to or better than low-air-loss mattresses at a substantially reduced cost. Ostomy/Wound Management 2001;47(9):38–46 I n today’s healthcare arena, the prevention and treat- ment of pressure ulcers continues to present a chal- lenging and costly focus for healthcare professionals. The most difficult task is to spread limited healthcare dol- lars over as large a patient base as possible; therefore, the least costly but most effective products must be utilized. The cornerstone of treating pressure ulcers is the removal or alleviation of pressure, the underlying cause of the condition. Powered specialty mattresses play an important role in this aspect of treatment. However, due to the confusing results of past studies, the role of special- ty mattresses in the treatment of pressure ulcers remains controversial. 1 Specialty mattresses usually are rented and costly to the entire healthcare system, but the question remains as to whether that expense is justified by wound healing that is faster than less expensive measures. Several studies have found the incidence of pressure ulcers to be between 2.7% and 29% in hospitals and from 1.9% to 28% in skilled nursing facilities and nurs- ing homes. 2 The impact of pressure ulcers can be seen both in human and economic terms. In human terms, the geriatric patient who develops a pressure ulcer has a fourfold increased risk of death. 3 In economic terms, esti- mating the cost of healing pressure ulcers is difficult because of the complexity of individual treatment, including depth of wound, nutritional compromise, need for hospitalization, medications, modalities (eg, electrical 38 Ostomy Wound Management “Constant Force Technology” versus Low-Air-Loss Therapy in the Treatment of Pressure Ulcers Raquel Branom, RN, BSN, CWOCN, and Laurie M. Rappl, PT, CWS At the time she wrote this manuscript, Ms. Branom was an enterostomal therapist with Vencor, San Diego, Calf. She is now the wound/ostomy/continence nurse consultant for Sharp Home Care, San Diego, Calf. Ms. Rappl is the Clinical Support Manager for Span-America Medical Systems Inc., Greenville, SC. Address correspondence to: Laurie M. Rappl, PT, CWS, P.O. Box 5231, Greenville, SC 29606; email [email protected].

“Constant Force Technology” versus Low-Air-Loss ... Stage II pressure ulcer, including hospitalization, was $1,119 ±$4,234. The mean cost to heal a Stage III or IV ulcer, including

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Page 1: “Constant Force Technology” versus Low-Air-Loss ... Stage II pressure ulcer, including hospitalization, was $1,119 ±$4,234. The mean cost to heal a Stage III or IV ulcer, including

ABSTRACT“Least costly but most effective” has never been more important tohealthcare delivery than in the current healthcare environment ofchanging reimbursement systems. In wound care, the high costs associ-ated with renting advanced support surfaces may be an area whereexpenses can be decreased if similar outcomes can be attained by usingmore affordable mattresses. This article compares the healing rates andeventual outcomes of wounds among two groups of patients randomlyassigned to one of two support surfaces. A commonly used low-air-lossmattress was compared with the study mattress, an advanced, non-powered, air and foam surface. Subjects were patients admitted toeither of two long-term healthcare settings for the treatment of wounds.The resulting two groups of 10 patients each were evenly matched foraverage age and percentage of patients who were nutritionally deficientas indicated by albumin or pre-albumin levels. The presence of gas-trointestinal tubes and ventilator dependency also was recorded.Consistent wound care protocols were used on both groups, includingturning schedules, nutrition, topical medication, and dressings. Thestudy period covered a maximum of 8 weeks; interest was centered onthe rate of wound healing and progress toward a goal rather than thelength of time to completely close a wound. After 8 weeks, or upon dis-charge from the study, pressure ulcers in the study mattress group closedat an average rate per week of 9.0% ± 4.8 versus 5.0% ± 3.7 in thelow-air-loss mattress group. This study indicates that the study mattresscan provide benefits to the wound healing process similar to or betterthan low-air-loss mattresses at a substantially reduced cost.

Ostomy/Wound Management 2001;47(9):38–46

In today’s healthcare arena, the prevention and treat-

ment of pressure ulcers continues to present a chal-

lenging and costly focus for healthcare professionals.

The most difficult task is to spread limited healthcare dol-

lars over as large a patient base as possible; therefore, the

least costly but most effective products must be utilized.

The cornerstone of treating pressure ulcers is the

removal or alleviation of pressure, the underlying cause of

the condition. Powered specialty mattresses play an

important role in this aspect of treatment. However, due

to the confusing results of past studies, the role of special-

ty mattresses in the treatment of pressure ulcers remains

controversial.1 Specialty mattresses usually are rented and

costly to the entire healthcare system, but the question

remains as to whether that expense is justified by wound

healing that is faster than less expensive measures.

Several studies have found the incidence of pressure

ulcers to be between 2.7% and 29% in hospitals and

from 1.9% to 28% in skilled nursing facilities and nurs-

ing homes.2 The impact of pressure ulcers can be seen

both in human and economic terms. In human terms,

the geriatric patient who develops a pressure ulcer has a

fourfold increased risk of death.3 In economic terms, esti-

mating the cost of healing pressure ulcers is difficult

because of the complexity of individual treatment,

including depth of wound, nutritional compromise, need

for hospitalization, medications, modalities (eg, electrical

38 OstomyWound Management

“Constant Force Technology”versus Low-Air-Loss Therapyin the Treatment of Pressure Ulcers– Raquel Branom, RN, BSN, CWOCN, and Laurie M. Rappl, PT, CWS

At the time she wrote this manuscript, Ms. Branom was an enterostomal therapist with Vencor, San Diego, Calf. She is now thewound/ostomy/continence nurse consultant for Sharp Home Care, San Diego, Calf. Ms. Rappl is the Clinical Support Manager forSpan-America Medical Systems Inc., Greenville, SC. Address correspondence to: Laurie M. Rappl, PT, CWS, P.O. Box 5231,Greenville, SC 29606; email [email protected].

Page 2: “Constant Force Technology” versus Low-Air-Loss ... Stage II pressure ulcer, including hospitalization, was $1,119 ±$4,234. The mean cost to heal a Stage III or IV ulcer, including

stimulation or pulsed lavage), dressings, and equipment.

Xakellis and Frantz4 reported the mean cost to heal a

Stage II pressure ulcer, including hospitalization, was

$1,119 ± $4,234. The mean cost to heal a Stage III or IV

ulcer, including hospitalization, was $10,185 ± $27,635.

The mean cost to heal each ulcer in the Xakellis and

Frantz study was $2,731 ± $12,184.

The AHCPR’s Clinical Practice Guidelinee Number 3:Pressure Ulcers in Adults: Prediction and Prevention5 states

“any individual assessed to be at risk for developing pres-

sure ulcers should be placed when lying in bed on a pres-

sure-reducing device such as foam, static air, alternating

air, gel, or water mattress.” Medicare has divided mat-

tresses into three distinct groups, each with clinical crite-

ria the patient must meet to qualify for reimbursement.

Basically, Group I surfaces include static surfaces that are

provided for prevention and for the first line in interven-

tion for pressure ulcers. Group III mattresses include air-

fluidized surfaces. This study concentrated on Group II

surfaces.

The majority of Group II surfaces are powered mat-

tresses, usually either low-air-loss (LAL) or alternating air

surfaces. Group II surfaces are used for those patients

who meet one of the following criteria:

• multiple Stage II pressure ulcers on the trunk or

pelvis

• comprehensive ulcer treatment for past 30 days

with Group I product

• ulcers have worsened or remained the same over

the past month

• large or multiple Stage III or IV ulcers on pelvis

or trunk

• recent myocutaneous flap or skin graft

on trunk or pelvis and the patient has

been on a Group II or III surface

immediately prior to a recent discharge

from a hospital or nursing facility.6

Low-air-loss mattresses (designated Group

II) were designed to reduce body interface

pressure to below capillary closing pressure

(32 mm Hg), to distribute weight evenly

(pressure relief ), and to limit friction and

shear.7,8 In the literature, several researchers

have attempted to prove the efficacy of LAL

mattresses in the treatment of pressure ulcers.

Some of these studies use interface pressure

measurements. Others use reduction in

wound measurements rather than final patient outcome

with complete wound closure. Some studies show no sig-

nificant improvement in patient outcomes, such as pres-

sure ulcer healing, when the patient is treated on an LAL

mattress.9 Often a study yields confusing results. For

example, in a study conducted by Ferrell et al, an LAL

mattress was compared to a 4-inch foam mattress overlay.

The study results showed no significant difference in

healing rates of deep wounds between the two surfaces,

but the researchers did see improved healing of superfi-

cial ulcers in subjects treated on an LAL mattress.10

Mulder et al compared an LAL mattress to a foam over-

lay. They noted a significant increase in rate of healing

among subjects treated on LAL as compared to subjects

treated on the overlays. However, in the same study, the

researchers found no significant difference in the percent-

age of wounds that healed completely between the two

groups.11 Day and Leonard compared the healing rates of

187 patients on LAL versus a unique foam overlay, the

Geo-Matt (Span-America Medical Systems, Inc.,

Greenville, SC). They found no significant difference in

healing rates of pressure ulcers between these two groups.12

GoalsThe goal of this pilot study was to determine if costs

could be decreased by purchasing a less expensive mat-

tress than an LAL while maintaining or improving

patient outcomes. In everyday practice, selecting a sup-

port surface goes beyond choosing what has worked

before and what information is available in the literature.

Today’s clinician must weigh the individual needs of the

September 2001 Vol. 47 Issue 9 39

KEY POINTS❏ Because support surface rental costs can be substantial,many facilities are

considering their purchase.However, few studies have been conducted tocompare the effectiveness and efficacy of different support surfaces.

❏ To ascertain whether replacing currently used low-air-loss mattresseswith nonpowered air and foam surfaces would affect outcomes, theauthors conducted a pilot study involving 20 patients with Stage III andIV pressure ulcers.

❏ Following randomization, outcomes in patients placed on the nonpow-ered surface were similar or better than those obtained in patients onthe low-air-loss mattresses.

❏ Sample size limitations prohibited statistical analysis of the resultsobtained, but additional studies, involving a larger sample size, seem war-ranted, given the potential cost savings.

Ostomy/Wound Management 2001;47(9):38–46

Page 3: “Constant Force Technology” versus Low-Air-Loss ... Stage II pressure ulcer, including hospitalization, was $1,119 ±$4,234. The mean cost to heal a Stage III or IV ulcer, including

patient, the drive for positive patient outcomes, the avail-

ability of cost-effective products, and the reimbursement

for the chosen surface by third-party payors. More than

100 types of pressure-reducing devices are available, rang-

ing from the low-cost foam or static air overlays to the

more expensive and widely used LAL mattresses to air-

fluidized beds. Rented LAL mattresses can be a great

expense. The average rental cost billed to Medicare is

approximately $700 per month. Some manufacturers will

rent these surfaces for as little as $10 per day or as much

as $145 per day. When purchasing a specialty bed, the

facility can expect to spend thousands of dollars per bed.

Skyrocketing healthcare costs, recent changes in reim-

bursement to long-term care under PPS for Medicare

patients under Part A, and further changes in Medicare

guidelines that will effect reimbursement by third-party

payors using the Medicare guidelines for guidance in cri-

teria for payment make it essential for clinicians to evalu-

ate new products that can provide superior pressure

reduction and patient outcomes in the least costly man-

ner. Long-term-care facilities can no longer rely on reim-

bursement from a third party. Under PPS regulations for

long-term care, facilities now must pay out-of-pocket for

durable medical equipment rental or purchase from a

fixed rate they receive for the patient’s total care. For

many, purchase of equipment that was previously rented

will make more financial sense in the long run. This

financial investment must be made carefully and must be

based on cost-effective outcomes.

The two mattresses compared include a standard, well-

known, structurally comparable LAL surface and the

PressureGuard® CFT (Constant Force Technology)™ by

Span-America Medical Systems Inc. (Greenville, SC),

hereafter referred to as “study mattress.” This mattress is

nonpowered and comprises a series of interconnected air

tubes and elasticized air reservoirs with a Geo-Matt cut

foam topper as the patient interface layer. The manufac-

turer’s pressure mappings show that it equalizes pressure

over the weight-bearing surface of the patient’s body.

Low-air-loss mattresses also equalize pressure but with air

intake and outflow rather than movement within a fully

enclosed system. The two measurable areas of patient

outcomes were:

1. Meeting the goals of wound treatment as deter-mined by the team. Goals included progressive

closure, preparation for flap, and maintenance of

condition. Maintenance of condition is frequently

an appropriate goal if the patient’s condition is

deteriorating and other health concerns are more

pressing than skin care. Each wound was rated

“achieved,” “not achieved,” or “exceeded.” The goal

of progressive closure was considered achieved if

the wound showed progress toward closure.

2. The rate of wound healing over time, with amaximum of 8 weeks. The goal was to deter-

mine the rate of wound closure, expressed as a

percentage of the original wound, rather than

whether or not the wound fully closed during

the study period. The author reports measure-

ments at 3 weeks and at exit from the study to

determine if wound healing slowed or accelerat-

ed as the wound decreased in size. This helped

determine if one mattress outperformed the

other at an interim time point as well as at the

end point – a consistency that added confidence

to the findings.

If the study mattress matched the LAL surfaces in

patient treatment, acquisition costs would save the partic-

ipating facilities thousands of dollars in either rental or

purchase of LAL in a very short time.

MethodologyThis pilot study was set up as a prospective, random-

ized clinical trial involving 20 patients who had Stage III

or IV pressure ulcers on the trunk or pelvis.

Inclusion criteria:

1. The patient was admitted as an inpatient to one

of the two test sites.

2. The patient had pressure ulcer(s) at Stage III or

IV on the trunk or pelvis.

3. The patient was bedridden, necessitating pres-

sure distribution off of bony prominences and

ulcer site(s).

If a patient was admitted to the study with more than

one pressure ulcer, only the deeper ulcer was followed in

the study. Poor health status of a patient negatively

affects wound healing on all of that patient’s wounds.

One patient with many wounds would have an unequally

large effect on the results for that mattress, either positive

or negative.

Sites. Two facility sites were used. Vencor Hospital is a

70-bed, acute care hospital in San Diego, California spe-

cializing in ventilator-dependent patients and patients

with extensive wound care needs. Horizon Health and

40 OstomyWound Management

Page 4: “Constant Force Technology” versus Low-Air-Loss ... Stage II pressure ulcer, including hospitalization, was $1,119 ±$4,234. The mean cost to heal a Stage III or IV ulcer, including

Sub-Acute Center in Fresno, California, is a 225-bed

long-term and subacute care center. These two sites have

relatively homogenous patient profiles and lengths of

stay, wound care protocols including use of LAL mattress

replacements, and employ moist wound healing with

nutrition intervention. Certified enterostomal therapy

(ET) nurses direct their wound care programs and each

facility has developed a reputation in their respective geo-

graphic area for excellence in wound care.

Mattress assignment. For simplicity, each facility used

a brand of LAL most familiar to its staff and equally

approved as reimbursable, Group II surfaces under

Medicare Guidelines. Each LAL surface vented air in the

same manner and the capacity of the pumps to generate

airflow through the mattresses (approximately 130

L/minute) was nearly equal. The two brands are widely

used in the United States.

Patients who met the inclusion criteria were randomly

assigned to one of the two groups, the study mattress or

LAL, in an alternating pattern as they were admitted.

The first patient admitted, who required a special sup-

port surface as part of ulcer treatment, was placed on the

LAL, the second patient admitted was placed on the

study mattress, the third patient on the LAL, and so on.

Ten patients were placed on the study mattress and 10

were placed on the LAL.

Unfortunately, as often happens in patient-oriented

research, two of the LAL patients were switched to the

study mattress during their treatment upon physician’s

orders, despite inclusion in the study. Hence, the num-

bers of patients in the results show 10 on the study mat-

tress and only eight on LAL. The outcomes of these two

patients are discussed separately in the results that follow;

they are not included in the data analysis.

Data collection. Data collected on each patient

included: age, albumin or pre-albumin, g-tube, ventilator

dependency, site and size of ulcer, presence of eschar, and

the goal for wound healing.

Albumin/pre-albumin. Albumin or pre-albumin

determined nutritional status. A normal albumin range

of 3.3 g/dL to 4.5 g/dL was used for this study.7 An

albumin level of less than 3.5 g/dL indicates the need

for detailed nutritional assessment and possible inter-

vention.7 Albumin levels below 3.0 g/dL have been

associated with poor wound healing outcomes.13 A nor-

mal pre-albumin range of 20 g/dL to 40 g/dL was used

for this study.7

G-tube/ventilator dependency. These features were

recorded because patients with g-tubes for enteral feed-

ings or who are dependent on ventilators are more med-

ically fragile. A concentration of these fragile patients in

one of the two groups could negatively affect the com-

parison of outcomes.

Wound measurements. Length, width, and depth, in

centimeters, were taken at 3 weeks and at end of the

study and weekly as clinicians were able. The data were

used to determine percent of wound healing that

occurred over the initial 3-week time period and over the

entire time the patient was in the study, up to the 8-week

limit. The interim 3-week measurement was included to

see if wound healing accelerated over time and to note if

one mattress outperformed the other at an interim time

point as well as at the end point.

Goal for healing. Each subject was evaluated and the

wound care team established a goal for wound healing –

progressive closure, maintenance, or preparation for flap

surgery – rather than completion of the wound healing

process. The team included the patient and/or family, the

ET nurse, nursing staff, and the patient’s primary physi-

cian. These goals were established according to the

patient’s medical condition, prognosis, quality of life, age,

and level of debilitation. At the end of the study, patients

were rated as having achieved their goal, not having

achieved their goal, or having exceeded their goal. For

example, if the patient’s condition made maintenance of

the wound a reasonable goal, but the patient showed

progress toward closure of the wound, the patient was

scored as having exceeded his/her goal.

Exit criteria. Eight weeks was the maximum time for

participation in this study. Again, the goal was to determine

differences in rate of wound closure and progress toward the

stated goal. Therefore, a defined endpoint was necessary to

calculate final size percentages. Other than the 8-week time

limit, study exit criteria also included death, discharge from

inpatient status, or flap surgery. Data for those patients who

did not complete the full 8-week time period are calculated

using the number of weeks they did participate.

Topical wound care. The topical wound care proto-

cols in each facility were similar. These protocols were

based on the principals of moist wound healing, as

described in the AHCPR Clinical Practice Guidelines forthe Treatment of Pressure Ulcers,2 and the Clinicians PocketGuide to Chronic Wound Repair (see Table 1 for a

description of the topical wound protocols).13

September 2001 Vol. 47 Issue 9 41

Page 5: “Constant Force Technology” versus Low-Air-Loss ... Stage II pressure ulcer, including hospitalization, was $1,119 ±$4,234. The mean cost to heal a Stage III or IV ulcer, including

The protocols also included patient positioning in

bed, including positioning off of the ulcer site at all times

if able, and employing the 30-degree, side-lying oblique

position. This position provides pressure relief for the

sacrum and both trochanters.8 Position changes were per-

formed at regular 2-hour intervals.

Comparison of study groups. Upon admission to the

study, the two groups were

evenly matched in average

age (see Table 2).The two

groups were also evenly

matched in the percentage

of patients who were nutri-

tionally deficient as indicat-

ed by albumin or pre-albu-

min levels. The average

albumin level, taken at the

time of admission was 2.5,

significantly below the 3.5

threshold cited above. The

average pre-albumin was

14.7, significantly below

the threshold of 20 cited

above. The two groups

were also fairly evenly

matched in the numbers of

patients who used g-tubes – seven of 10 in

the study mattress group and five of eight in

the LAL group. The LAL group had more

ventilator-dependent patients than the study

mattress group – five of eight (63%) versus

four of 10 (40%).

Meeting wound treatment goal. Data

gathered summarize the results, comparing

goals, results, and average rate of wound clo-

sure of the two groups (see Table 3). This

chart includes data on the two patients who

were switched from LAL to constant force

technology. These data were not analyzed sta-

tistically as these patients are presented for

added information only; they did not com-

plete the study on the same mattress, but their

results are of interest as case studies. Two

wounds on one patient who switched surfaces

are described in the results, although only one

wound per patient was followed in the

patients who started and completed the study

on the same mattress.

Under “Goal for Wound,” “Achieved” included those

patients who fully met or were progressing toward meet-

ing their established goal of progressive closure or main-

tenance, whether the wound was completely closed or

not at the end of the 8-week study. “Exceeded” included

those patients who had maintenance as their goal and

42 OstomyWound Management

TABLE 2PATIENT PROFILES

Study Mattress

LALRemained on LAL

Switched from LALto Study Mattress

1010

36-100 72.8

8 (80%)

7 (70%)4 (40%)

7 (70%)3 (30%)

3 (30%)7 (70%)

88

48-9070.5

7 (88%)

5 (63%)5 (63%)

7 (88%)1 (12%)

2 (25%)6 (75%)

23

67-7671.5

1

00

21

3

Number of patientsNumber of woundsAge range (years)Mean age (years)Albumin < 3.5 orpre-albumin < 18G-tubeVentilator dependentUlcer site

Sacrum/coccyxTrochanter

Ulcer stageIIIIV

TABLE 1TOPICAL WOUND CARE PROTOCOLS

Irrigate all wounds with 120 cc of normal saline using a 35-cc syringeand 20-gauge anglocath.

Apply appropriate topical dressing based on the following criteria:• Superficial wounds with minimal amount of drainage

Perform one of the following:• Apply hydrogel to wound bed, cover with gauze• Cover wound with thin foam dressing• Cover wound with transparent film

• Wounds with depth or cavity with minimal amount of drainagePack wound with hydrogel impregnated gauze and apply coverdressing

• Superficial wounds with moderate to large amount of drainageCover with foam dressing, with or without calcium alginateApply calcium alginate and cover with hydrocolloid dressing

• Wounds with depth or cavity with moderate to large amountof drainage Pack wound with calcium alginate, cover with gauze, foam dressing,or hydrocolloid

Page 6: “Constant Force Technology” versus Low-Air-Loss ... Stage II pressure ulcer, including hospitalization, was $1,119 ±$4,234. The mean cost to heal a Stage III or IV ulcer, including

who progressed toward closure during the study. “Not

achieved” included those patients who did not meet their

goals for either progressive closure or maintenance. Table

4 compares the goals for wound healing with the results

achieved for each of the two groups.

In the study mattress group, the goal for four of the

10 patients was progressive closure, five had maintenance

as the goal, and one patient received wound care as

preparation for flap surgery. In the LAL group, the goal

for five of the eight patients was progressive closure, two

had maintenance as their goal, and one received wound

care in preparation for flap surgery.

All 10 patients on the study mattress (100%) achieved

or exceeded their goals during the study period. Five of the

eight patients treated on the LAL achieved or exceeded

their goals.

Rate of wound healing. The rates of wound closure

at 3 weeks and at the end of the study are summarized in

Table 5. These rates were determined by comparing the

total change in wound volume in cm3 and in the percent-

age of change from the original wound. The author used

wound volume rather than area, so length, width, and

depth were recorded on each wound.

In the following equations used as part of this process,

X = either 3 weeks or the number of weeks in the study

(see Table 6). The number of weeks in the study was a

maximum of 8-weeks as discussed earlier in this article

(see Table 5).

The resulting numbers in each group were averaged.

At the end of 3 weeks, wounds in each group had closed

by nearly the same volume (17.0 cm3 and 17.1 cm3

respectively) and, therefore, at the same rate per week

September 2001 Vol. 47 Issue 9 43

TABLE 3RESULTS FOR WOUND TREATMENT AND RATE OF CLOSURE

Study Mattress

LALRemained on LAL

Switched from LALto Study Mattress

10

415

7 (70%)3 (30%)

0Average 14.4% ± 11.1

Average 9.0% ± 4.75

8

512

4 (50%)1 (13%)3 (37%)

Average 7.2% ± 7.6

Average 5.0% ± 3.7

3

210

201

Number of woundsGoal for wound

Progressive ClosurePrepare for flapMaintenance

ResultsAchievedExceededNot achieved

Rate of wound closureas % over 3 weeks

Rate of wound closureas % at endpoint

TABLE 4GOALS FOR WOUND TREATMENT VS. RESULTS

ProgressiveClosure

(4)

Goal (Number of patients

with this goal)

Study Mattress

4

Prepare for flap

(1)

1

Maintain

(5)

23

ProgressiveClosure

(5)

LAL

3

2

Prepare for flap

(1)

1

Maintain

(2)

11

Results:AchievedExceededNot achieved

Page 7: “Constant Force Technology” versus Low-Air-Loss ... Stage II pressure ulcer, including hospitalization, was $1,119 ±$4,234. The mean cost to heal a Stage III or IV ulcer, including

(5.7 cm3). However, as a percentage of the total wound

closed in 3 weeks, the study mattress group outper-

formed the LAL group 43% to 21.8%.

At the end of the study period, the average volume

closed was nearly equal (25.8 cm3 versus 22.2 cm3).

However, the average rate of closure per week was higher

on the study mattress (3.5 versus 2.8) as was the average

percentage closed (60% versus 39.6%).

At 3 weeks, the average rate of wound closure per

week as a percentage of the original wound was 14.4% ±

11.1 on the study mattress and 7.2% ± 7.6 on the LAL.

At 8 weeks, or the end of the study (whichever came first

for the individual patient) the average rate of wound clo-

sure per week as a percentage of the original wound was

9.0% ± 4.8 on the study mattress, compared with 5.0%

± 3.7 on the LAL.

During the study, two of the subjects, whose wounds

had reached a plateau in their healing, were switched

from the LAL mattress to the study mattress at the insis-

tence of their physicians. Data on two wounds on one

patient and one wound on the other are included in the

patient data tables to indicate the effects of each of the

two surfaces. One patient’s goal was for wound closure of

both sites, and the other patient’s wound was being pre-

pared for myocutaneous flap surgery.

On each of the two surfaces, Patient 1 showed short-

term improvement, then reached a plateau. During each

plateau period, the physician switched surfaces. Each

change in surface resulted in a 1-cm reduction in wound

depth; Patient 1 showed no difference in healing between

surfaces. It is believed that healing was impaired due to

history of pelvic radiation. The patient subsequently had

myocutanous flap surgery to close the wound.

Patient 2 had two Stage IV pressure ulcers. This

patient was on LAL for approximately 5 weeks. During

the first 2 weeks, the ulcers closed by 50% (trochanter)

and 86% (coccyx), respectively, then both stagnated in

their closure process. No contributing factors such as sig-

nificant change in health status, medications, or nutrition

were observed to account for this occurrence. The physi-

cian ordered the switch to the study mattress. Progressive

healing was again observed; after 4 weeks on the study

mattress, the wounds closed by 100% and 71% of the size

of the respective ulcer at the time the surface was switched

to the study mattress. No patients developed new ulcers

on either the study mattress or the LAL mattresses.

Over the 8-week study period, the daily rental cost of

the LAL mattresses was approximately $35.00/day, result-

ing in a total rental cost of $1,960.00 per patient over

the 8 weeks. In comparison, the purchase price (manu-

facturer’s suggested retail price) of the study mattress is

$1,080.00, or approximately 50% of rental costs over 8

weeks. Over time, further savings will be realized because

the study mattress will be available for future use.

DiscussionThe goal of this study was to determine if the cost of

an LAL mattress was justified in improved patient out-

44 OstomyWound Management

TABLE 5COMPARISON OF WOUNDS, HEALING RATES,AND HEALING

PERCENTAGES AT 3 WEEKS AND 8 WEEKS

1AverageSize atStart (cm3)

2AverageSize at 3 weeks(cm3)

3AverageAmountClosed (cm3)

4AverageRate ofclosure/

week(cm3)

5Average

% closed

6Average

%closed/week

7AverageSize at

d/cfromstudy(cm3)

8AverageAmountClosedat d/cfromstudy(cm3)

9AverageRate ofclosure/Week atd/c from

study (cm3)

10Average% closed

11Average

%closed/week

End of 3 Weeks

32.5

50.44

15.5

34.57

17.0

17.1

5.7

5.7

43.0

21.8

14.4%± 11.1

7.2%± 7.6

6.6

24.6

25.8

22.2

3.5

2.8

60.0

39.6

9.0%± 4.8

5.0%± 3.7

End of 8 Weeks or d/c from study

StudyMattress

LAL

d/c = discharged

Page 8: “Constant Force Technology” versus Low-Air-Loss ... Stage II pressure ulcer, including hospitalization, was $1,119 ±$4,234. The mean cost to heal a Stage III or IV ulcer, including

comes or whether similar or better out-

comes can be achieved by using tech-

nology that was less costly. The results

of the study showed that improved

patient outcomes, as seen by improved

healing rates, can be achieved when

using an alternative pressure-reducing

device, without incurring costly rental

or purchasing bills.

The study randomization yielded two

groups that were evenly matched for

nutritional deficiencies (low albumin or

pre-albumin), nutritional source (enter-

ally fed), and location of ulcers caused

by pressure secondary to immobility.

Although the majority of the subjects

were elderly, each group had one rela-

tively young subject (the study mattress

group had one 36-year-old; the LAL

group had one 49-year-old).

Dressing changes at both facilities follow similar pro-

tocols based on the AHCPR guidelines and the principles

of moist wound healing. Nursing care included routine

turning and re-positioning every 2 hours and nutritional

supplementation when needed. Protocols guided the staff

to keep the ulcer sites as free of pressure as possible with

frequent turning and appropriate positioning.

Without pressure testing each patient in every possible

position on each weight-bearing bony prominence on

both surfaces, making the generalized statement that

“surface X provides lower interface pressure than surface

Y for all patients” is impossible. From the results of this

study, likewise, this conclusion cannot be reached

because the author and her colleagues did not have access

to pressure mapping or sensors that would accurately

measure the interface pressures for the mattresses used.

The small sample size is an acknowledged limitation of

this study that may affect the conclusive results.

Additional randomized controlled studies consisting of a

larger patient sampling, comparison of support surfaces

across surface categories, including the study mattress,

and a longer period of study ending with full wound clo-

sure may prove to be of value.

Another limitation of this study is the use of two dif-

ferent LAL mattresses, even though they are nearly iden-

tical in structure, method of venting air to the environ-

ment, and capacity of blowers to move air through the

mattresses (approximately 130 L/minute). Using only

one brand of LAL mattress would eliminate the possible

factor of one LAL mattress performing differently from

the other and negatively affecting all LAL results.

Conclusion In relation to the two stated goals:

1. Meeting the goal of wound treatment: 100%

of the subjects on the study mattress met or

exceeded their goal for wound healing versus

63% of the LAL group.

2. Rate of wound healing over time: after 3 weeks,

pressure ulcers on subjects on the study mattress

closed at an average rate per week of 14.4% ±

11.1, while the LAL subjects’ pressure ulcers closed

at an average rate per week of 7.2% ± 7.6. After 8

weeks, or upon discharge from the study, the pres-

sure ulcers on subjects in the study mattress group

closed at an average rate per week of 9.0% ± 4.8,

as opposed to 5.0% ± 3.7 on the LAL.

This study suggests that the study mattress is an effec-

tive and lower cost alternative to the LAL mattresses in

positively affecting the rates of wound healing in patients

with Stage III and IV pressure ulcers. - OWM

Acknowledgment The mattresses used in the study were provided by

Span-America Medical Systems Inc., Greenville, SC.

September 2001 Vol. 47 Issue 9 45

TABLE 6EQUATIONS USED TO DETERMINE RATE OF

WOUND CLOSURE

Size (volume)

“Amount closed”

“Rate of closure perweek”

“Percentage of woundclosure”

“Rate of wound closureper week” (percentage)

Length x Width x Depth (cm)

Size at Start (cm3) – Size at X*-weeks (cm3)

(Size at Start – Size at X weeks)X

(Size at Start – Size at X-weeks)Size at Start

Percentage of Wound ClosureX

* X = 3 weeks or the number of weeks in the study.

Page 9: “Constant Force Technology” versus Low-Air-Loss ... Stage II pressure ulcer, including hospitalization, was $1,119 ±$4,234. The mean cost to heal a Stage III or IV ulcer, including

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46 OstomyWound Management