Systematic review of dressings and topical agents for surgical wounds healing by secondary intention

Systematic review

Systematic review of dressings and topical agents for surgicalwounds healing by secondary intention

H. Vermeulen1, D. T. Ubbink1,2, A. Goossens2, R. de Vos2 and D. A. Legemate1

1Departments of Surgery and 2Clinical Epidemiology and Biostatistics, Academic Medical Centre, Amsterdam, The Netherlands.Correspondence to: Dr H. Vermeulen, Department of Surgery, G4-233, Academic Medical Centre, Meibergdreef 9, PO Box 22700, 1100 DE Amsterdam,The Netherlands (e-mail: [email protected])

Background: The best dressing for postoperative wounds healing by secondary intention is unknown.Methods: A systematic review was conducted to assess the effectiveness of dressings and topical agentson such wounds. Main endpoints were wound healing, pain, patient satisfaction, costs and hospital stay.Systematic methodological appraisal and data extraction were performed by independent reviewers.Results: Fourteen reports of 13 randomized clinical trials on dressings or topical agents (gauze, foam,bead, alginate and hydrocolloid dressing) for postoperative wounds healing by secondary intention wereidentified; they were of weak methodological quality. In general, no statistically significant differencesin wound healing were found for various dressing comparisons (11 of 13 trials). Patients experiencedsignificantly more pain (four of six trials) and were less satisfied when gauze was used (three of six trials).Gauze was inexpensive, but its use was associated with significantly more nursing time than dressingwith foam (two of three trials). No substantial differences in hospital stay were found (four of five trials).Conclusions: Only small, poor-quality trials exist, rendering the evidence insufficient. Foam is beststudied as an alternative to gauze and appears to be preferable in terms of pain reduction, patientsatisfaction and nursing time.

Paper accepted 19 February 2005Published online in Wiley InterScience (www.bjs.co.uk). DOI: 10.1002/bjs.5055

Introduction

Surgical wounds healing by secondary intention aregiven local care, for example maintaining a moist woundenvironment to foster healing1. Such secondary healingtends to occurs when operations involve body cavitiescontaining infected, necrotic or contaminated tissue. Incolorectal surgery, for example, the accepted infection rateis 10–30 per cent2. Concurrent infection is a known riskfactor for abdominal wound dehiscence3.

There are many types of dressings (gauze, bandagesetc.) and topical agents (antiseptics, enzymes etc.) availablefor local wound management. The ideal dressing forwounds healing by secondary intention has several features,including an ability to absorb and contain exudate withoutleakage, impermeability to water and bacteria, lack ofparticulate contaminants that may be left in the wound,and avoidance of wound trauma on dressing removal4.Poorly healing wounds are also often treated with topicalagents, such as hydrogels and topical antimicrobials5–7.The choice of dressings and topical agents is rarely based

on a firm rationale8, being generally influenced by personalpreference and marketing activities.

This review identifies and summarizes the evidence forthe effectiveness of different dressings and topical agents inthe management of surgical wounds healing by secondaryintention, irrespective of whether the secondary intentionwas planned or unplanned. A more detailed review has beenpublished in the Cochrane Database of Systematic Reviews9.

Methods

All randomized clinical trials (RCTs) evaluating the effectsof dressings or topical agents for surgical wounds healingby secondary intention were eligible, if the trial reportedwound healing. Owing to their susceptibility to bias, non-randomized studies were included only in the absence ofRCTs, in agreement with the CONSORT statement10.

Relevant reports were searched from the CochraneCentral Register of Controlled Trials, Cochrane WoundsGroup Specialized Trials Register, Medline, Embase and

Copyright 2005 British Journal of Surgery Society Ltd British Journal of Surgery 2005; 92: 665–672Published by John Wiley & Sons Ltd

666 H. Vermeulen, D. T. Ubbink, A. Goossens, R. de Vos and D. A. Legemate

Cinahl databases in March 2002. The search was notlimited by language or publication status. Two reviewers(H.V. and A.G.) independently screened the titles andabstracts of references identified by the search for potentialrelevance and design. In cases of disagreement or doubta third reviewer was consulted (D.T.U.). Full versionsof articles were obtained and checked independently toidentify those that met the inclusion criteria. Again,disagreement was resolved by discussion and, if necessary, athird reviewer was consulted. Trials published in duplicatewere included only once (Fig. 1).

The methodological quality of each trial was thenassessed systematically and independently, with the useof quality questionnaires from the Dutch Quality Institutefor Health Care Improvement/Dutch Cochrane Centreon factors relating to internal and external validity11.Details of the studies found were extracted and summarizedindependently by two reviewers using a standard dataextraction sheet11. Again, disagreement was resolved bydiscussion, if necessary by consulting a third reviewer.

Quantitative data were entered into the CochraneRevMan 4·2 software and analyzed using MetaView

(Cochrane Collaboration, Oxford, UK). For each outcome,a meta-analysis was planned if statistical heterogeneity(I2) was below 60 per cent. For continuous outcomesthe weighted mean differences (WMDs) or standardizedmean differences were calculated when appropriate andfor dichotomous outcomes the relative risk (RR) wascalculated12.

Results

Study descriptions

Fourteen reports on 13 RCTs were identified as having metthe inclusion criteria (Table 1). These trials were publishedbetween 1979 and 2000. Study sizes ranged from 20 to80 patients and a total of 611 patients were included. Sixtrials recruited patients with pilonidal sinuses after incisionor excision15–17,21,22,25, five described patients with

CochraneCentralRegister ofControlledTrials toMarch2002

CochraneWoundsGroupSpecializedTrialsRegister toMarch 2002

Medlineto March2002

Embase toMarch 2002

Cinahl toMarch2002

581 potential titles identified

Two reviewers independently readthe abstracts and applied theinclusion criteria

14 reports on 13 trials identifiedfor systematic review

Exclusion criteriaNo randomized clinical trialPrimary healingNo surgical woundsNo topical treatmentNo adult populationWound healing not measured as primary endpoint.Other wounds (skin graft, nail ablation)

Fig. 1 Flow chart of included trials

Copyright 2005 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2005; 92: 665–672Published by John Wiley & Sons Ltd

Dressings and topical agents for surgical wounds 667

Table 1 Characteristics and methodological quality of included studies

Quality

Reference Wounds Wound care n Endpoints 1 2 3 4 5 6 7

Foam versus gauze13,14 Perineal wounds Silicone foam (Silastic) versus gauze

with mercury chloride antisepticsolution

50 Wound healingPainCostsNursing visitsHospital stay

+ ? + + − + +

15 Pilonidal sinus wounds Silicone foam (Silastic) versus gauzewith 0·5% chlorhexidine solution(Hibitane)

80 Wound healingPatient satisfactionNursing visitsHospital stay

+ ? + + ? ? ?

16 Pilonidal sinus wounds andabscesses

Silicone foam (Silastic) versus gauzewith sodium hypochlorite (Eusol)

75 Wound healingHospital stay

+ ? + ? ? + +

17 Pilonidal sinus wounds Silicone foam (Silastic) versus gauzewith choramine

33 Wound healingPatient satisfactionNursing visits

+ + + + ? ? ?

18 Laparotomy wounds andabscesses

Polyurethane foam (Cutinova) versusgauze with unknown fluid

43 Wound healingPain

+ ? ? + ? + ?

Beads versus gauze19 Complicated surgical

abdominal woundsDextranomer polysaccharide beads

(Debrisan) versus gauze withsodium hypochlorite (Eusol)

20 Wound healingCostsHospital stay

+ ? + + + + +

Alginate versus gauze20 Complicated surgical

abdominal woundsCalcium alginate (Sorbsan) versus

gauze with sodium hypochlorite orgauze

36 Wound healingPainPatient satisfactionCosts

+ + + + + − ?

21 Pilonidal sinus wounds Calcium alginate versus gauze withpovidone–iodine solution

70 Wound healingPainPatient satisfaction

+ ? ? ? ? ? ?

Hydrocolloids versus gauze22 Pilonidal sinus wounds Hydrocolloids Comfeel and

Varihesive versus gauze withpovidone–iodine solution

38 Wound healingPainExudateCostsPatient satisfaction

+ ? + + − + +

Aloe vera gauze versus gauze23 Complicated abdominal

(gynaecological) surgicalwounds

Aloe vera gel gauze versus Gauze 40 Wound healing + + − ? − + +

Foam versus beads24 Complicated surgical

abdominal woundsSilicone foam (Silastic) dressing

versus Dextranomer polysaccharidebeads (Debrisan)

50 Wound healingPainComplications

+ ? + + ? + +

Foam versus alginate25 Pilonidal sinus wounds Polyurethane foam (Allevyn) versus

calcium sodium alginate (Kaltostat)20 Wound healing

Patient satisfactionExudate

+ ? − + − − +

Plaster cast versus elastic compression26 Below-knee amputation

woundsElastic compression bandage versus

Plaster cast socket56 Wound healing

Hospital stay+ ? + + ? + +

1, randomization; 2, Allocation concealment; 3, sufficient follow-up; 4, intention-to-treat analysis; 5, blinding; 6, group comparability at baseline; 7,similar treatment apart from intervention; +, yes; −, no; ?, too little information.Silastic: Dow Corning, Midland, Michigan, U.S.A. Hibitane: Zeneca Ltd, Macclesfield, Cheshire, UK. Cutinova: Smith & Nephew, Hull, UK.Debrisan: Pharmacia & Upjohn, Kalamazoo, MI, USA. Sorbsan: Bertek Pharmaceuticals, Morgantown, WV, USA. Comfeel: Coloplast, Humlebaek,Denmark. Varihesive: Convatec, Skillman, New Jersey, USA. Allevyn: Smith & Nephew, Hull, UK. Kaltostat: Convatec, Skillman, New Jersey, USA.



postoperative abdominal wound breakdown18–20,23,24, onestudied patients with perineal wounds after excision ofthe rectum13, and one included patients with below-kneeamputation wounds25.

All papers reported wound healing, except for onecost–benefit trial14, which was an economic analysis ofthe data from Macfie and Mahon13. Pain was measured indifferent ways. No trial measured quality of life, but sixtrials measured patient satisfaction15,17,20–22,25. Costs weremeasured in four trials and hospital stay in five13,15,16,19,26.

Methodological quality

Table 1 gives an overview of the characteristics and qualityof the included studies. In all 13 trials the authors statedthat allocation was random, for example by means of sealedenvelopes or drawn lots, but the method of generating therandomization sequence was not always clear. In nine ofthe 13 trials, the proportion of patients who completedfollow-up was over 80 per cent, and an intention-to-treatanalysis was used in ten. Blinding was poorly reported. Inonly two trials were the outcome assessors blinded19,20. Ineight studies both groups were comparable at baseline, andeight trials avoided co-interventions. No trial reported apriori sample size calculation.

Outcome variables

Table 2 summarizes the results of the comparisons betweenvarious dressings.

Wound healingWound healing was reported in all 13 RCTs, but it wasmeasured in different ways, such as time to complete heal-ing, wound area or volume reduction, and proportions ofwounds healed within the follow-up period. There wereno statistically significant differences in healing in 11 of13 trials. Four reports presented five comparisons between

gauze and foam dressings (Fig. 2), but showed no significantdifferences in wound healing time13,15,16,17. The studies ofWalker16 and Eldrup17 showed no standard deviations.While a single small trial of aloe vera supplementation ver-sus gauze suggested delayed healing with the former, theresults of this trial were hard to interpret because of a largedifferential loss to follow-up23. In one study a plaster castapplied to an amputation stump accelerated wound heal-ing compared with elastic compression (WMD − 25·60(95 per cent confidence interval (c.i.) − 49·08 to − 2·12)days)26.

PainPain was reported in six of the 13 RCTs13,18,20,21,22,24, butit was measured in different ways, such as the need foranalgesia, and on a four-, ten- or 100-point visual analoguescale (VAS). In all of the five trials comparing gauze with amodern dressing, patients dressed with gauze experiencedsignificantly more pain. Macfie and McMahon13 found aRR of 0·27 (95 per cent c.i. 0·10 to 0·69) in respect of theneed for analgesia in the group treated with foam. Meyer18

found a significantly higher ten-point VAS pain score inthe gauze group than in the foam group (mean 1·82 versus0·86; P < 0·050). Cannavo et al.20 recorded a significantlylower maximum pain score on a ten-point VAS using algi-nate dressing than with gauze (WMD − 2·7 (95 per centc.i. − 3·28 to − 2·12)). Guillotreau et al.21 also found a sig-nificant difference (P < 0·001) on a VAS scale in favour ofalginate rope, which caused no pain, compared with gauze.Viciano22 measured pain per dressing change using a visualanalogue scale (VAS) and found pain in the hydrocolloidgroups was significantly lower than in the gauze groupduring the first 4 weeks (P < 0·05).

Patient satisfactionPatient satisfaction was reported in six of the 13 RCTs;this was measured in various ways, such as a four- or

Table 2 Comparisons between dressings for all endpoints

Gauzeversusfoam

Gauzeversusbead

Gauzeversus

alginate

Gauzeversus

hydrocolloid

Gauzeversus gauze

Aloe vera

Foamversusbead

Foamversus

alginate

Plasterversus elasticcompression

Outcome (5 trials) (1 trial) (2 trials) (1 trial) (1 trial) (1 trial) (1 trial) (1 trial)Wound healing 0 0 0 0 0 0 0 0 0 + 0 0 +Pain ++ ++ + 0Exudate absorption + 0Complication + 0Patient satisfaction 0+ ++ 0 0Costs 0 0 0 0Nursing time 0++ (+)Hospital stay 0 0 0 (0) 0 +

+, Significant positive effect; 0, no significant effect; pooled effect is shown in parentheses.



Foam Gauze

−9·20 (−24·67, 6·27)

8·50 (−1·52, 18·52)

Not estimable

Not estimableNot estimable

0·0

0·00·0

44·2

55·8

Reference Woundtype

nHealingtime (days)

Healingtime (days)*

WMD (fixed) Weight(%)

WMD (fixed)†n

1625212036

118

1725171744

120

1713161615

P

A

PS

PS

PS

33·00(0·00)

33·00(0·00)69·50(36·50)

57·70(19·60)39·60(0·00)

31·00(0·00)

30·00(0·00)39·80(0·00)

60·30(15·00)

66·20(28·10)

−100 −50 0 50 100

Favours foam Favours gauze

Total

Fig. 2 Forest plot of trials comparing gauze and foam dressings with respect to wound healing times. *Values are mean(s.d.); †values inparentheses are 95 per cent confidence intervals (c.i.). Plot shows weighted mean differences (WMDs) with 95 per cent c.i. PS,pilonidal sinus wounds; P, perineal wounds; A, abscesses. Test for heterogeneity: χ2 = 3·54, 1 d.f., P = 0·06, I2 = 71·8 per cent. Apooled effect is not shown because heterogeneity was considerable. Test for overall effect: Z = 0·08, P = 0·94

Foam Gauze

−32·80 (−45·10, −20·50)−30·50 (−37·71, −23·29)

−31·09 (−37·31, −24·87)

Not estimable

25·5574·45

100

ReferenceWound

typenNo. of visits No. of visits* WMD (fixed)

Weight(%) WMD (fixed)†n

25 253618

77

4417

86

131517

60·30(15·00)66·20(28·10)

4·00(0·00)

69·50(36·50)57·70(19·60)4·00(0·00)

−100 −50 0 50 100


PPSPS

Total

Fig. 3 Forest plot of trials comparing gauze and foam dressings with respect to district nursing time. *Values are mean(s.d.); †values inparentheses are 95 per cent confidence intervals (c.i.). Plot shows weighted mean differences (WMDs) with 95 per cent c.i. P, perinealwounds; PS, pilonidal sinus wounds. Test for heterogeneity: χ2 = 0·10, 1 d.f., P = 0·75, I2 = 0 per cent. Test for overall effect:Z = 9·80, P < 0·001

ten-point VAS. In three of six trials, patients treated withgauze were less satisfied than those receiving alternativedressings. Williams et al.15 examined patient discomfortper dressing change and found the average degree of dis-comfort in a group using foam was significantly lower thanthat in a group using gauze (WMD − 1·5 (95 per cent c.i.0·63 to 2·37)). Cannavo et al.20 studied patient comfortduring dressing changes using a ten-point rating scale andfound significantly less satisfaction with antiseptic gauzesthan with alginate dressings (WMD − 1·50 (95 per centc.i. − 1·16 to − 1·84)). Eldrup17 merely stated that patientswere more comfortable with foam dressings without givingdata.

CostsCosts were reported in four of the 13 RCTs, but noreal cost-effectiveness analyses were conducted in thesestudies. The reported costs comprised material and non-material costs, in particular district nursing time. No trial

identified significant differences in costs. Culyer et al.14

reported overall costs per patient. Pure dressing costs forfoam were higher, but the non-material costs were lower.The total costs per patient demonstrated that foam wasless expensive than gauze. No statistical calculation wasperformed.

Nursing timeNursing time was reported in three of the 13 RCTs. In allthree the number of district nursing visits was measured.The use of gauze was associated with significantly morenursing time than foam in two of three trials. In twotrials gauze consumed significantly more nursing timethan foam13,15 (Fig. 3); the pooled WMD was − 31·09(95 per cent c.i. − 37·31 to − 24·87) visits. Eldrup17

reported no difference in nursing visits (a mean of four inboth groups), but as no standard deviation was publishedthese results could not be incorporated in the pooledeffect.



Foam Gauze

−0·50 (−9·44, 8·44)

1·20 (−2·96, 5·36)

0·90 (−2·87, 4·67)

17·81

82·19

0·000·00 Not estimable

Not estimable

100

ReferenceWound

typen

Hospitalstay (days)*

Hospitalstay (days)*

WMD (fixed) Weight WMD (fixed)†n

20212036

102

25171744

103

13161615

29·40(18·00)12·80(0·00)11·50(0·00)

8·50(12·30)

29·90(14·00)15·20(0·00)14·60(0·00)

7·30(6·20)

−10 −5 0 5 10


PPS

PSA

Total

Fig. 4 Forest plot of trials comparing gauze and foam dressings with respect to duration of hospital stay. *Values are mean(s.d.); †valuesin parentheses are 95 per cent confidence intervals (c.i.). Plot shows weighted mean differences (WMDs) with 95 per cent c.i. PS,pilonidal sinus wounds; P, perineal wounds; A, abscesses. Test for heterogeneity: χ2 = 0·11, 1 d.f., P = 0·74, I2 = 0 per cent. Test foroverall effect: Z = 0·47, P = 0·64

Length of hospital stayDuration of hospital stay was reported in five of the13 RCTs. Four that compared gauze to an alternativedressing showed no difference in length of hospital staybetween groups (Fig. 4); the WMD was 0·90 (95 per centc.i. − 2·87 to 4·67) days. The trial by Vigier et al.26 showeda shorter hospital stay after amputation when a plaster castwas applied, compared with elastic compression (WMD− 30·10 (95 per cent c.i. − 49·82 to − 10·38) days).

Other outcome variablesData on other secondary outcome measures, such asexudate, complications, morbidity and quality of life(generic or specific measures) were either not or only poorlyreported. Exudate leakage was recorded in two trials. Inone, leaked exudate on 14 occasions in 23 patients dressedwith hydrocolloid was said to be a consequence of poordressing adherence22; leakage was not reported in the gauzegroup. In the other25, there was no significant difference inleakage (no or slight leakage in 81 per cent with foam versus73 per cent with alginate; RR 1·11) or absorption capacity(good in 85 versus 86 per cent respectively; RR 0·99). Noraw data were given and so it was not possible to calculatea 95 per cent c.i. Regarding complications of the use ofdressings, Young and Wheeler24 stated that there wasno difference in complications between the groups in thetime taken for the disappearance of erythema, oedema andslough, but no data were provided. Viciano et al.22 reporteda significantly higher growth of pathogens in the gauzegroup as compared to the hydrocolloid group (P = 0·03).

Discussion

This systematic review of the presently available literaturemakes it clear that there is insufficient evidence to show that

the choice of dressing or topical agent affects the healingof surgical wounds by secondary intention, although gauzeappears to be associated with greater discomfort duringdressing changes and requires more nursing time thanfoam dressings.

Worldwide, all kinds of dressings and topical agents areused in this context and it is surprising that no large, high-quality RCTs have been published so far. The scarcityof high-level evidence also holds for the local care ofwounds of other causes, such as diabetes, arterial or venousinsufficiency, and pressure sores27–31. This lack of evidencemay partly explain the large number of wound care productsthat are available and the wide variety of opinion regardingtheir use. This thwarts uniformity, drains the hospitalbudget and hampers the expertise of professionals involvedin local wound care. Practice has become mainly expertbased because of this gap in the evidence-based body ofknowledge, as illustrated by the large number of tissueviability nurses nowadays.

Taken the various wound aetiologies and manycommercially available wound care products, a hugenumber of trials would be required for assessment onthe basis of individual aetiology or dressing; this is hardlyfeasible. Research must aim primarily at gathering evidenceabout the usefulness of groups of materials, categorized onthe basis of their alleged working mechanism. For instance,a large RCT is ongoing in the authors’ own hospital, aimedat comparing non-occlusive, gauze-based dressings withocclusive, non-gauze-based dressings in surgical patientswith open wounds. Results are expected to be availableearly in 2006.

Some limitations to the conclusions of this review arerelated to the nature of the available trials. First, the13 trials used numerous different interventions, controlsand endpoints. Second, the methodological quality of the



studies was disappointingly poor; most were underpoweredand so ran a great risk of failing to detect any clinicallyrelevant differences as statistically significant. Third,the reporting of secondary endpoints, such as pain, ispotentially biased in that these endpoints are more likelyto be reported if a statistically significant benefit is found.Furthermore, several of the studies report a large numberof different outcomes over several time points, therebyincreasing the likelihood of a Type I error, that is to sayfinding a significance that is spurious.

The nature of a systematic review is to summarize orpool data from several, often small, trials to make anoverall conclusion or effect estimate. Replication studiesare needed as well as standards (validated scales) to measurewound healing (for example primarily expressed as timeto complete healing and secondarily expressed both asa relative and absolute change in wound surface area),pain (for instance on a ten-point VAS), satisfaction andcosts. To avoid the methodological flaws of the currentlyavailable individual trials, future work should adhere tothe CONSORT statement10, include measures to helpdemonstrate comparability of treatment groups at baseline(or adjust for differences), be of sufficient power to detecttrue treatment effects, use true randomization (computer-generated codes) with allocation concealment, and haveblinded outcome assessment by the effect reviewer.

In conclusion, evidence about care of postoperativewounds is scarce. Foam seems preferable to gauze interms of discomfort during dressing changes and nursingtime required. Large and well designed trials to enable anevidence-based choice about the best dressing are needed.

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Systematic review of dressings and topical agents for surgical wounds healing by secondary intention