Dressings and Topical Agents for Chronic Wounds - NIHR Health ...

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ResultsZuccarelli, 1993 113Comparison: Foam (Allevyn) vs. Hydrocolloid (Granuflex)Mean baseline area (cm 2 ): 9.8 6.9Sample size (N): 19 19No. of wounds healed (n/N): 9/19 9/19 1.0 (0.28, 3.58)% of wounds healed: 47 47Wound type: Venous leg ulcersFollow-up time: 12 weeksBowszyc et al., 1993 114Comparison: Foam vs. Hydrocolloid(Lyofoam)(Comfeel)Median baseline area (cm 2 ): 3.01 3.05Sample size (N): 40 40No. of wounds healed (n/N): 24/40 24/40 1.0 (0.4, 2.4)% of wounds healed: 60 60Wound type: Venous leg ulcersFollow-up time: 16 weeksPooled estimate (fixed-effects model)Comparison: Foam vs. HydrocolloidTotal no. of wounds healed (n/N): 33/59 (56%) 33/59 (56%) 1.00 (0.48, 2.08)χ 2 = 0.00; df = 1; z = 0.00; p = 10.01 0.1 1 10 100 OR(95% CI)Favours foamFavours hydrocolloidFIGURE 16 Hydrocolloid compared with foam dressing for venous leg ulcer30for the generalisability of the results to all leg ulcerpatients treated in the UK.Tsakayannis and co-workers 122 compared sucralfateointment (a substance capable of binding basicfibroblast growth factor, and hence preventingits breakdown), with the cream vehicle aloneand found no difference in the proportion ofulcers healed.Werner-Schlenka and co-workers 120,121 reportedtwo trials that evaluated topical iloprost. Onetrial 121 compared two solutions of iloprost (0.0005%and 0.002%), and in the other 120 patients receivedeither 10 µg/ml (0.001%) for the first 3 days,increasing to 40 µg/ml (0.004%) for the restof the study period, or placebo. There was nosignificant difference in either the proportion ofulcers healed or the reduction in ulcer area overthe trial period (Figure 20; appendix 10, Table 23).Bishop and co-workers 125 compared a tripeptidecopper complex cream with silver sulphadiazineand a control of vehicle cream alone. He foundno difference in the reduction in wound areawith the copper cream but there was a reductionin wound area with the silver sulphadiazinecompared with both the control and thecopper complex (appendix 10, Table 23).Topical agents versus placeboThree trials (five reports) reported comparisonsbetween growth factors and a placebo. 126–130None found a significant difference for eitherthe reduction in ulcer area or proportion ofulcers healed during the trial period. The trialsby Freak and co-workers 127,128 and Rasmussenand co-workers 126,129 were similar in that they bothcompared three dose regimens of biosynthetichuman growth hormone and placebo. Pooling theresults from these two trials (using a fixed effectmodel) for the concentrations used (0.17 IU/mlversus placebo, 1.0 IU/ml versus placebo, and11.2 IU/ml versus placebo) found no significantbenefit for using the growth hormone at any concentration.The study by Falanga and co-workers 130
Health Technology Assessment 1999; Vol. 3: No. 17 (Pt 2)Passarini et al., 1982 115Comparison: Traditional vs. Hyaluronic acidMean baseline area (cm 2 ): Not stated Not statedSample size (N): 25 23Mean % reduction in wound area: 44 78 34Traditional therapy: Various treatmentsWound type: Venous leg ulcersFollow-up time: 20 daysGalasso et al., 1978 116Comparison: Traditional vs. Hyaluronic acidMedian baseline area (cm 2 ): Not stated Not statedSample size (N): 35 27No. of wounds healed (n/N): 29/35 (83%) 21/27 (78%) 0.72 (0.2, 2.56)Traditional therapy: GauzeWound type: Venous leg ulcersFollow-up time: Unclear0.01 0.1 1 10 100 OR(95% CI)–40 –20 0 20 40 ES(95% CI)Favours traditionalFavours hyaluronic acidFIGURE 17 Hyaluronic acid compared with traditional dressings for venous leg ulcerscompared one dose of human recombinantepidermal growth factor with placebo (Figure 21;appendix 10, Table 24).Topical agents versus dressingsThree trials compared dressings withtopical preparations for venous ulcers.The comparisons were:• cryopreserved cultured allografts versushydrocolloid dressing 131• daily antiseptic versus collagen 132• magnesium sulphate paste versushydrocolloid. 133Teepe and co-workers 131 compared a hydrocolloiddressing with cryopreserved cultured allografts.There was no difference in the proportion ofulcers healed, but cryopreserved cultured allograftswere associated with a greater reduction in thepercentage area of wound healed (Figure 22;appendix 10, Table 25).A collagen dressing healed a higher proportionof ulcers than treatment with a daily applicationof antiseptic. 132 There was no significant differencein the proportion of ulcers healed in acomparison between magnesium sulphatepaste and a hydrocolloid. 133 The rate of ulcerhealing expressed as area epithelialised per daywas reported as significantly higher with thehydrocolloid dressing, but baseline comparabilityfor ulcer size at randomisation could not beestimated and the presence of underlying biascannot therefore be excluded (Figure 22;appendix 10, Table 25).Topical agent versus topical agentOnly three trials reported head-to-headcomparisons of topical agents. Thecomparisons were:• buffered acidifying ointment versus ointment 134• amino acid solution (two concentrations)versus saline (two concentrations) 135,136• copper versus silver. 125Wilson and co-workers 134 compared a bufferedacidifying ointment with emulsifying ointmentand found no difference in the numbers ofulcers healed. There was a higher healing rate(expressed as percentage area healed per day)in the buffered ointment group, but this wasconfounded by the inequalities in baseline ulcerarea, which was biased towards the bufferedointment (appendix 10, Table 26).31
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Page 22 and 23: ResultsMacfie & McMahon, 1980 34Com
Page 24 and 25: ResultsLe Vasseur & Helme, 1991 40C
Page 26 and 27: ResultsMustoe et al., 1994 43Compar
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