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

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ResultsSayag et al., 1996 49Comparison: Dextranomer vs. Calcium alginate(Debrisan) (Algoseril ® )Mean baseline area (cm 2 ): 16.1 (12.5 SD) 20.1 (12.9 SD)Sample size (N): 45 47No. of wounds reduced by40–100% in area: 19 35 4.00 (1.65, 9.65)No. of wounds reduced by> 75% in area: 6 15 3.05 (1.06, 8.76)Wound type:Follow-up time:Pressure soresUntil the wound reached 40% of its originalsize or on completion of 8 weeks’ treatmentPalmieri, 1992 50Comparison: Dextranomer vs. Collagen sponge(Debrisan)Mean baseline area (cm 2 ): Not stated Not statedSample size (N): 12 12Mean time to healing (days): 47 20 27Wound type: Pressure soresFollow-up time: Until all wound had healedAlgosteril ® , Les Laboratories Brothier0.01 0.1 1 10 100 OR(95% CI)ES–40 –20 0 20 40 (95% CI)Favours dextranomer Favours alternative dressingFIGURE 7 Calcium alginate and collagen sponge dressings compared with topical dextranomer for the healing of pressure sores18(Granuflex and Comfeel) and either a polyhydroxyethylmethacrylate, 66 or an amino acidcopolymer membrane, 67 (Figure 11; appendix 7,Table 14). Similarly there was no statistical differencebetween a semipermeable adhesive dressingand a polyurethane foam dressing 68 (Figure 10;appendix 7, Table 14 ).Treatments for leg ulcersThree trials evaluated primary dressings ortopical agents in the treatment of arterial legulcers: hydrocolloid dressing versus a lowadherent dressing, 69 mononuclear culturedcells versus placebo, 70 and ketanserin versusvehicle alone. 71Twelve trials studied patients with ulcers ofdiverse aetiologies without presenting the resultsaccording to the leg ulcer aetiology. Three trials(seven reports) compared a ‘modern’ dressingwith a traditional dressing, five trials (six reports)compared topical agents with a placebo or traditionaltreatments, three trials were head-to-headcomparisons of dressings, and one trial compareda topical agent with a dressing.Fifty-one trials of dressings and topical agents forvenous leg ulcers were identified. Eighteen trialscompared dressings with traditional treatments(normally gauze-type dressings). Ten trials comparedtwo or more dressings, and seventeen compareda topical preparation with a control. Threetrials compared dressings with topical preparationsand three reported head-to-head comparisons oftopical agents.The majority of trials had methodological weaknesses(appendix 5, Table 6). Fewer than 9% ofstudies reported an a priori estimate of the numberof participants required for the trial to have sufficientpower to detect a clinical difference as statisticallysignificant. The median number of woundsrecruited to a trial was 48.5 (range, 9–233). Blindingof investigators at outcome assessment was reportedin fewer than 7% of trials. One or more patientcharacteristics were recorded by treatment groupin 36 out of 48 (75%) studies, but wound size atbaseline (by group) was reported in only 30 of the48 (62%) studies. Withdrawals occurred in mosttrials and the number and cause were recorded bygroup in 46% of trials where it was appropriate,but only 18% performed an ITT analysis. Sixty-twoper cent described relevant inclusion criteria, but
Health Technology Assessment 1999; Vol. 3: No. 17 (Pt 2)Alm et al., 1989 51Comparison: Traditional vs. Hydrocolloid (Comfeel ® )Mean baseline area (cm 2 ): 2.44 2.02Sample size (N): 31 25No. of wounds healed (n/N): 5/31 (16%) 11/25 (44%) 4.09 (1.18, 14.14)Median absolute reductionin wound area (cm 2 ): 1.8 2.0 0.2% reduction in wound area: 68 100 32Traditional therapy: Saline gauzeWound type: Pressure soresFollow-up time: 6 weeksBarrois, 1993; 52 Huchon, 1992 53Comparison: Traditional vs. Hydrocolloid(Granuflexstandard)Mean baseline area (cm 2 ): Not stated Not statedSample size (N): 38 38No. of wounds healed (n/N): 9/38 (24%) 10/38 (26%) 1.15 (0.41, 3.26)% reduction in wound area/week: 7 10 3.00Traditional therapy: Tulle gauze impregnated with povidone-iodineWound type: Pressure soresFollow-up time: 8 weeksColwell et al., 1993 54Comparison: Traditional vs. Hydrocolloid (Granuflex)Mean baseline volume (cm 3 ): 2.4 2.3Sample size (N): 49 48No. of wounds healed (n/N): 1/49 (3%) 11/48 (23%) 14.27 (1.76, 115.56)Traditional therapy: Saline-soaked gauzeWound type: Pressure sores (grade II or III)Follow-up time: 8 weeksGorse & Messner, 1987 56Comparison: Traditional vs. HydrocolloidMean baseline area (cm 2 ): Not stated Not statedSample size (N): 52 (25 patients) 76 (27 patients)No. of wounds healed (n/N): 26/52 (50%) 54/76 (71%) 2.46 (1.18, 5.12)Mean time to healing (days): 10 8.7 1.30Traditional therapy: Wet-to-dry dressings and Dakin’s solutionWound type: Pressure sores (grade II, III or IV)Follow-up time: 75 daysXakellis & Chrischilles, 1992 55Comparison: Traditional vs. HydrocolloidMedian baseline area (cm 2 ): 0.38 0.66Sample size (N): 21 18No. of wounds healed (n/N): 18/21 (86%) 16/18 (89%) 1.33 (0.20, 9.02)Median time to healing (days): 11 9 2Traditional therapy: Saline gauzeWound type: Pressure sores (grade II or III)Follow-up time: 75 daysPooled estimate (fixed-effects model)Comparison: Traditional vs. HydrocolloidTotal no. of wounds healed (n/N): 59/191 (31%) 102/205 (50%) 2.57 (1.58, 4.18)χ 2 = 5.76; df = 4; z = 3.87; p = 0.2180.01 0.1 1 10 100 OR(95% CI)ES–4 –2 0 2 4 (95% CI)–40 –20 0 20 40ES(95% CI)Comfeel ® , Coloplast LtdFavours traditionalFavours hydrocolloidFIGURE 8 Hydrocolloid dressings compared with traditional treatments for the healing of pressure sores19
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Page 10 and 11: Executive summarythan either an alg
Page 12 and 13: Introduction2sores) or due to under
Page 14 and 15: Introduction4healing rates are low
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
Page 30 and 31: ResultsOleske et al., 1986 57Compar
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Page 34 and 35: ResultsMoffatt et al., 1992 88Compa
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Page 40 and 41: ResultsZuccarelli, 1993 113Comparis
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Page 46 and 47: ResultsTosti & Veronesi, 1983 132Co
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Appendix 11124TABLE 27 Summary of c
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Appendix 11TABLE 28 Differences in
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HTA Commissioning BoardCurrent memb
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