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Randomized clinical trial and economic analysis of four layer compression bandaging for venous ulcers
O'Brien JF, Grace PA, Perry IJ, Hannigan A, Clarke-Moloney M, Burke PE
The British Journal of Surgery 2003 Jul;90(7):794-798
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The aim of this study was to compare the cost-effectiveness of four-layer compression bandaging for venous leg ulcers with that of other available treatments. METHODS: In this pragmatic trial, 200 patients with a venous leg ulcer were randomized either to four-layer bandaging (intervention group; n = 100) or to continue their usual system of care (control group; n = 100). The follow-up for each patient was 12 weeks. Analysis was by intention to treat; the main outcome measures were time to healing and cost to the health board per leg healed. RESULTS: Baseline characteristics were well matched in the two groups. The Kaplan-Meier estimate of the healing rate at 3 months was 54% with four-layer bandaging and 34% in the control group. Throughout the 3 months, four-layer bandaging healed leg ulcers significantly earlier (p = 0.006). There was a significant reduction in the median cost per leg healed with four-layer bandaging (Euro 210 versus Euro 234; p = 0.040). CONCLUSION: Four-layer bandaging is currently the most effective method of treating venous leg ulcers in a community setting.

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