Randomized trial of two foam dressings in the management of chronic venous ulceration

Abstract

A multicenter prospective randomized clinical trial was undertaken to compare two foam dressings (Allevyn Hydrocellular, Smith & Nephew and Mepilex, Molnlycke Health Care AB) in the management of chronic venous leg ulceration. Patients were also randomized to two compression bandage systems (4-layer vs. cohesive short stretch) as a factorial design. Those with causes of ulceration other than venous disease were excluded. In all, 156 patients met the entry criteria and were randomized from the 12 clinical centers with a median (range) ulcer size of 4.33 (0.33-123.10) cm(2). After 24 weeks a total of 100 (64.1%) patients had complete ulcer closure, 46 (29.5%) had withdrawn from the trial, nine (5.8%) remained unhealed and one patient died. Of the patients randomized to Mepilex, 50/75 (66.7%) had complete ulcer healing compared with 50/81 (61.7%) on Allevyn. The hazard ratio for healing after adjustment for bandage type and trial center was 1.48 (95% C.I. 0.87-2.54, p=0.15), which only marginally changed following adjustment for baseline variables, neither of which achieved statistical significance (p=0.16). Withdrawal rates were similar between groups (23, 30.7% Mepilex vs. 23, 28.4% Allevyn). Pain improved following treatment with both dressings (p<0.001), but with no difference between dressings.