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Randomized trial of two foam dressings in the management of chronic venous ulceration
Author(s) -
Franks Peter J.,
Moody Marion,
Moffatt Christine J.,
Hiskett Gill,
Gatto Pauline,
Davies Claire,
Furlong Winnie T.,
Barrow Erica,
Thomas Hazel
Publication year - 2007
Publication title -
wound repair and regeneration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.847
H-Index - 109
eISSN - 1524-475X
pISSN - 1067-1927
DOI - 10.1111/j.1524-475x.2007.00205.x
Subject(s) - medicine , bandage , randomized controlled trial , venous leg ulcer , surgery , hazard ratio , varicose ulcer , confidence interval
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 After 24 weeks a total of 100 (64.1%) patients had complete ulcer closure, 46 (29.5%) had withdrawn from the trial, nine (5.8%) remained unhealed and one patient died.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.