Randomized trial of two foam dressings in the management of chronic venous ulceration.
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 After 24 weeks a total of 100 (64.1%) patients had complete ulcer closure, 46 (29.5%) had withdrawn from the trial, nine (5.8%) remained unhealed and one patient died.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.
Franks
Peter J
PJ
Centre for Research & Implementation of Clinical Practice, Faculty of Health & Human Sciences, Thames Valley University, London, United Kingdom. peter.franks@tvu.ac.uk
Moody
Marion
M
Moffatt
Christine J
CJ
Hiskett
Gill
G
Gatto
Pauline
P
Davies
Claire
C
Furlong
Winnie T
WT
Barrow
Erica
E
Thomas
Hazel
H
D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009779:Occlusive Dressings; D010146:Pain / Q000517:prevention & control; D010147:Pain Measurement; D011140:Polyurethanes / Q000627:therapeutic use; D011446:Prospective Studies; D014647:Varicose Ulcer / Q000628:therapy*; D014945:Wound Healing
D011140:Polyurethanes; C081143:allevyn