Randomised Trial Comparing Two Four-Layer Bandage Systems in the Management of Chronic Leg Ulceration

Abstract

Objective: To compare a new four-layer bandage system (Profore) with the original 4LB in the closure of chronic leg ulceration. Design: Prospective randomised stratified parallel-groups open trial. Methods: Patients newly presenting to community leg ulcer services with chronic leg ulceration were screened for inclusion in this trial. Patients with arterial disease (ankle brachial pressure index <0.8) and causes of ulceration other than venous disease were excluded. In patients with bilateral ulceration, the limb with the larger area of ulceration was studied. The ulcer was dressed with a simple low-adherent dressing and all bandages were changed weekly unless required more frequently. Patients were randomised to receive either the original four-layer bandage or the newer system (Profore). Results: In all 233 patients were randomised, of whom 232 attended at least one follow-up visit (115 original, 117 Profore). At 12 weeks complete healing of the ulcerated limb, analysed by ‘intention-to-treat’ was 60% using the original 4LB compared with 72% using Profore. The difference of 11.8% (95% confidence interval (CI) −0.3% to 23.9%) had largely disappeared after 24 weeks, with 73% healed using the original 4LB and 76% using Profore, a difference of 3.0% (95% CI −8.2% to 14.2%). After 24 weeks of treatment the Kaplan-Meier estimate of complete healing was 82% using the original system and 84% using the Profore system. Overall, there was a higher healing rate for patients on Profore (hazard ratio = 1.18, 95% CI 0.87 to 1.59), but this did not achieve statistical significance ( p = 0.28). Conclusion: Ulcer healing using the newer Profore system is as good as with the original four-layer system.