RESUMO
OBJECTIVE: To evaluate the efficacy, tolerance and acceptability an innovative two-layer system (KTwo; Laboratoires URGO) versus an established four-layer bandage system (Profore; Smith & Nephew) in the local management of venous leg ulcers. METHOD: A non-inferiority European randomised controlled trial, conducted in 37 centres, in three countries (France, U.K. and Germany), on patients presenting with venous leg ulcers (VLUs). Participants were adult, non-immunosuppressed patients who presented with non-infected, non-malignant leg ulcers, predominantly of venous origin (ABPI > 0.8), with a surface area of 2-50 cm2 and duration 1-24 months. Patients were followed-up every 2 weeks for a period of 12 weeks, or until full closure. Visits included a clinical examination, wound area tracings and photographic evidence. The primary endpoint was the percentage of leg ulcers healed after the 12 weeks, with secondary endpoints of relative wound area reduction (RWAR), absolute wound area reduction (AWAR) and the percentage of wounds with RWAR > or = 40%. RESULTS: In total, 187 patients were randomised to either the two-layer bandage (2LB, n=94) or four-layer bandage (4LB; n=93) system. The two groups were comparable,with regard to wound and patient characteristics, at baseline. By week 12, 44% of VLUs in the 2LB group and 39% in the 4LB group had healed (intention-to-treat [ITT] analysis). The per-protocol (PP) analysis showed that complete wound closure was obtained in 48% and 38% of the 2LB and 4LB groups, respectively. A non-inferiority margin within -10% is considered as demonstrating a 95% and 97.5% confidence interval (p = 0.001). The AWAR was 6.6 cm2 in the test and 4.9 cm2 in the control group. The percentage of wounds with a RWAR > OR =40% was 47% and 44% for the 2LB and 4LB systems, respectively. Pain between dressing changes was reported in 27% of the test and 40% of the control group, and the incidence of adverse events was 17% and 25%, respectively. The 2LB compression system was considered to be significantly easier to apply than the 4LB (p = 0.038). CONCLUSION: The 2LB system (KTwo) was not seen to be any less effective than a well-known 4LB system (Profore) in the management of VLUs. Furthermore, the 2LB system was considered to be easier to apply, representing an alternative to the conventional treatment with 4LB currently available. DECLARATION OF INTEREST: This study was sponsored by a grant from Laboratoires URGO, manufacturers of KTwo. S. Bohbot and A. Sauvadet are employees of Laboratoires Urgo. S. Meaume has received monetary compensation as a speaker for Laboratoires Urgo. Data management and statistical analyses were conducted by Vertical (J. C. Kerihuel; Paris, France).
