Objective: To evaluate the efficacy, tolerance and acceptability of an innovative two-layer Dual Compression System bandage system (DCS*) versus an established four-layer bandage system (4LB**) in the local management of venous leg ulcers (VLUs). The DCS is designed to provide therapeutic compression whether the patient is ambulatory or nonambulatory.
Method: A non-inferiority European randomised controlled trial conducted in 37 centres, on patients presenting with VLUs. Participants were adult, non-immunosuppressed patients presenting with non-infected, non-malignant leg ulcers, predominantly of venous origin (ABPI > 0.8), with a surface area of 2–50cm2 and duration 1–24 months. Patients were followed-up every 2 weeks for 12 weeks, or until full closure. The primary endpoint was percentage of leg ulcers healed after 12 weeks, with secondary endpoints of relative wound area reduction (RWAR), absolute wound area reduction (AWAR) and the percentage of wounds with RWAR ≥ 40%.
Results: 187 patients were randomised to either the DCS group (n=94) or 4LB group (n=93). At baseline, both groups were comparable, when considering wound and patient characteristics. By week 12, 44.1% of VLUs in the DCS group had healed versus 38.7% in the 4LB group. Complete wound closure was obtained in 48% and 38% of the DCS and 4LB groups, respectively. The AWAR was 6.6cm2 in DCS group and 4.9cm2 in 4LB group. The percentage of wounds with a RWAR ≥ 40% was 47% and 44% for the DCS and 4LB systems, respectively. Pain between dressing changes was reported in 27% and 40% and the incidence of adverse events was 17% and 25% in the DCS versus 4LB group. The DCSwas considered to be significantly easier to apply than the 4LB (p=0.038).
Conclusion: The Dual Compression System system has similar efficacy than the 4LB system in the management of VLUs. The ease of application of the DCS combined with good local tolerance will help promote patient concordance and aid clinicians when treating VLU
Trademarked Items (if applicable): *UrgoK2
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