Efficacy, safety, and acceptability of a new two layer compression bandage system in the management of venous leg ulcers: Results of a French multicenter clinical trial.

Objective: To evaluate the efficacy, tolerability and acceptability of a new two-layer multi-component compression system, also called the Dual Compression System (DCS)* in the local management of venous or mixed aetiology ulcers predominantly of venous origin. This product is designed to provide therapeutic pressure under both ambulatory and non ambulatory conditions.

Method: This was a prospective non-comparative open label phase III clinical study. Forty-two patients were recruited from 12 centres. Inclusion criteria included ulcers with at least 50% granulation tissue, a surface area of 2-20 cm2, an ulcer duration of 1-24 months, an ankle circumference of less than 28 cm, and no history of deep vein thrombosis in the three months before enrolment. The primary endpoint was reduction in ulcer surface area, and secondary endpoints were the evolution of leg oedema and patient comfort. During the six-week follow-up, patients underwent weekly clinical assessments and their ulcer surface area was measured by planimetry and photography every alternate week.

 
Results: The mean baseline ulcer surface area was 7±6 cm². The mean surface reduction after six weeks was 58.5% and 24% of wounds healed in a mean time of 25.9 ± 9.46 days. No major safety issues were identified during the trial. The impact of the compression system on patient daily lifestyle evaluated by parameters such as pain, heat, itching and general comfort was considered better than or identical to the previous compression worn by the patient. The concordance level of patients to this system was excellent and 86% of leg ulcers improved or healed after six weeks.

Conclusions: The results of this trial show that this new DCS compression system is effective and very well accepted by the patients.

Trademarked Items (if applicable): *UrgoK2

References (if applicable): Hanna R, Bohbot S, Connolly N. A comparison of
interface pressures of three compression bandage
systems. Br J Nurs 2008; 17(20): 16-24.

Benigni JP, Lazareth I, Parpex P, et al. Efficacy, safety and
acceptability of a new two-layer bandage system for
venous leg ulcers. J Wound Care 2007; 16(9): 385-90.

Jünger M, Ladwig A, Bohbot S, Haase H. Comparison
of interface pressures of three compression bandaging
systems used on healthy volunteers. J Wound Care 2009;
18(11): 474-80.

Lazareth L, Moffatt C, Dissemond J, et al. Efficacy of two
compression systems in the management of VLUs: results
of a European RCT. J Wound Care 2012; 21(11): 553-65.