Efficacy, safety and acceptability of a new two-layer bandage system for venous leg ulcers.

OBJECTIVE: To evaluate the efficacy, tolerability and acceptability of a new two-bandage compression system in the local management of venous or mixed aetiology ulcers predominantly of venous origin. 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 ulcer surface area at inclusion was 7 +/- 6 cm2. The mean surface reduction after six weeks was 58.5%, with 24% of the treated wounds healing in a mean time of 25.9 +/- 9.46 days. The patients considered that the new compression system had a better effect on quality of life, evaluated by parameters such as pain, heat, itching and general comfort, than the system worn before entry into the study. Patient concordance with the new system was excellent and 86% of leg ulcers improved or healed after six weeks. Local tolerance was considered very good. CONCLUSION: This new two-bandage compression system is effective and well accepted by patients.