Randomized Trial of an Occlusive Dressing in the Treatment of Chronic Non-Healing Leg Ulcers

Abstract

Objective: To determine whether an occlusive dressing improves healing in chronic resistant venous ulceration. Design: Prospective controlled randomized trial. Setting: Hospital outpatients and community ulcer Patients: Sixty patients with chronic non-healing venous ulceration. Patients had either been treated for 12 weeks and their ulcer had failed to reduce by 20% of their original size, or had failed to completely heal within 24 weeks of treatment with the four-layer bandage. Interventions: Patients continued treatment with the four-layer bandage, and randomized to receive either an occlusive dressing or a simple non-adherent (NA) dressing. Main outcome measure: Time to complete healing analysed by life tables up to 12 weeks from randomization. Results: At the end of the trial 43% of the patients randomized to an occlusive dressing and 23% to an NA dressing had completely healed. Life table analysis failed to show a significant difference (relative risk = 2.25; 95% confidence interval 0.88–5.75; p=0.077). Conclusions: Good response of patients to an occlusive dressing has indicated the need for a larger study. A trial of 180 patients could detect a significant difference if crude rates are maintained in a larger study (80% Power, 5% significance).