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).