A Randomized Trial of Biofilm Dressing for Venous Leg Ulcers

Abstract

Objective: Comparison of Biofilm dressing with Jelonet and Betadine in the treatment of venous leg ulcers. Design: Randomized parallel-group controlled trial, stratified by initial maximum ulcer diameter of 2–4 cm or >4 cm. Setting: Community. Patients: Five hundred and twenty-nine patients were assessed and 200 patients with clinical evidence of venous leg ulceration and initial ulcer diameter >2 cm were recruited to the trial. Patients with appreciable arterial disease (ratio of ankle to brachial systolic pressure <0.75) were excluded. Interventions: Ulcers were treated with either Biofilm (a hydrocolloid dressing) or Betadine and Jelonet in the community for 4 months or until the ulcer healed, if sooner. All patients wore standardized graduated compression. Main outcome measures: Time to complete healing of the ulcer, subjective assessment of pain and total cost of treatment. Results: Healing was more rapid in patients using Biofilm dressing (relative risk 1.16, 95% confidence interval 0.8–1.8), but not significantly so p = 0.48. Patients' subjective pain scores after 1 month of treatment indicated there was significantly less pain experienced by patients treated with Biofilm ( p = 0.02). The total cost of treatment (including dressings and nursing time) was similar for Biofilm and Betadine for small ulcers (<6 cm) but Biofilm cost three times as much for larger ulcers. Conclusion: Provided that standardized graduated compression was used, the primary dressing did not significantly affect the time to complete healing of the ulcer.