A Randomized Trial of Biofilm Dressing for Venous Leg Ulcers

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 significant...