A Randomized Trial of Biofilm Dressing for Venous Leg Ulcers

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Abstract
Comparison of Biofilm dressing with Jelonet and Betadine in the treatment of venous leg ulcers. Randomized parallel-group controlled trial, stratified by initial maximum ulcer diameter of 2–4 cm or >4 cm. Community. 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 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. Provided that standardized graduated compression was used, the primary dressing did not significantly affect the time to complete healing of the ulcer.