Randomized controlled trial and cost-effectiveness analysis of silver-donating antimicrobial dressings for venous leg ulcers (VULCAN trial).

BACKGROUND Antimicrobial silver dressings are used beneath graduated compression in the treatment of venous ulceration. There is little information on whether their use is effective. This was a prospective randomized trial and cost-effectiveness analysis of silver-donating versus non-silver low-adherence dressings in the treatment of venous leg ulcers. METHODS Patients were randomized between the two types of dressing. The primary outcome measure was complete ulcer healing at 12 weeks. Secondary outcomes included time to healing, quality of life and cost-effectiveness. RESULTS A total of 213 patients were recruited. There was no difference between the dressings in the proportion of ulcers healed at 12 weeks (59.6 per cent for silver and 56.7 per cent for control dressings). Mean utility scores for the EuroQol 5D and Short Form 6D were similar in both groups at 1, 3, 6 and 12 months. Compared with the control group the antimicrobial group had an incremental cost of pounds sterling 97.85 and an incremental quality-adjusted life year gain of 0.0002, giving an incremental cost-effectiveness ratio of pounds sterling 489 250 for the antimicrobial dressings. CONCLUSION No significant differences were found in either primary or secondary endpoints. There was no evidence to support the routine use of silver-donating dressings beneath compression for venous ulceration. REGISTRATION NUMBER ISRCTN 72485131 (http://www.controlled-trials.com).