Effectiveness of an enhanced silver-containing dressing in hard-to-heal venous leg ulcers: a randomised controlled trial.

Abstract

Objective: To assess the efficacy and safety of a carboxymethylcellulose dressing containing ionic silver, ethylenediaminetetraacetic acid and benzethonium chloride (CISEB) versus a dialkylcarbamoyl chloride-coated dressing (DACC) in hard-to-heal venous leg ulcers (VLUs).

Method: In a multinational, multicentre, randomised controlled trial, patients with hard-to-heal VLUs were randomised 1:1 to receive CISEB (n=100) or DACC (n=103) for up to four weeks. VLUs that were not healed by week 4 were managed with standard of care for up to 12 weeks or until healed (whichever was sooner). The primary endpoint was complete wound closure at week 12. Additional endpoints included time to complete wound closure and incidence of adverse events (AEs).

Results: The trial cohort included 203 patients. CISEB achieved a higher rate of complete wound closure by week 12 compared to DACC (74.8% versus 55.6%, respectively; p<0.0031), and was associated with a 35% increased likelihood of healing (risk ratio, 1.35; 95% confidence interval: 1.10-1.65). Median time to complete wound closure was shorter in the CISEB arm (56 days) compared to the DACC arm (70 days; p<0.0272). A smaller proportion of patients experienced an AE with CISEB compared to DACC (5.0% versus 17.6%, respectively).

Conclusion: Management of hard-to-heal VLUs with CISEB was associated with improved healing outcomes compared to DACC, without additional safety concerns. CISEB is a gelling fibre dressing with antimicrobial, metal-chelating and surfactant components that may promote an optimal healing environment to address the challenge of hard-to-heal wounds.