(CR-020) Enhanced silver dressing versus dialkylcarbamoyl chloride-coated dressing in venous leg ulcers: a blinded re-assessment of randomized controlled trial findings

Constanza Cabrera, MD – Convacare Clinics, Bogotá, Colombia; Jan Ljungqvist, BSc – Convatec Technology Centre, Deeside, United Kingdom; Rebecca Rodger, BSc – Convatec Technology Centre, Deeside, United Kingdom; Beate Paintner-Hanson, MD – Convatec Technology Centre, Deeside, United Kingdom

Introduction: Venous leg ulcers (VLUs) are hard-to-heal wounds that pose a significant burden to patients and healthcare systems worldwide. A carboxymethylcellulose fibre dressing containing ionic silver, ethylenediaminetetraacetic acid, and benzethonium chloride (CISEB*) was designed to address the challenges of patients with hard-to-heal wounds. A previous randomized controlled trial (RCT) demonstrated a significantly higher rate of complete wound closure at 12 weeks with CISEB compared to a dialkylcarbamoyl chloride-coated dressing (DACC^†; 74.8% vs. 55.6%, p< 0.0031).¹ The current study aimed to validate these findings through an independent, blinded re-assessment of wound closure status.

Methods: Patients with hard-to-heal VLUs were randomized 1:1 to receive either CISEB or DACC for ≤4 weeks. Wounds not healed by week 4 were subsequently managed with standard of care for ≤12 weeks or until healed. The complete study design has been previously described.¹ The primary endpoint was incidence of complete wound closure at week 12, assessed by an independent, blinded reviewer using photographs. Inter-rater reliability was an exploratory endpoint. A post hoc tipping analysis modeled the probability of outcome reclassification based on disagreement rates.

Results: A total of 113 VLUs from 105 patients were included (CISEB: n=49; DACC: n=56). Agreement between the independent reviewer and the original RCT assessment was 94.7%, with a Cohen’s Kappa of 0.89, indicating ‘near-perfect’ agreement. Using the disagreement rate (5.3%) to enumerate all plausible reclassification scenarios, the tipping point analysis confirmed a 98% probability CISEB would retain its superiority if outcomes were reclassified based on the blinded assessment. When modelling a more conservative reclassification scenario using the upper bound of the 95% CI for the disagreement rate (11.1%), the probability of superiority remained high at 92.4%. High inter-rater agreement was generally observed across countries and study sites. By week 12, CISEB was associated with a higher rate of complete wound closure compared to DACC (63.5% vs. 59.0%).

Discussion: The strong inter-rater reliability supports the robustness of the results and reinforces the role of CISEB as a standard of care for managing hard-to-heal VLUs. Independent blinded assessment confirmed that CISEB improves wound closure rates in hard-to-heal VLUs compared to DACC, aligning with previous RCT findings.