(CR-050) Enhanced silver dressing improves slough and debridement in venous leg ulcers: post hoc analysis of a randomized controlled trial

Jan Ljungqvist, BSc – Convatec Technology Centre, Deeside, United Kingdom; Beate Paintner-Hanson, MD – Convatec Technology Centre, Deeside, United Kingdom; Janet Mackenzie, MD – Convatec Technology Centre, Lexington, MA, United States

Introduction: Venous leg ulcers (VLUs) are hard-to-heal wounds that impose a substantial burden on patients and healthcare systems worldwide. A carboxymethylcellulose fibre dressing containing ionic silver, ethylenediaminetetraacetic acid, and benzethonium chloride (CISEB*) has was developed to address the challenges associated with these wounds. In a previous randomized controlled trial (RCT), CISEB demonstrated a significantly higher rate of complete wound closure at 12 weeks compared with a dialkylcarbamoyl chloride-coated dressing (DACC^†; 74.8% vs. 55.6%, p< 0.0031).¹ This analysis evaluated slough and complete debridement outcomes from the RCT.

Methods: Patients with hard-to-heal VLUs were randomised 1:1 to receive CISEB or DACC for up to four weeks. VLUs not healed by week 4 were managed with standard of care for up to 12 weeks or until healed. The full study design has been previously described.¹ Slough tissue percentage and complete debridement status were assessed at baseline and Days 14, 28, 42, 56, 70, and 84. Outcomes included relative slough reduction, proportion of wounds fully debrided, and time to complete debridement.

Results: This post hoc analysis included 181 patients (CISEB: n=93; DACC: n=88). Baseline mean slough coverage was 37.6% for CISEB and 40.3% for DACC. At Day 14, the mean percentage slough reduction from baseline was 57.5% for CISEB vs 26.0% for DACC, representing a statistically significant difference (p=0.035). Slough improvement persisted to Day 84, with the mean percentage reduction reaching 88.1% (CISEB) vs 74.6% (DACC). Complete debridement was observed in 50.5% (CISEB) vs 40.9% (DACC) at baseline and 95.7% vs 84.1% at Day 84 (p=0.005). Median time to complete debridement was shorter for CISEB (14 days) compared to DACC (28 days).

Discussion:

CISEB demonstrated superior slough reduction and complete debridement compared with DACC. Faster debridement may help reduce infection risk and accelerate healing. These post hoc findings reinforce the RCT results and support the role of CISEB in managing hard-to-heal VLUs.