(CR-044) Leg ulcers treated with collagen alginate dressing lead to wound size reduction improving the quality of life of patients

Christina del Pin, M.D. – Attending Physician, Surgery, Northwell Health; Amit Rao, M.D. – Project Manager, Surgery, Northwell Health; Sally Kaplan, R.N. – Research Nurse, Surgery, Northwell Health; Farisha Baksh, B.S. – Research Coordinator, Surgery, Northwell Health

Introduction: Hard-to-heal chronic wounds, such as leg ulcers are a serious burden for healthcare systems worldwide and improvement of their healing outcomes are of high interest. An observational study was performed to examine the clinical performance and safety of a collagen alginate dressing in a routine clinical setting. Here we evaluate the impact of a collagen alginate dressing* on wound size reduction and wound-related quality of life and the impact on pain.

Methods: The study was performed between June 2021 and June 2022. A total of 60 patients with a venous leg ulcer were enrolled and 50 were observed for 28±3 days. Main outcomes included wound healing rate, the assessment of wound healing progression measured with wound assessment software, and changes in QoL of the patients, assessed with the validated wound-QoL questionnaire ⁽¹⁾. Pain was determined with a pain visual analog scale (VAS).

Results: 29 (58.0%) male and 21 (42.0%) female subjects were included in the analysis. The mean age was 68.7±14.6 years. All subjects participated in visits 1 to 3. Wound healing was observed in 3 patients at visit 3, and 47 completed the study with one reported wound healing at visit 5. Improvements from baseline to visit 5 were observed for the mean wound size reduction (5.1±7.8;, pain (2.3;) and wound-QoL global score (0.70;). The assessment of QoL could be attributed to three subscales on everyday life score (0.6;, body score (0.80; and psych, wellbeing of living with a wound, score (0.80; < 0.0001). A statistically significant correlation (t-test p-value: 0.0002) was identified for comparison of the relative and psychological wellbeing score reduction with the relative wound area reduction. Overall assessment by the HCPs was rated “very good” for 98% treatments.

Discussion: Chronic wounds often result in a prolonged and painful healing process that affects different dimensions of patients' QoL. Treatment with collagen alginate dressing lead to an improvement in wound healing, pain and wound-QoL global score. The data show a positive impact on patient suffering from VLU. Further studies involving RCT or multi-institutional trials may demonstrate further efficacy of the product.