Observational study of venous leg ulcer treated with a native collagen-alginate dressing and the impact on wound-related quality of life.

Abstract

Background: Venous leg ulcers (VLUs) are associated with various physical and social adverse effects for patients but also contribute to a significant socioeconomic burden.

Purpose: To examine the clinical performance and safety of a collagen-alginate dressing in combination with standard wound care in non-healing VLUs.

Methods: In an observational, explorative, single-center study, VLUs of 60 patients were covered with a collagen-alginate dressing. Wounds were assessed during 5 visits over a 4-week period. At the final visit, health care professionals gave an overall assessment of the dressing. Outcome parameters were wound area reduction, wound pain, wound-related quality of life (QoL), and incidence of adverse events.

Results: The mean wound area decreased (17.8 ± 11.2 cm² versus 11.4 ± 9.0 cm²; P < .0001), and 4 patients achieved complete closure. Wound pain decreased after 2 weeks, and intake of analgesics reduced. Patients' wound-related QoL improved and a correlation between the well-being sub-score and wound area reduction was found. All health care professionals rated the collagen-alginate dressing as 'very good' or 'good.'

Conclusion: The collagen-alginate dressing is safe and effective in promoting healing and addressing the pain of VLUs. It also improves patients' QoL, possibly by reducing wound area, pain, and exudate.