(CR-033) A Prospective, Multi-Center Clinical Study to Assess the Performance and Safety of a Novel Silicone-Based Foam Dressing to Treat Venous Leg Ulcers

Philip Davies, BSc – Senior Medical Affairs Manage, Medical and Professional Affairs, Wound Care, Molnlycke Health Care

Introduction: Venous leg ulcers (VLU) are often highly exudative and dressings with various absorptive capacities are available to address this clinical challenge. However, little attention is given to the ability of dressings to work against gravity while handling large exudate amounts in VLU. We tested the performance of a new, innovative, silicone-based, non-bordered foam dressing* in treatment of exudative VLU. Here, we report preliminary results on performance and safety.

Methods: We enrolled adults with moderate to severely exudative VLU into a six-weeks, prospective, multi-center, non-comparative investigation.  The overall objective was to follow the progress of exuding chronic wounds for up to six weeks or until healing, while using the new product* as the primary absorbent dressing. Wound progress was assessed based on an objective measurement of wound area and a subjective evaluation of the wound’s condition at each scheduled visit by comparing the wound status to that observed at the previous visit.  Secondary outcome measures included: wound condition (viable/non-viable tissue), exudate (amount/consistency), dressing change-related pain, and patient quality of life. An interim analysis of the data relating to enrolled patients with VLUs was undertaken

Results: The data available for analysis included 21 subjects. At 65.7% of the follow-up visits, wound progress was judged to have improved compared to the previous visit (27.4% not changed, 7% deteriorated).  Overall, the wound-related secondary endpoint measurements were in alignment with the reported primary outcome.  At 86% of the follow-up visits, the overall use of the dressing was rated as ‘good’ or ‘very good’ by the investigators.  None of the reported

Discussion:

The findings of the interim analysis indicate that, in terms of performance and safety, the new dressing* is suitable for the management of exuding VLUs.  The analysis of the full data set will help to determine the suitability of the new dressing for use on other chronic wound types.