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Clinical Research

(CR-006) Key performance characteristics of a new 5-layer silicone foam dressing in a randomized, controlled, prospective, human volunteer trial

Friday, April 10, 2026
Michael Howarth, MSc; Adam Tompkin, BSC (Hons); Yueming Shi, Master of Applied Statistics
Introduction: Assessment of foam dressing clinical performance using standardized laboratory tests has limitations. Volunteer studies are a robust method to assess dressing presence during wear1,2. This large volunteer trial evaluated a new, 5-layer foam dressing against two marketed 5-layer foam dressings for non-inferiority using stringent assessment criteria.

Methods: A single-centre, open-label, prospective, randomized volunteer study evaluated three, 5-layer silicone foam dressings over 7 days. All dressings were applied to participants’ thighs and shins (2 of Dressing 1* [n=240]; 1 each of marketed Dressings 2† and 3‡ [n=120 each]). The primary endpoint was Acceptable Dressing Presence (ADP; definition: dressing presence with no border lift, pad exposure, or tears) at day 7. Secondary endpoints included dressing presence, and participant reported pain on dressing removal.  Newcombe’s score method (15% non-inferiority threshold) was utilized.

Results: For the Full Analysis Set (FAS; n=120), ADP (day 7) was 72.9%, 83.3% and 65.0%, and dressing presence (day 7) was 95.0%, 94.5% and 90.9%, for Dressings 1, 2 and 3, respectively. Post-hoc analysis (mixed logistic regression model) indicated that Dressing 1 had a significantly higher rate of ADP than Dressing 3 (p=0.03). At day 7, all participants reported either ‘None’ or ‘Mild’ pain upon dressing removal, for all dressings.

Discussion: This new 5-layer foam dressing performed well in key performance characteristics of dressing presence and low participant reported pain scores. Application of stringent clinical performance criteria can highlight differences versus conventional endpoints.