An Open-label, Prospective, Comparative Human Participant Study to Evaluate the Clinically Acceptable Dressing Presence and Conformability Properties of a Prototype Multilayer Foam Dressing in Comparison to ALLEVYN◊ LIFE and Another Established Medical Device.

Signals

Detailed Summary

The purpose of this study is to evaluate a new prototype multilayer foam dressing on healthy, intact skin. The study will find out how well the new prototype dressing stays in place as well as other dressing performance and safety factors when compared to two corresponding, marketed dressings with a similar intended use profile and shape. The study will compare: 1. Prototype dressing vs Marketed dressing 1 on thighs and shins. 2. Prototype dressing vs Marketed dressing 2 on thighs and shins. The main aim of the study is to show that the new prototype dressing is not worse than the established marketed comparison dressings in terms of staying in place on human participants at 7 days. Dressings will have successfully stayed in place if the dressing edges have not lifted to reach the pad, and the pad is not exposed in any way. Additional data will be collected to further support product performance up to 7 days, including safety information and potential device issues.

Study Details

Timeline

Arms & Interventions

Interventions