An Open-label, Prospective, Comparative Human Participant Study to Evaluate the Clinically Acceptable Dressing Presence and Conformability Properties of Prototype Non-medicated Multilayer Foam Dressings Compared to Established Medical Devices

Detailed Summary

The purpose of this study is to evaluate two new prototype non-medicated multilayer foam dressings on healthy, intact skin. The study will find out how well two new prototype dressings stay in place as well as other dressing performance and safety factors when compared to corresponding, marketed dressings with a similar intended use profile and shape. The study will compare: 1. Prototype dressing (rectangle) vs Marketed dressing (rectangle) on the knee. 2. Prototype dressing (square) vs Marketed dressing (square) on the thigh. The main aim of the study is to show that the new prototype dressings are 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

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Interventions