Study to Assess Wearing and Adhesive Properties of Three Silicone Self-adhesive Devices on Healthy Skin

What this Trial Is About

This research aims to evaluate the self-adhesive properties of three different investigational silicone devices designed as dressings. The study is conducted with healthy volunteers to compare two investigational devices against a reference device, focusing on their ability to stay adhered over time. The investigation is exploratory and single-center, involving non-sterile silicone self-adhesive devices. Participants will have 12 dressings applied to designated areas on their backs to test and compare the dressings staying power. The dressings will be worn for up to 14 days, and the study will assess the dressing and application regimen during this period. The investigation includes the application and monitoring of these devices on intact skin with minimal hairiness. During the study, volunteers will undergo multiple visits and assessments to monitor the dressings and application sites. Researchers will measure the primary outcome of how well the devices stay on from enrollment until 14 days later. Participants must follow specific instructions to avoid contact with water, detergents, and cosmetics on the application sites during the study. The total participation duration lasts approximately two weeks, and adherence to the protocol is closely observed.

An Investigation to Evaluate Wearing Properties of Three Different Investigational Devices