Safety and Performance of Dressing Adhesive on Healthy Volunteers Clinical Trial
Official title:
A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing
AQUACEL® foam adhesive dressing is a sterile Hydrofiber® foam wound dressing consisting of a waterproof outer polyurethane film, and a multi-layered absorbent pad, having a silicone adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a non-woven wound contact layer of Hydrofiber® (NaCMC). This dressing product was launched in 2012. A new source of silicone adhesive is now under assessment for this product. This Healthy Volunteer Wear test will form part of the Design Validation for this change in supplier and is required to confirm that the new Silicone Adhesive trilaminate supplier can coat the silicone adhesive to provide comparable adhesive dressing performance in terms of wear time, ease of use and with a similar safety profile in relation to the skin.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)