A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing

Convatec

Status: Completed

Conditions: Safety and Performance of Dressing Adhesive on Healthy Volunteers

Treatments: Device: AQUACEL® foam adhesive dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT01897285

CW-0209-13-U368

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provide written informed consent
• Be a healthy volunteer and be over 18 years of age
• Be willing to attend two scheduled visits for application and removal of the device and adverse event review
• Have healthy unbroken skin

Exclusion criteria

• Subjects with a history of sensitivity to any one of the components of the device being studied
• Female subjects who are currently pregnant or lactating
• Subjects who are not willing and able to attend the 'clinic' for the required assessments
• Subjects with excessive hair on their backs
• Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study

Trial design

20 participants in 1 patient group

All study participants: AQUACEL® foam adhesive dressings

Experimental group

Description:

Original adhesive + test adhesive

Treatment:

Device: AQUACEL® foam adhesive dressing