MedTrace Logo

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

NCT01897285 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-06-17

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Safety and Performance of Dressing Adhesive on Healthy Volunteers

Interventions

DEVICE

AQUACEL® foam adhesive dressing

Sponsors & Collaborators

  • ConvaTec Inc.

    lead INDUSTRY

Principal Investigators

  • Gwen Lawrence, RGN · Wirral University Teaching Hospital NHS Trust

Study Design

Allocation
NA
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01897285 on ClinicalTrials.gov