Status:
COMPLETED
A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing
Lead Sponsor:
ConvaTec Inc.
Conditions:
Safety and Performance of Dressing Adhesive on Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01897285
Start Date
May 1 2013
End Date
May 1 2013
Last Update
June 17 2016
Active Locations (1)
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1
Global Development Centre, Deeside Industrial Park
Deeside, Flintshire, United Kingdom, CH5 2NU