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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Global Development Centre, Deeside Industrial Park | Deeside | Flintshire |
| Lead Sponsor | Collaborator |
|---|---|
| ConvaTec Inc. |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) | Adhesion at 7 days measured by: 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor Conformability 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor Dressing Integrity 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor Ease of Application 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor Ease of Removal, 1 = Very easy 2 = Easy 3 = Difficult 4 = Very difficult Adhesive Residue 0 = None 1 = Minimal 2 = Moderate 3 = Considerable Comfort during removal 1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor Condition of the skin This will be evaluated by the Skin Irritation Scale (Doubtful reaction/weak positive reaction/ strong positive reaction/ extreme positive reaction/irritant reaction/ negative reaction) |
7 days | Yes |
| Secondary | Safety - the Nature and Frequency of Adverse Events | Safety will be determined by the nature and frequency of Adverse Events. Condition of the skin under and around the dressings along with the incidence of skin irritation will be assessed. The incidence and nature of all adverse events will be recorded. Condition of the skin was evaluated by the Skin Irritation Scale. The possible responses are doubtful reaction, weak positive reaction, strong positive reaction, extreme positive reaction, irritant reaction, and negative reaction. |
7 days | Yes |