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.

Study Overview

• Status: Completed
• Conditions: Safety and Performance of Dressing Adhesive on Healthy Volunteers
• Intervention / Treatment: Device: AQUACEL® foam adhesive dressing

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Flintshire
    • Deeside, Flintshire, United Kingdom, CH5 2NU
      • Global Development Centre, Deeside Industrial Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All study participants: AQUACEL® foam adhesive dressings; Original adhesive + test adhesive	Device: AQUACEL® foam adhesive dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; Conformability1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor; Dressing Integrity1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor; Ease of Application1 = 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 removal1 = 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Principal Investigator: Gwen Lawrence, RGN, Wirral University Teaching Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: May 10, 2013
• First Submitted That Met QC Criteria: July 9, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: May 16, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Performance and safety of the AQUACEL® foam adhesive dressing
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: CW-0209-13-U368