Completed

NCT Number: NCT01897285

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.

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Key information

Conditions

Safety and Performance of Dressing Adhesive on Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Global Development Centre, Deeside Industrial Park

Deeside, Flintshire, CH5 2NU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AQUACEL® foam adhesive dressing

Device

Primary outcomes

Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)

Time frame: 7 days
- 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)

Secondary outcomes

Safety - the Nature and Frequency of Adverse Events

Time frame: 7 days

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.

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jul 11, 2013
Registry last updated: Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.