N/A N=20 Single-blind

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

Safety and Performance of Dressing Adhesive on Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT01897285 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin) — 6; 5; 1; 0 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AQUACEL® foam adhesive dressing (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: ConvaTec Inc.
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)	6; 5; 1; 0; 1; 1	—
SECONDARY Safety - the Nature and Frequency of Adverse Events	8; 5	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01897285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.