Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites

Phase 3

Completed

• Conditions: Split-Thickness Donor Sites.
• Interventions: Device: Aquacel Ag Gelled; Device: Aquacel Ag Adherent

• Registration Number: NCT00731367
• Lead Sponsor: ConvaTec Inc.

Brief Summary

This phase IIIb, randomized, comparative, multi-center study is designed to evaluate two AQUACEL Ag protocols of care for the management of split-thickness donor sites. Both protocols of care will utilize AQUACEL Ag as the primary dressing. As per the randomization assignment, one protocol of care will have the AQUACEL Ag initially covered with a gauze dressing to create an adherent state and in the other protocol of care the AQUACEL Ag will be covered with a transparent film to maintain a gelled state.

The primary objective of the study will be to quantify the proportion of subjects healed at 14 days. Secondary objectives will include: time to healing, degree of pain at dressing change and while wearing the dressing, simplicity of use, resources used in treatment and safety. Approximately 68 subjects will be enrolled from 10 centers from within the US and Canada.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2006-07
• Study Completion: 2006-08
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-11
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-02
• Last Update Posted: 2009-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Subject or legally authorized representative must provide written informed consent.
• Subject who is younger than legal consenting age must have a legally authorized representative who will provide written informed consent.
• The subject is scheduled to undergo a split-thickness skin graft (autograft)
• Harvesting of the donor site must be limited to the location and size of the anterior thigh
• The selected anterior thigh must be a first - time harvesting.

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Exclusion Criteria

• Subjects with known skin sensitivity to any of the dressing components.
• Subjects who require a full thickness graft.
• The subject with a poor prognosis, which would make it unlikely that he/she would survive the 21 day study period.
• Subjects who have been previously randomized into the study, or who are presently participating in another clinical trial.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gelled	Aquacel Ag Gelled	Aquacel Ag gelled.
Adherent	Aquacel Ag Adherent	Aquacel Ag adherent

Primary Outcome Measures

Name	Time	Method
To evaluate the proportion of subjects healed.	14 days

Secondary Outcome Measures

Name	Time	Method
Time to healing.	14 days
Degree of pain at dressing change.	14 days
Degree of pain/discomfort while wearing the dressing at rest and during mobility.	14 days
Investigator's rating of dressing performance (per subject and overall).	14 days
Resources utilization.	14 days
Readiness for re-harvesting.	day 14
Safety.	14 days +30

Trial Locations

Locations (1)

Maricopa Medical Center; 🇺🇸 Phoenix, Arizona, United States