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

Convatec

Status and phase

Completed

Phase 3

Conditions

Split-Thickness Donor Sites.

Treatments

Device: Aquacel Ag Gelled

Device: Aquacel Ag Adherent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00731367

CW-0412-05-A080

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

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.