Status:
COMPLETED
Comparative Evaluation of Two AQUACEL Ag Protocols of Care for the Management of Donor Sites
Lead Sponsor:
ConvaTec Inc.
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Split-Thickness Donor Sites.
Eligibility:
All Genders
Phase:
PHASE3
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 uti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00731367
Start Date
October 1 2005
End Date
August 1 2006
Last Update
February 3 2009
Active Locations (1)
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1
Maricopa Medical Center
Phoenix, Arizona, United States, 85008