Status:
WITHDRAWN
Study Evaluating AWBAT-D Versus the Standard of Care of Split-thickness Skin Graft Donor Sites
Lead Sponsor:
Georgetown University
Conditions:
Healing of Donor Site
Pain Level
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Use of AWBAT-D on split thickness skin graft sites will reduce healing time and pain level.
Detailed Description
The study is designed as a randomized-controlled trial to examine split thickness skin graft donor wound site healing using AWBAT-D compared to current standard of care: Tegaderm. This will involve ra...
Eligibility Criteria
Inclusion
- Subject is 18 years of age or older
- Subjects requiring a split-thickness skin graft with a wound size between 5 and 50cm2 and a depth between 12-18um.
- Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.
Exclusion
- Subjects \< 18 years of age
- Subjects with an allergy to porcine products.
- Subjects undergoing STSG with a wound size less than 5 cm2 or greater than 50cm2.
- Subjects undergoing STSG with a wound depth of less than 12um or greater than 18um.
- Subjects undergoing repeat skin graft harvesting at the same donor site.
- Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
- Subjects participating in any other trials involving the split-thickness skin graft donor site.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01252836
Start Date
September 1 2010
End Date
April 1 2015
Last Update
December 15 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Georgetown University Hospital Center for Wound Healing
Washington D.C., District of Columbia, United States, 20007