Status:
COMPLETED
Evaluation of Dermafill Dressing for Donor Sites
Lead Sponsor:
United States Army Institute of Surgical Research
Conditions:
Burns
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to compare one type of dressing against the current standard dressing that is used to cover the unburned area of the skin where a piece of skin is removed to cover another ...
Detailed Description
At the time of the procedure, donor sites that are symmetrical in size and shape will be selected. The donor sites will be harvested. Once the grafts have been harvested, the wounds will be randomized...
Eligibility Criteria
Inclusion
- 18 years or older; male or female.
- Burn wounds less than 30% of total body surface area (TBSA) with no systemic abnormalities
- Burns do not involve the harvesting area
- Burn wounds require excision and grafting of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas
- Scheduled excision and grafting procedure is the first such operation for subject during this hospitalization
- Subject agrees to participate in follow-up evaluations
Exclusion
- Critical illnesses requiring ventilator support, systemic infection or hemodynamic instability
- Major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder)
- Subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). The use of anticoagulants does not include deep venous thrombosis (DVT) prophylaxis.
- Cellulitis or other infection of potential donor site
- Previously harvested donor site
- Subjects with greater than 30% TBSA burns
- Pregnancy
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00137163
Start Date
March 1 2005
End Date
March 1 2007
Last Update
July 28 2008
Active Locations (1)
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1
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234-6315