Trial Information
Autologous Engineered Skin Substitutes for Closure of Burn Wounds
Inclusion Criteria:
- Burns greater than 50% of the total body surface area (TBSA), including 10% TBSA
full-thickness injury
- Subject is not septic
- Skin grafting expected after 3 weeks following the skin biopsy
- Informed Consent signed.
Exclusion Criteria:
- Subject is pregnant or lactating
- Subject is a prisoner
- Subject is mentally incompetent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The ratio of closed wound area to donor skin area for engineered skin substitutes compared to meshed, split-thickness skin autograft.
Outcome Time Frame:
Post-operative day 28+/-3
Safety Issue:
Yes
Principal Investigator
Richard Kagan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Faculty
Authority:
United States: Food and Drug Administration
Study ID:
FD-R-672
NCT ID:
NCT00591513
Start Date:
February 1998
Completion Date:
December 2013
Related Keywords:
- Burns
- Burn Scars
- Congenital Giant Nevi
- burns
- burn scars
- congenital giant nevi
- Burns
- Nevus
- Cicatrix