OBJECTIVES: I. Determine the safety and efficacy of biosynthetic skin substitute as a routine therapy for treatment of severe burn injuries.

Condition	Treatment or Intervention	Phase
Burns	Procedure: Skin graft	Phase II

PROTOCOL OUTLINE: This is a randomized study. Two wound sites of similar area and depth are selected on each patient to receive the study treatments. One site is randomized to receive cultured skin substitute (CSS) grafts and the other receives split-thickness skin grafts (STSG). Prior to randomization all wounds are treated according to prevailing standards of burn care. CSS and STSG are surgically applied approximately 21 to 28 days after a thin split thickness autograft is harvested to prepare CSS grafts. Each wound is excised and irrigated prior to the application of either CSS or STSG. Patients are followed for at least 1 year after treatment.

Ages Eligible for Study:  up to  75 Years,  Genders Eligible for Study:  Both

Criteria

• Thermal burns that require skin grafts 3 or more weeks after admission to the hospital
• Not pregnant

Ohio
      Shriners Burns Hospital, Cincinnati,  Ohio,  45229,  United States; Recruiting
      University of Cincinnati Medical Center, Cincinnati,  Ohio,  45267-0562,  United States; Recruiting

Study chairs or principal investigators

Steven T. Boyce,  Study Chair,  University of Cincinnati   

Study ID Numbers:  199/13305; UCMC-FDR000672; UCMC-IDE-G980023
Record last reviewed:  January 2000
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004413
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09