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Phase II Randomized Study of Cultured Skin Substitutes versus Split Thickness Skin Grafts in Patients with Severe Burn Injuries



Phase II Randomized Study of Cultured Skin Substitutes versus Split Thickness Skin Grafts in Patients with Severe Burn Injuries

For Condition: Burns
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , University of Cincinnati
Synopsis: OBJECTIVES: I. Determine the safety and efficacy of biosynthetic skin substitute as a routine therapy for treatment of severe burn injuries.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Efficacy Study
Minimum Age/Maximum Age: /75 Years
Genders: Both
Protocol Entry Criteria: - Thermal burns that require skin grafts 3 or more weeks after admission to the hospital - Not pregnant
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
StevenBoyce,  Study Chair,  University of Cincinnati

Shriners Burns Hospital *Recruiting*
Cincinnati,  Ohio,  45229
United States
Recruiting Steven  Boyce 513-872-6080

University of Cincinnati Medical Center *Recruiting*
Cincinnati,  Ohio,  45267-0562
United States
Recruiting Steven  Boyce 513-872-6080


Additional Information:
Study ID Numbers:
  199/13305;  UCMC-FDR000672,UCMC-IDE-G980023
Study Start Date: October 1999
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004413

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