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



Status:Recruiting
Conditions:Other Indications, Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:October 1999

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OBJECTIVES:

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


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.

- Thermal burns that require skin grafts 3 or more weeks after admission to the
hospital

- Not pregnant
We found this trial at
2
sites
Cincinnati, Ohio 45229
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Cincinnati, OH
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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Cincinnati, OH
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