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