Thermal Injury Clinical Trial
Official title:
Evaluation of Autologous Engineered Skin Substitute (ESS-W) Compared to Meshed, Split-Thickness Autograft (AG) for Treatment of Deep Partial- and Full-Thickness Thermal Burn Wounds in Adult Patients
The purpose of this research study is to test how well the investigational treatment,
Engineered Skin Substitutes (ESS-W), works for covering and treating burn wounds.
The areas of the body that are treated with ESS-W will be compared to similar areas treated
with the patient's own skin (split-thickness skin autograft (AG)). A skin autograft (AG)
will be performed by taking healthy skin from one area of the body and placing it on the
burned area.
This study is designed to evaluate the safety and efficacy of autologous engineered skin
substitute (ESS-W) compared to conventional split-thickness AG for the treatment of
extensive, deep partial- and full-thickness thermal burns. A matched and randomized burn
site format will be used to evaluate the successful graft take on excised deep partial- and
full-thickness burns when grafted with either 1) unmeshed ESS-W or 2) meshed AG (the current
standard treatment of split thickness AG).
This research study is divided into five study periods: (1) Screening Period of up to one
week and (2) Pre-Grafting Period, which will last approximately 35-45 days, (3) Grafting
Day(s), which are the day(s) on which grafts are applied (i.e., First Graft: Day 0 and the
optional subsequent Grafting Day i.e., Second Graft: Day 0), (4) Post Grafting Observation
Period, which begins with 28 days follow-up after each Grafting Day(s), and continues till
Post-Operative Month (POM) 6 from the last Grafting Day, and (5) Anecdotal Observation
Period
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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