This study will demonstrate the safety of the application of autologous platelet rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree burns. The study will be a randomized, double-blinded controlled safety study. Investigators expect that the PRP will deliver improved hemostasis and growth factors at the wound site thus increasing the effectiveness of treatment at the wound site. This will lead to rapid production and delivery of an autologous therapy that should minimize additional morbidity to the patient.
The goal of this study is to demonstrate the safety of the application of autologous platelet rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree burns. This treatment is intended to stimulate rapid healing and improve the outcome of standard of care treatments for burns common to active duty military personnel, and more broadly for treatment of all acute burns. The care is specific to excision and split thickness skin grafting in the context of this burn study. The study will enroll 42 patients receiving surgical management of acute 2nd and 3rd degree burns requiring excision and skin grafting. The patient's total body surface area burn injury should not exceed 20%. The study will be conducted for 12 months. This study will provide further information for the development of enhanced treatment of wound-deployable cellular therapy for advanced trauma care of burned warriors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Autologous Platelet Rich Plasma Prepared Using the Magellan System
University of California, Davis, Division of Burn Surgery
Sacramento, California, United States
Medstar Health Research Institute
Washington D.C., District of Columbia, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Demonstrate the safety of application of autologous platelet rich plasma (PRP) gel following excision of an acute deep 2nd and 3rd degree burn.
Examine that there is no increase in adverse events above what is seen with excision and split thickness autografting of deep 2nd and 3rd degree burns
Time frame: 12 Months
Assessment of a composite of wound healing measurements
This treatment is intended to stimulate rapid healing and improve outcomes of standard of care burn treatments: * Time to 100% healing and time to complete wound closure (skin re-epithelialization without drainage or dressing requirements confirmed at study visits wound remained closed for at least 14 days) * Length of hospital stay * Time for return to full activity clinical wound measurement with respect to wound surface area and need for reoperation. * Monitoring improvement of scar appearance. * Assessment of wound flora, dermal collagen and elastin content, and epithelialization using tissue markers.
Time frame: 12 Months
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