Using Autologous Platelet Rich Plasma (PRP) Gel to Treat Deep 2nd and 3rd Degree Burns
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.
Other: Placebo Saline Gel and Usual and Customary Standard of Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Use of Autologous Platelet Rich Plasma (PRP) Gel as an Adjunct to the Treatment of Deep 2nd and 3rd Degree Burns|
- Demonstrate the safety of application of autologous platelet rich plasma (PRP) gel following excision of an acute deep 2nd and 3rd degree burn. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]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
- Assessment of a composite of wound healing measurements [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
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 two consecutive study visits two weeks apart)
- 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 TcPO2 using physiological markers.
- Assessment of wound flora, dermal collagen and elastin content, and epithelialization using tissue markers.
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Autologous Platelet Rich Plasma (PRP)
Magellan Autologous Platelet Separator
Autologous Platelet Rich Plasma Prepared Using the Magellan System
Other Name: Autologous Platelet Rich Plasma
|Placebo Comparator: Saline Gel, Standard of Care||Other: Placebo Saline Gel and Usual and Customary Standard of Care|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843686
|Contact: Ann Charestfirstname.lastname@example.org|
|Contact: Diane Orinoemail@example.com|
|United States, California|
|University of California, Davis, Division of Burn Surgery||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Katrina Falwell, RN BSN 916-453-2134 firstname.lastname@example.org|
|Contact: Lynda E Painting, BS, CCRP, CCRC 916-453-5085 LPainting@Shrinenet.org|
|Principal Investigator: Tina Palmieri, MD|
|United States, Utah|
|University of Utah Hospital||Recruiting|
|Salt Lake City, Utah, United States, 84132|
|Contact: Yan Zhai 801-587-7249 Yan.Zhai@hsc.utah.edu|
|Contact: Iris Faraklas, BSN 801-585-2489 email@example.com|
|Principal Investigator: Amit N Patel, M.D., M.S.|
|Sub-Investigator: Amalia Cochran, M.D., FACS|
|Principal Investigator:||Amit N Patel, M.D., M.S.||University of Utah Hospital|