The study will examine the safety of using a concentration of proteins from a patient's own blood, referred to as platelet rich plasma or (PRP) and applying it to a second degree burn wound.
The objective of this trial is to demonstrate the safety of applying autologous PRP gel (Magellan® Bio-Bandage™) to acute deep partial thickness thermal burns in the first days after burn injury. The Magellan® Bio-Bandage™ Burn Wound Care Kit is intended for the preparation and application of an autologous biological covering to deep partial thickness burn wounds to delay or minimize skin grafting requirements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Application of up to 18 mL of autologous PRP gel (Magellan® Bio-Bandage™) to the surface of an acute deep partial thickness burn wound no greater than 72 cm squared within 72 hours of the initial injury. Intervention is in addition to standard of care treatment. The PRP Bio-Bandage™ is prepared using the Magellan® System and is FDA cleared via BK030040 and BK040068.
Arizona Burn Center
Phoenix, Arizona, United States
University of California, Davis Medica Center
Sacramento, California, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
Safety as measured by Adverse Events
The primary objective of this trial is to demonstrate the safety of applying autologous PRP gel to acute deep partial thickness thermal burns in the first days after burn injury. The primary endpoint of this study will be safety. Incidence of Adverse Events and/or Serious Adverse Events will be documented, along with time to wound closure.
Time frame: Days 1 -365
Delay or minimization of skin grafting requirements following burn injury
This outcome will be evaluated by time to graft (days), need for graft (yes or no), and incidence of graft occurrence ( percentage of subjects in control group versus treatment group requiring a skin graft).
Time frame: Change will be assessed up to 35 Days
Improved wound healing trajectory as compared to standard of care
Wound healing will be assessed by calculating wound size measurements and percentage of change over time utilizing digital photography and planimetry software.
Time frame: Change will be assessed up to 365 Days
Increased rate of wound closure as compared to standard of care
The percentage of treated subjects versus standard of care only subjects with complete wound closure at 28 and 42 days post-burn injury. Wound closure will be defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive visits.
Time frame: Change will be assessed up to 365 Days
Reduced scarring, pain and pruritus
This outcome will compare treated subjects to standard of care only subjects by analyzing photo images and scar scale analysis (principal investigator and blinded rater assessments), and based on subject reported pain and pruritus.
Time frame: Change will be assessed up to 365 Days
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Tampa General Hospital/University of South Florida
Tampa, Florida, United States
University Medical Center Southern Nevada, Lions Regional Burn Center
Las Vegas, Nevada, United States
Jaycee Burn Center at University of North Carolina
Chapel Hill, North Carolina, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Firefighters' Regional Burn Center
Memphis, Tennessee, United States
Improved Skin-Healing Quality
Histological analysis of 2mm skin biopsies taken at Baseline (Day 1) and 90 days post-treatment will be analyzed and compared. Biopsies will be taken only from subject for whom a skin graft was not required, and from both treated subjects and standard of care only subjects.
Time frame: Change will be assessed up to 365 Days