Applying Platelet Rich Plasma (PRP) Gel to Acute Deep Partial Thickness Thermal Injuries

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Phase I, Double-Blind, Randomized, Controlled Study to Demonstrate the Safety of Applying Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) to Acute Deep Partial Thickness Thermal Injuries

Conditions
-----------------
Acute Deep Partial Thickness Thermal Burns

Intervention / Treatment
-----------------
* Device: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent will be obtained prior to study participation Male or female age ≥ 18 years of age or ≤ 86 years of age Total burn wound measuring ≤ 25% TBSA Burn wound area to be treated must be a deep partial thickness wound Burn wound area to be treated must be ≤72 cm2 and surrounded by a perimeter of healthy skin Able and willing to comply with the procedures required by the protocol. Subjects may be managed as either inpatient or outpatient. If a female of childbearing potential, the subject must have a negative serum pregnancy test at screening All subjects, male and female, must use acceptable method(s) of birth control for the duration of the study Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control): Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry) A partner who is physically unable to impregnate the subject (e.g., vasectomized) Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to subject's cell concentrate administration Intrauterine device (IUD), or Double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream) Exclusion Criteria: Conductive electrical, friction or chemical burns Burns to the digits, head, genitalia, palms of hands, soles of feet, and face that are the only possible sites for treatment (subjects with burns elsewhere in addition to these sites may be enrolled in the study) Burns that pose a risk to digits or limbs Subjects who have gone into hemorrhagic shock following burn injury Subject was medically treated for insulin-dependent or non-insulin-dependent diabetes mellitus prior to burn injury per subject medical history Venous or arterial vascular disorder directly affecting a designated test area Known immune deficiency disorder, either congenital or acquired Chronically malnourished as determined clinically by the investigator. (Investigators are responsible for determining if subjects are chronically malnourished during the screening process. Investigators should take into consideration the following parameters: medical history and physical appearance, the subject's body mass index, and any significant laboratory findings) Severe respiratory problems or concurrent head trauma at hospital admission, including inhalation injury requiring ventilator support Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study Use of COX-1 and/or COX-2 inhibitors within 48 hours prior to treatment. Subjects must refrain from use of NSAIDs for five days after Visit 2. Any other acute or chronic concurrent medical condition(s) that, in the investigator's opinion, are a contraindication to study participation or limit the subject's life expectancy to < 6 months Known or suspected hypersensitivity to Recothrom® Concurrent participation in another clinical trial in which an investigational agent is used. (Subjects must not have been enrolled in another clinical trial within 30 days of enrolling in this trial) Females who are pregnant or nursing or intend to become pregnant during the duration of the study Burn wounds that occur over joints Known allergies to silver, adhesive products or silicone. Subjects with the following abnormal laboratory test levels: Stage 4 or greater chronic kidney disease (eGFR < 30 mL/min Hemoglobin < 10 g/dl Thrombocytopenia < 100,000 platelets/µl. Serum albumin level < 2.5 g/dl or > 30 g/dl at time of screening Liver function*: AST- Males and Females, >2.5 ULN ALT- Males and Females, >2.5 ULN Alkaline Phosphatase- Males and Females: >2.0 ULN Total bilirubin- Males and Females >2.0 ULN

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 86 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma - Bio-Bandage™<br>Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) | Device: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)<br>* 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.<br>* Other names: The Magellan® System;|
| Sham Comparator: Saline Spray, Standard of Care<br> | Device: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)<br>* 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.<br>* Other names: The Magellan® System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Days 1 -365 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | Change will be assessed up to 365 Days | 
| 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. | Change will be assessed up to 365 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute burns, Burn wounds, Burns, Thermal burns, Second degree burns, Partial thickness burns, Deep partial thickness burns