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

Sponsor

Arteriocyte, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02169362

Collaborator

Department of Health and Human Services (U.S. Fed)

Enrollment

Locations

Arms

Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Deep Partial Thickness Thermal Burns	Device: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Platelet Rich Plasma - Bio-Bandage™ Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)	Device: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) 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. Other Names: The Magellan® System
Sham Comparator: Saline Spray, Standard of Care	Device: Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) 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. Other Names: The Magellan® System

Arm

Intervention/Treatment

Experimental: Platelet Rich Plasma - Bio-Bandage™

Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)

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

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.

Other Names:

The Magellan® System

Sham Comparator: Saline Spray, Standard of Care

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

Other Names:

The Magellan® System

Outcome Measures

Primary Outcome Measures

Safety as measured by Adverse Events [Days 1 -365]
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.

Secondary Outcome Measures

Delay or minimization of skin grafting requirements following burn injury [Change will be assessed up to 35 Days]
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).
Improved wound healing trajectory as compared to standard of care [Change will be assessed up to 365 Days]
Wound healing will be assessed by calculating wound size measurements and percentage of change over time utilizing digital photography and planimetry software.
Increased rate of wound closure as compared to standard of care [Change will be assessed up to 365 Days]
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.
Reduced scarring, pain and pruritus [Change will be assessed up to 365 Days]
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.
Improved Skin-Healing Quality [Change will be assessed up to 365 Days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 86 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Burn Center	Phoenix	Arizona	United States	85008
2	University of California, Davis Medica Center	Sacramento	California	United States	95817
3	MedStar Health Research Institute	Washington	District of Columbia	United States	20010
4	Tampa General Hospital/University of South Florida	Tampa	Florida	United States	33606
5	University Medical Center Southern Nevada, Lions Regional Burn Center	Las Vegas	Nevada	United States	89102
6	Jaycee Burn Center at University of North Carolina	Chapel Hill	North Carolina	United States	27599
7	Lehigh Valley Health Network	Allentown	Pennsylvania	United States	18103
8	Firefighters' Regional Burn Center	Memphis	Tennessee	United States	38104