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Applying Platelet Rich Plasma (PRP) Gel to Acute Deep Partial Thickness Thermal Injuries | Clinical Trials | Clareo Health

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

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

NCT02169362•Arteriocyte, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 86 years

Sex

ALL

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)
+4 more criteria

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
+17 more criteria

Locations (8)

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

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

Key Dates

Start Date

July 1, 2014

Primary Completion Date

January 1, 2018

Completion Date

May 1, 2018

Last Updated

April 13, 2017

Enrollment

ACTUAL participants

Conditions

Acute Deep Partial Thickness Thermal Burns

Interventions

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

DEVICE