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

Arteriocyte Medical Systems

Status and phase

Unknown

Phase 1

Conditions

Acute Deep Partial Thickness Thermal Burns

Treatments

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

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT02169362

ART 13-005

IDE 15921 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 86 years old

Volunteers

No 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