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

Status unconfirmed · Phase 1

Conditions studied: Acute Deep Partial Thickness Thermal Burns

In brief

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.

Key facts

Study ID

NCT02169362

Run by

Arteriocyte, Inc.

People needed

36

Starts

2014-07-01

Expected to finish

2018-05-01

Last updated by the study team

2017-04-13

Who can join

Age: 18 and older, up to 86. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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