Applying Platelet Rich Plasma (PRP) Gel to Acute Deep Partial Thickness Thermal Injuries (NCT02169362) | Clinical Trial Compass
UnknownPhase 1
Applying Platelet Rich Plasma (PRP) Gel to Acute Deep Partial Thickness Thermal Injuries
United States36 participantsStarted 2014-07
Plain-language 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.
Who can participate
Age range18 Years – 86 Years
SexALL
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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, fri…