Applying Platelet Rich Plasma (PRP) Gel to Acute Deep Partial Thickness Thermal Injuries
NCT ID: NCT02169362
Last Updated: 2017-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
36 participants
INTERVENTIONAL
2014-07-31
2018-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Platelet Rich Plasma - Bio-Bandage™
Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)
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.
Saline Spray, Standard of Care
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
86 Years
ALL
No
Sponsors
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Department of Health and Human Services
FED
Arteriocyte, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Barnes, PhD
Role: STUDY_DIRECTOR
Arteriocyte, Inc.
Locations
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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
Countries
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References
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Other Identifiers
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IDE 15921
Identifier Type: OTHER
Identifier Source: secondary_id
ART 13-005
Identifier Type: -
Identifier Source: org_study_id
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