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

NCT02169362 | Unknown Phase 1 DMC

• 2 other identifiers: ART 13-005IDE 15921
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Acute Deep Partial Thickness Thermal Burns

Keywords

Burns; Thermal burns; Second degree burns; Partial thickness burns; Deep partial thickness burns; Acute burns; Burn wounds

Outcome Measures

Primary Outcomes (1)

• Safety as measured by Adverse Events

  The primary objective of this trial is to demonstrate the safety of applying autologous PRP gel to acute deep partial thickness thermal burns in the first days after burn injury. The primary endpoint of this study will be safety. Incidence of Adverse Events and/or Serious Adverse Events will be documented, along with time to wound closure.

  Days 1 -365

Secondary Outcomes (5)

• Delay or minimization of skin grafting requirements following burn injury

  Change will be assessed up to 35 Days

• Improved wound healing trajectory as compared to standard of care

  Change will be assessed up to 365 Days

• Increased rate of wound closure as compared to standard of care

  Change will be assessed up to 365 Days

• Reduced scarring, pain and pruritus

  Change will be assessed up to 365 Days

• Improved Skin-Healing Quality

  Change will be assessed up to 365 Days

Study Arms (2)

Platelet Rich Plasma - Bio-Bandage™

EXPERIMENTAL

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

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

Saline Spray, Standard of Care

SHAM COMPARATOR

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

Interventions

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

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.

Also known as: The Magellan® System

Platelet Rich Plasma - Bio-Bandage™; Saline Spray, Standard of Care

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Arteriocyte, Inc.: lead
• Department of Health and Human Services: collaborator

Study Sites (8)

Arizona Burn Center

Phoenix, Arizona, 85008, United States

Location

University of California, Davis Medica Center

Sacramento, California, 95817, United States

Location

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

Tampa General Hospital/University of South Florida

Tampa, Florida, 33606, United States

Location

University Medical Center Southern Nevada, Lions Regional Burn Center

Las Vegas, Nevada, 89102, United States

Location

Jaycee Burn Center at University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Firefighters' Regional Burn Center

Memphis, Tennessee, 38104, United States

Location

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MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Brian Barnes, PhD

  Arteriocyte, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: June 23, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 13, 2017

Record last verified: 2017-01

Locations

US (8)