Using Autologous Platelet Rich Plasma (PRP) Gel to Treat Deep 2nd and 3rd Degree Burns

January 8, 2018 updated by: Arteriocyte, Inc.

Use of Autologous Platelet Rich Plasma (PRP) Gel as an Adjunct to the Treatment of Deep 2nd and 3rd Degree Burns

This study will demonstrate the safety of the application of autologous platelet rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree burns. The study will be a randomized, double-blinded controlled safety study. Investigators expect that the PRP will deliver improved hemostasis and growth factors at the wound site thus increasing the effectiveness of treatment at the wound site. This will lead to rapid production and delivery of an autologous therapy that should minimize additional morbidity to the patient.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to demonstrate the safety of the application of autologous platelet rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree burns. This treatment is intended to stimulate rapid healing and improve the outcome of standard of care treatments for burns common to active duty military personnel, and more broadly for treatment of all acute burns. The care is specific to excision and split thickness skin grafting in the context of this burn study. The study will enroll 42 patients receiving surgical management of acute 2nd and 3rd degree burns requiring excision and skin grafting. The patient's total body surface area burn injury should not exceed 20%. The study will be conducted for 12 months. This study will provide further information for the development of enhanced treatment of wound-deployable cellular therapy for advanced trauma care of burned warriors.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis, Division of Burn Surgery
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Medstar Health Research Institute
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent obtained either the subject or the subject's legally acceptable representative prior to screening activities
  • Male or female age ≥ 18 and ≤ 86 years of age
  • Total burn wound measuring ≤ 20% TBSA to include a deep partial thickness/full thickness area requiring surgical excision and autologous split thickness skin grafts
  • Hemoglobin HbA1c ≤7.5% (for patients with pre-existing diabetes mellitus)
  • Able and willing to comply with the procedures required by the protocol. Patients 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 participants, 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 the patient'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 burns and chemical burns
  • Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites
  • Burns that pose a risk to digits or limbs
  • Test area with infection as determined clinically by the investigator prior to surgery
  • 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 prior to surgery (Investigators are responsible for determining 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 ventilatory support
  • Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
  • Any other acute or chronic concurrent medical condition(s) that in the investigator's opinion are a contraindication to skin grafting and study participation or limit the participant's life expectancy to < 6 months
  • Known or suspected hypersensitivity to bovine protein
  • 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
  • Patients 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Platelet Rich Plasma (PRP)
Magellan Autologous Platelet Separator used to extract Platelet Rich Plasma from autologous whole blood. PRP is mixed with calcified thrombin to create a gel, which is place on the excised wound bed prior to application of split thickness autograft.
Device: Magellan®
Autologous Platelet Rich Plasma Prepared Using the Magellan System
Other Names:
  • Autologous Platelet Rich Plasma
Placebo Comparator: Saline Gel, Standard of Care
Normlgel Saline is placed on the excised wound bed prior to application of split thickness autograft.
Other: Placebo Saline Gel and Usual and Customary Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate the safety of application of autologous platelet rich plasma (PRP) gel following excision of an acute deep 2nd and 3rd degree burn.
Time Frame: 12 Months
Examine that there is no increase in adverse events above what is seen with excision and split thickness autografting of deep 2nd and 3rd degree burns
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of a composite of wound healing measurements
Time Frame: 12 Months

This treatment is intended to stimulate rapid healing and improve outcomes of standard of care burn treatments:

  • Time to 100% healing and time to complete wound closure (skin re-epithelialization without drainage or dressing requirements confirmed at study visits wound remained closed for at least 14 days)
  • Length of hospital stay
  • Time for return to full activity clinical wound measurement with respect to wound surface area and need for reoperation.
  • Monitoring improvement of scar appearance.
  • Assessment of wound flora, dermal collagen and elastin content, and epithelialization using tissue markers.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arteriocyte, Inc.

Collaborators

United States Department of Defense

Investigators

  • Study Director: Brian R. Barnes, PhD, Arteriocyte, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

April 25, 2013

First Submitted That Met QC Criteria

April 26, 2013

First Posted (Estimate)

May 1, 2013

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-11-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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