Using Autologous Platelet Rich Plasma (PRP) Gel to Treat Deep 2nd and 3rd Degree Burns
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ClinicalTrials.gov Identifier: NCT01843686 |
Recruitment Status
:
Active, not recruiting
First Posted
: May 1, 2013
Last Update Posted
: January 9, 2018
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Condition or disease | Intervention/treatment | Phase |
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Acute Burns | Device: Magellan® Other: Placebo Saline Gel and Usual and Customary Standard of Care | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Use of Autologous Platelet Rich Plasma (PRP) Gel as an Adjunct to the Treatment of Deep 2nd and 3rd Degree Burns |
Actual Study Start Date : | April 2013 |
Estimated Primary Completion Date : | February 2018 |
Estimated Study Completion Date : | March 2018 |

Arm | Intervention/treatment |
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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.
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Device: Magellan®
Autologous Platelet Rich Plasma Prepared Using the Magellan System
Other Name: Autologous Platelet Rich Plasma
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Placebo Comparator: Saline Gel, Standard of Care
Normlgel Saline is placed on the excised wound bed prior to application of split thickness autograft.
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Other: Placebo Saline Gel and Usual and Customary Standard of Care |
- 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
- 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.

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Ages Eligible for Study: | 18 Years to 86 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843686
United States, California | |
University of California, Davis, Division of Burn Surgery | |
Sacramento, California, United States, 95817 | |
United States, District of Columbia | |
Medstar Health Research Institute | |
Washington, District of Columbia, United States, 20010 | |
United States, Utah | |
University of Utah Hospital | |
Salt Lake City, Utah, United States, 84132 |
Study Director: | Brian R. Barnes, PhD | Arteriocyte, Inc. |
Publications:
Responsible Party: | Arteriocyte, Inc. |
ClinicalTrials.gov Identifier: | NCT01843686 History of Changes |
Other Study ID Numbers: |
ART-11-004 |
First Posted: | May 1, 2013 Key Record Dates |
Last Update Posted: | January 9, 2018 |
Last Verified: | January 2018 |
Keywords provided by Arteriocyte, Inc.:
Acute 2nd and 3rd Degree Burns Autologous Platelet Rich Plasma (PRP) Skin Grafting Magellan® System Wounds |
Additional relevant MeSH terms:
Burns Wounds and Injuries |