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

NCT01843686 | Unknown Phase 1 DMC

• 1 other identifier: ART-11-004
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acute Burns

Keywords

Acute 2nd and 3rd Degree Burns; Autologous Platelet Rich Plasma (PRP); Skin Grafting; Magellan® System; Wounds

Outcome Measures

Primary Outcomes (1)

• Demonstrate the safety of application of autologous platelet rich plasma (PRP) gel following excision of an acute deep 2nd and 3rd degree burn.

  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 Outcomes (1)

• Assessment of a composite of wound healing measurements

  12 Months

Study Arms (2)

Autologous Platelet Rich Plasma (PRP)

EXPERIMENTAL

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®

Saline Gel, Standard of Care

PLACEBO COMPARATOR

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

Interventions

Magellan® DEVICE

Autologous Platelet Rich Plasma Prepared Using the Magellan System

Also known as: Autologous Platelet Rich Plasma

Autologous Platelet Rich Plasma (PRP)

Placebo Saline Gel and Usual and Customary Standard of Care OTHER

Saline Gel, 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:

• 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)

You may not qualify if:

• 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:

Sponsors & Collaborators

• Arteriocyte, Inc.: lead
• United States Department of Defense: collaborator

Study Sites (3)

University of California, Davis, Division of Burn Surgery

Sacramento, California, 95817, United States

Location

Medstar Health Research Institute

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

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Related Publications (15)

• Bush J, Duncan JAL, Bond JS, Durani P, So K, Mason T, O'Kane S, Ferguson MWJ. Scar-improving efficacy of avotermin administered into the wound margins of skin incisions as evaluated by a randomized, double-blind, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2010 Nov;126(5):1604-1615. doi: 10.1097/PRS.0b013e3181ef8e66.

  PMID: 21042116 BACKGROUND

• Saad Setta H, Elshahat A, Elsherbiny K, Massoud K, Safe I. Platelet-rich plasma versus platelet-poor plasma in the management of chronic diabetic foot ulcers: a comparative study. Int Wound J. 2011 Jun;8(3):307-12. doi: 10.1111/j.1742-481X.2011.00797.x. Epub 2011 Apr 7.

  PMID: 21470370 BACKGROUND

• Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998 May;21(5):822-7. doi: 10.2337/diacare.21.5.822.

  PMID: 9589248 BACKGROUND

• Badiavas EV, Abedi M, Butmarc J, Falanga V, Quesenberry P. Participation of bone marrow derived cells in cutaneous wound healing. J Cell Physiol. 2003 Aug;196(2):245-50. doi: 10.1002/jcp.10260.

  PMID: 12811816 BACKGROUND

• Milkiewicz M, Ispanovic E, Doyle JL, Haas TL. Regulators of angiogenesis and strategies for their therapeutic manipulation. Int J Biochem Cell Biol. 2006 Mar;38(3):333-57. doi: 10.1016/j.biocel.2005.10.006. Epub 2005 Nov 7.

  PMID: 16309946 BACKGROUND

• Lee JA, Conejero JA, Mason JM, Parrett BM, Wear-Maggitti KD, Grant RT, Breitbart AS. Lentiviral transfection with the PDGF-B gene improves diabetic wound healing. Plast Reconstr Surg. 2005 Aug;116(2):532-8. doi: 10.1097/01.prs.0000172892.78964.49.

  PMID: 16079687 BACKGROUND

• Renz EM, Cancio LC, Barillo DJ, White CE, Albrecht MC, Thompson CK, Ennis JL, Wanek SM, King JA, Chung KK, Wolf SE, Holcomb JB. Long range transport of war-related burn casualties. J Trauma. 2008 Feb;64(2 Suppl):S136-44; discussion S144-5. doi: 10.1097/TA.0b013e31816086c9.

  PMID: 18376156 BACKGROUND

• Kalka C, Asahara T, Krone W, Isner JM. [Angiogenesis and vasculogenesis. Therapeutic strategies for stimulation of postnatal neovascularization]. Herz. 2000 Sep;25(6):611-22. doi: 10.1007/pl00001974. German.

  PMID: 11076319 BACKGROUND

• Gomez R, Murray CK, Hospenthal DR, Cancio LC, Renz EM, Holcomb JB, Wade CE, Wolf SE. Causes of mortality by autopsy findings of combat casualties and civilian patients admitted to a burn unit. J Am Coll Surg. 2009 Mar;208(3):348-54. doi: 10.1016/j.jamcollsurg.2008.11.012. Epub 2009 Jan 21.

  PMID: 19317995 BACKGROUND

• Schwacha MG, Nickel E, Daniel T. Burn injury-induced alterations in wound inflammation and healing are associated with suppressed hypoxia inducible factor-1alpha expression. Mol Med. 2008 Sep-Oct;14(9-10):628-33. doi: 10.2119/2008-00069.Schwacha.

  PMID: 18615157 BACKGROUND

• Church D, Elsayed S, Reid O, Winston B, Lindsay R. Burn wound infections. Clin Microbiol Rev. 2006 Apr;19(2):403-34. doi: 10.1128/CMR.19.2.403-434.2006.

  PMID: 16614255 BACKGROUND

• Kazakos K, Lyras DN, Verettas D, Tilkeridis K, Tryfonidis M. The use of autologous PRP gel as an aid in the management of acute trauma wounds. Injury. 2009 Aug;40(8):801-5. doi: 10.1016/j.injury.2008.05.002. Epub 2008 Aug 13.

  PMID: 18703188 BACKGROUND

• Marquez De Aracena Del Cid R, Montero De Espinosa Escoriaza I. Subconjunctival application of regenerative factor-rich plasma for the treatment of ocular alkali burns. Eur J Ophthalmol. 2009 Nov-Dec;19(6):909-15. doi: 10.1177/112067210901900603.

  PMID: 19882589 BACKGROUND

• Pallua N, Wolter T, Markowicz M. Platelet-rich plasma in burns. Burns. 2010 Feb;36(1):4-8. doi: 10.1016/j.burns.2009.05.002. Epub 2009 Jun 21.

  PMID: 19541423 BACKGROUND

• Asahara T, Takahashi T, Masuda H, Kalka C, Chen D, Iwaguro H, Inai Y, Silver M, Isner JM. VEGF contributes to postnatal neovascularization by mobilizing bone marrow-derived endothelial progenitor cells. EMBO J. 1999 Jul 15;18(14):3964-72. doi: 10.1093/emboj/18.14.3964.

  PMID: 10406801 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Brian R. Barnes, PhD

  Arteriocyte, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: May 1, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

US (3)