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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Saline Gel, Standard of Care | Placebo Comparator | Normlgel Saline is placed on the excised wound bed prior to application of split thickness autograft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magellan® | Device | Autologous Platelet Rich Plasma Prepared Using the Magellan System |
|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of a composite of wound healing measurements | This treatment is intended to stimulate rapid healing and improve outcomes of standard of care burn treatments:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian R. Barnes, PhD | Arteriocyte, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis, Division of Burn Surgery | Sacramento | California | 95817 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21042116 | Background | 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. | |
| 21470370 |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Placebo Saline Gel and Usual and Customary Standard of Care | Other |
|
| 12 Months |
| Medstar Health Research Institute |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| 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. |
| 9589248 | 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. |
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| 18376156 | 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. |
| 11076319 | 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. |
| 19317995 | 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. |
| 18615157 | 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. |
| 16614255 | 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. |
| 18703188 | 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. |
| 19882589 | 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. |
| 19541423 | 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. |
| 10406801 | 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. |