Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IDE 15921 | Other Identifier | Center for Biologics Evaluation and Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Department of Health and Human Services | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The objective of this trial is to demonstrate the safety of applying autologous PRP gel (Magellan® Bio-Bandage™) to acute deep partial thickness thermal burns in the first days after burn injury.
The Magellan® Bio-Bandage™ Burn Wound Care Kit is intended for the preparation and application of an autologous biological covering to deep partial thickness burn wounds to delay or minimize skin grafting requirements.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Rich Plasma - Bio-Bandage™ | Experimental | Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) |
|
| Saline Spray, Standard of Care | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Delay or minimization of skin grafting requirements following burn injury | This outcome will be evaluated by time to graft (days), need for graft (yes or no), and incidence of graft occurrence ( percentage of subjects in control group versus treatment group requiring a skin graft). | Change will be assessed up to 35 Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Barnes, PhD | Arteriocyte, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Burn Center | Phoenix | Arizona | 85008 | United States | ||
| University of California, Davis Medica Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21854302 | Background | Badiavas AR, Badiavas EV. Potential benefits of allogeneic bone marrow mesenchymal stem cells for wound healing. Expert Opin Biol Ther. 2011 Nov;11(11):1447-54. doi: 10.1517/14712598.2011.606212. Epub 2011 Aug 20. | |
| 7669196 | Background | Barr JE. Principles of wound cleansing. Ostomy Wound Manage. 1995 Aug;41(7A Suppl):15S-21S; discussion 22S. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Improved wound healing trajectory as compared to standard of care |
Wound healing will be assessed by calculating wound size measurements and percentage of change over time utilizing digital photography and planimetry software. |
| Change will be assessed up to 365 Days |
| Increased rate of wound closure as compared to standard of care | The percentage of treated subjects versus standard of care only subjects with complete wound closure at 28 and 42 days post-burn injury. Wound closure will be defined as skin re-epithelialization without drainage or dressing requirements confirmed at two consecutive visits. | Change will be assessed up to 365 Days |
| Reduced scarring, pain and pruritus | This outcome will compare treated subjects to standard of care only subjects by analyzing photo images and scar scale analysis (principal investigator and blinded rater assessments), and based on subject reported pain and pruritus. | Change will be assessed up to 365 Days |
| Improved Skin-Healing Quality | Histological analysis of 2mm skin biopsies taken at Baseline (Day 1) and 90 days post-treatment will be analyzed and compared. Biopsies will be taken only from subject for whom a skin graft was not required, and from both treated subjects and standard of care only subjects. | Change will be assessed up to 365 Days |
| Sacramento |
| California |
| 95817 |
| United States |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Tampa General Hospital/University of South Florida | Tampa | Florida | 33606 | United States |
| University Medical Center Southern Nevada, Lions Regional Burn Center | Las Vegas | Nevada | 89102 | United States |
| Jaycee Burn Center at University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Firefighters' Regional Burn Center | Memphis | Tennessee | 38104 | United States |
| 20634084 | Background | Almdahl SM, Veel T, Halvorsen P, Vold MB, Molstad P. Randomized prospective trial of saphenous vein harvest site infection after wound closure with and without topical application of autologous platelet-rich plasma. Eur J Cardiothorac Surg. 2011 Jan;39(1):44-8. doi: 10.1016/j.ejcts.2010.06.007. Epub 2010 Jul 15. |
| 17356164 | Background | Bielecki TM, Gazdzik TS, Arendt J, Szczepanski T, Krol W, Wielkoszynski T. Antibacterial effect of autologous platelet gel enriched with growth factors and other active substances: an in vitro study. J Bone Joint Surg Br. 2007 Mar;89(3):417-20. doi: 10.1302/0301-620X.89B3.18491. |
| 22284405 | Background | Boswell SG, Cole BJ, Sundman EA, Karas V, Fortier LA. Platelet-rich plasma: a milieu of bioactive factors. Arthroscopy. 2012 Mar;28(3):429-39. doi: 10.1016/j.arthro.2011.10.018. Epub 2012 Jan 28. |
| 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. |
| 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. |
| 16172284 | Background | Dib N, Michler RE, Pagani FD, Wright S, Kereiakes DJ, Lengerich R, Binkley P, Buchele D, Anand I, Swingen C, Di Carli MF, Thomas JD, Jaber WA, Opie SR, Campbell A, McCarthy P, Yeager M, Dilsizian V, Griffith BP, Korn R, Kreuger SK, Ghazoul M, MacLellan WR, Fonarow G, Eisen HJ, Dinsmore J, Diethrich E. Safety and feasibility of autologous myoblast transplantation in patients with ischemic cardiomyopathy: four-year follow-up. Circulation. 2005 Sep 20;112(12):1748-55. doi: 10.1161/CIRCULATIONAHA.105.547810. |
| 16151021 | Background | Erbs S, Linke A, Adams V, Lenk K, Thiele H, Diederich KW, Emmrich F, Kluge R, Kendziorra K, Sabri O, Schuler G, Hambrecht R. Transplantation of blood-derived progenitor cells after recanalization of chronic coronary artery occlusion: first randomized and placebo-controlled study. Circ Res. 2005 Oct 14;97(8):756-62. doi: 10.1161/01.RES.0000185811.71306.8b. Epub 2005 Sep 8. |
| 21792775 | Background | Farrior E, Ladner K. Platelet gels and hemostasis in facial plastic surgery. Facial Plast Surg. 2011 Aug;27(4):308-14. doi: 10.1055/s-0031-1283050. Epub 2011 Jul 26. |
| 20596233 | Background | Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43. |
| 21200219 | Background | Fearmonti RM, Bond JE, Erdmann D, Levin LS, Pizzo SV, Levinson H. The modified Patient and Observer Scar Assessment Scale: a novel approach to defining pathologic and nonpathologic scarring. Plast Reconstr Surg. 2011 Jan;127(1):242-247. doi: 10.1097/PRS.0b013e3181f959e8. |
| 12952828 | Background | Forrester JS, Price MJ, Makkar RR. Stem cell repair of infarcted myocardium: an overview for clinicians. Circulation. 2003 Sep 2;108(9):1139-45. doi: 10.1161/01.CIR.0000085305.82019.65. No abstract available. |
| 19029269 | Background | Gunaydin S, McCusker K, Sari T, Onur M, Gurpinar A, Sevim H, Atasoy P, Yorgancioglu C, Zorlutuna Y. Clinical impact and biomaterial evaluation of autologous platelet gel in cardiac surgery. Perfusion. 2008 May;23(3):179-86. doi: 10.1177/0267659108097783. |
| 22009148 | Background | Jorgensen B, Karlsmark T, Vogensen H, Haase L, Lundquist R. A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds. Int J Low Extrem Wounds. 2011 Dec;10(4):218-23. doi: 10.1177/1534734611426755. Epub 2011 Oct 18. |
| 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. |
| 22078803 | Background | Keck M, Selig HF, Lumenta DB, Kamolz LP, Mittlbock M, Frey M. The use of Suprathel((R)) in deep dermal burns: first results of a prospective study. Burns. 2012 May;38(3):388-95. doi: 10.1016/j.burns.2011.09.026. Epub 2011 Nov 10. |
| 18585051 | Background | Khalafi RS, Bradford DW, Wilson MG. Topical application of autologous blood products during surgical closure following a coronary artery bypass graft. Eur J Cardiothorac Surg. 2008 Aug;34(2):360-4. doi: 10.1016/j.ejcts.2008.04.026. Epub 2008 Jun 26. |
| 22688194 | Background | Lee H. Outcomes of sprayed cultured epithelial autografts for full-thickness wounds: a single-centre experience. Burns. 2012 Sep;38(6):931-6. doi: 10.1016/j.burns.2012.01.014. Epub 2012 Jun 9. |
| 21470370 | 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. |
| 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. |
| 23692143 | Background | Serraino GF, Dominijanni A, Jiritano F, Rossi M, Cuda A, Caroleo S, Brescia A, Renzulli A. Platelet-rich plasma inside the sternotomy wound reduces the incidence of sternal wound infections. Int Wound J. 2015 Jun;12(3):260-4. doi: 10.1111/iwj.12087. Epub 2013 May 21. |
| 2373734 | Background | Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014. |
| 16524157 | Background | Trowbridge CC, Stammers AH, Woods E, Yen BR, Klayman M, Gilbert C. Use of platelet gel and its effects on infection in cardiac surgery. J Extra Corpor Technol. 2005 Dec;37(4):381-6. |
| 16441599 | Background | Valeri CR, Saleem B, Ragno G. Release of platelet-derived growth factors and proliferation of fibroblasts in the releasates from platelets stored in the liquid state at 22 degrees C after stimulation with agonists. Transfusion. 2006 Feb;46(2):225-9. doi: 10.1111/j.1537-2995.2006.00705.x. |
| 24252249 | Background | Wolf SE, Arnoldo BD. The year in burns 2012. Burns. 2013 Dec;39(8):1501-13. doi: 10.1016/j.burns.2013.11.001. Epub 2013 Nov 16. |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided