Platelet-Rich Plasma Clinical Trial
Official title:
The Influence of Autologous Platelet Concentrates on Human Keratinocyte Proliferation in Vitro and Wound Healing in Vivo
NCT number | NCT03667638 |
Other study ID # | #1055-2011 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | December 2017 |
Verified date | September 2018 |
Source | Hannover Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic soft tissues defects can extend into the fat layer or even deeper and can cause functional disadvantages. Split-thickness skin grafts (STSGs) used to cover these wounds have varying success rates. To improve wound healing in chronic wounds the authors have studied the application of autologous platelet concentrates in a human keratinocyte culture model in vitro and in a combination with surgical procedures in vivo as second line therapy in patients with initially failed wound closure.
Status | Completed |
Enrollment | 5 |
Est. completion date | December 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - exposed tendons, ligaments or bone for >3 weeks - no healing tendency Exclusion Criteria: - sepsis - intensive care treatment - continuous smoking - pregnancy or breast feeding women - participants of other studies. |
Country | Name | City | State |
---|---|---|---|
Germany | Medical School Hannover | Hannover | Niedersachsen |
Lead Sponsor | Collaborator |
---|---|
Hannover Medical School |
Germany,
Achora S, Muliira JK, Thanka AN. Strategies to promote healing of split thickness skin grafts: an integrative review. J Wound Ostomy Continence Nurs. 2014 Jul-Aug;41(4):335-9; quiz E1-2. doi: 10.1097/WON.0000000000000035. Review. — View Citation
Alsousou J, Thompson M, Hulley P, Noble A, Willett K. The biology of platelet-rich plasma and its application in trauma and orthopaedic surgery: a review of the literature. J Bone Joint Surg Br. 2009 Aug;91(8):987-96. doi: 10.1302/0301-620X.91B8.22546. Review. — View Citation
Amable PR, Carias RB, Teixeira MV, da Cruz Pacheco I, Corrêa do Amaral RJ, Granjeiro JM, Borojevic R. Platelet-rich plasma preparation for regenerative medicine: optimization and quantification of cytokines and growth factors. Stem Cell Res Ther. 2013 Jun 7;4(3):67. doi: 10.1186/scrt218. — View Citation
Anitua E, Aguirre JJ, Algorta J, Ayerdi E, Cabezas AI, Orive G, Andia I. Effectiveness of autologous preparation rich in growth factors for the treatment of chronic cutaneous ulcers. J Biomed Mater Res B Appl Biomater. 2008 Feb;84(2):415-21. — View Citation
Appel TR, Pötzsch B, Müller J, von Lindern JJ, Bergé SJ, Reich RH. Comparison of three different preparations of platelet concentrates for growth factor enrichment. Clin Oral Implants Res. 2002 Oct;13(5):522-8. — View Citation
Asadi M, Alamdari DH, Rahimi HR, Aliakbarian M, Jangjoo A, Abdollahi A, Bahar MM, Azadmand A, Forghani N, Sadegh MN, Khayamy ME, Seifalian A. Treatment of life-threatening wounds with a combination of allogenic platelet-rich plasma, fibrin glue and collagen matrix, and a literature review. Exp Ther Med. 2014 Aug;8(2):423-429. Epub 2014 May 29. — View Citation
Barrientos S, Stojadinovic O, Golinko MS, Brem H, Tomic-Canic M. Growth factors and cytokines in wound healing. Wound Repair Regen. 2008 Sep-Oct;16(5):585-601. doi: 10.1111/j.1524-475X.2008.00410.x. Review. — View Citation
Behm B, Babilas P, Landthaler M, Schreml S. Cytokines, chemokines and growth factors in wound healing. J Eur Acad Dermatol Venereol. 2012 Jul;26(7):812-20. doi: 10.1111/j.1468-3083.2011.04415.x. Epub 2011 Dec 26. Review. — View Citation
Berg L, Meyer S, Ipaktchi R, Vogt PM, Müller A, de Zwaan M. [Psychosocial Distress at Different Time Intervals after Burn Injury]. Psychother Psychosom Med Psychol. 2017 Jun;67(6):231-239. doi: 10.1055/s-0042-111006. Epub 2016 Sep 29. German. — View Citation
Blome C, Baade K, Debus ES, Price P, Augustin M. The "Wound-QoL": a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193. — View Citation
Burnouf T, Tseng YH, Kuo YP, Su CY. Solvent/detergent treatment of platelet concentrates enhances the release of growth factors. Transfusion. 2008 Jun;48(6):1090-8. doi: 10.1111/j.1537-2995.2008.01691.x. Epub 2008 Mar 25. — View Citation
Carmeliet P, Jain RK. Molecular mechanisms and clinical applications of angiogenesis. Nature. 2011 May 19;473(7347):298-307. doi: 10.1038/nature10144. Review. — View Citation
Carter CA, Jolly DG, Worden CE Sr, Hendren DG, Kane CJ. Platelet-rich plasma gel promotes differentiation and regeneration during equine wound healing. Exp Mol Pathol. 2003 Jun;74(3):244-55. — View Citation
Cho JW, Kim SA, Lee KS. Platelet-rich plasma induces increased expression of G1 cell cycle regulators, type I collagen, and matrix metalloproteinase-1 in human skin fibroblasts. Int J Mol Med. 2012 Jan;29(1):32-6. doi: 10.3892/ijmm.2011.803. Epub 2011 Sep 30. — View Citation
Cohn CS, Lockhart E. Autologous platelet-rich plasma: evidence for clinical use. Curr Opin Hematol. 2015 Nov;22(6):527-32. doi: 10.1097/MOH.0000000000000183. Review. — View Citation
Danielsen P, Jørgensen B, Karlsmark T, Jorgensen LN, Agren MS. Effect of topical autologous platelet-rich fibrin versus no intervention on epithelialization of donor sites and meshed split-thickness skin autografts: a randomized clinical trial. Plast Reconstr Surg. 2008 Nov;122(5):1431-40. doi: 10.1097/PRS.0b013e318188202c. — View Citation
Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plast Reconstr Surg. 2004 Nov;114(6):1502-8. — View Citation
Gilliver SC, Ashworth JJ, Ashcroft GS. The hormonal regulation of cutaneous wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):56-62. Review. — View Citation
Gould L, Abadir P, Brem H, Carter M, Conner-Kerr T, Davidson J, DiPietro L, Falanga V, Fife C, Gardner S, Grice E, Harmon J, Hazzard WR, High KP, Houghton P, Jacobson N, Kirsner RS, Kovacs EJ, Margolis D, McFarland Horne F, Reed MJ, Sullivan DH, Thom S, Tomic-Canic M, Walston J, Whitney JA, Williams J, Zieman S, Schmader K. Chronic wound repair and healing in older adults: current status and future research. J Am Geriatr Soc. 2015 Mar;63(3):427-38. doi: 10.1111/jgs.13332. Epub 2015 Mar 6. — View Citation
House SL. Psychological distress and its impact on wound healing: an integrative review. J Wound Ostomy Continence Nurs. 2015 Jan-Feb;42(1):38-41. doi: 10.1097/WON.0000000000000080. Review. — View Citation
Kaltalioglu K, Coskun-Cevher S. A bioactive molecule in a complex wound healing process: platelet-derived growth factor. Int J Dermatol. 2015 Aug;54(8):972-7. doi: 10.1111/ijd.12731. Epub 2014 Oct 14. Review. — View Citation
Kawase T. Platelet-rich plasma and its derivatives as promising bioactive materials for regenerative medicine: basic principles and concepts underlying recent advances. Odontology. 2015 May;103(2):126-35. doi: 10.1007/s10266-015-0209-2. Epub 2015 Jun 4. Review. — View Citation
Khatib M, Jabir S, Fitzgerald O'Connor E, Philp B. A systematic review of the evolution of laser Doppler techniques in burn depth assessment. Plast Surg Int. 2014;2014:621792. doi: 10.1155/2014/621792. Epub 2014 Aug 7. Review. — View Citation
Kim SA, Ryu HW, Lee KS, Cho JW. Application of platelet-rich plasma accelerates the wound healing process in acute and chronic ulcers through rapid migration and upregulation of cyclin A and CDK4 in HaCaT cells. Mol Med Rep. 2013 Feb;7(2):476-80. doi: 10.3892/mmr.2012.1230. Epub 2012 Dec 12. — View Citation
Limbourg A, Korff T, Napp LC, Schaper W, Drexler H, Limbourg FP. Evaluation of postnatal arteriogenesis and angiogenesis in a mouse model of hind-limb ischemia. Nat Protoc. 2009;4(12):1737-46. doi: 10.1038/nprot.2009.185. Epub 2009 Nov 5. — View Citation
Mammoto T, Jiang A, Jiang E, Mammoto A. Platelet rich plasma extract promotes angiogenesis through the angiopoietin1-Tie2 pathway. Microvasc Res. 2013 Sep;89:15-24. doi: 10.1016/j.mvr.2013.04.008. Epub 2013 May 6. — View Citation
Martinez-Zapata MJ, Martí-Carvajal AJ, Solà I, Expósito JA, Bolíbar I, Rodríguez L, Garcia J. Autologous platelet-rich plasma for treating chronic wounds. Cochrane Database Syst Rev. 2012 Oct 17;10:CD006899. doi: 10.1002/14651858.CD006899.pub2. Review. Update in: Cochrane Database Syst Rev. 2016;(5):CD006899. — View Citation
Mazzucco L, Borzini P, Gope R. Platelet-derived factors involved in tissue repair-from signal to function. Transfus Med Rev. 2010 Jul;24(3):218-34. doi: 10.1016/j.tmrv.2010.03.004. Review. — View Citation
Nurden AT, Nurden P, Sanchez M, Andia I, Anitua E. Platelets and wound healing. Front Biosci. 2008 May 1;13:3532-48. Review. — View Citation
Okuda K, Kawase T, Momose M, Murata M, Saito Y, Suzuki H, Wolff LF, Yoshie H. Platelet-rich plasma contains high levels of platelet-derived growth factor and transforming growth factor-beta and modulates the proliferation of periodontally related cells in vitro. J Periodontol. 2003 Jun;74(6):849-57. — View Citation
Paul DW, Ghassemi P, Ramella-Roman JC, Prindeze NJ, Moffatt LT, Alkhalil A, Shupp JW. Noninvasive imaging technologies for cutaneous wound assessment: A review. Wound Repair Regen. 2015 Mar-Apr;23(2):149-62. doi: 10.1111/wrr.12262. Review. — View Citation
Reinke JM, Sorg H. Wound repair and regeneration. Eur Surg Res. 2012;49(1):35-43. doi: 10.1159/000339613. Epub 2012 Jul 11. Review. — View Citation
Robson MC, Maggi SP, Smith PD, Wassermann RJ, Mosiello GC, Hill DP, Cooper DM. Original articles: ease of wound closure as an endpoint of treatment efficacy. Wound Repair Regen. 1999 Mar-Apr;7(2):90-6. — View Citation
Shaw TJ, Martin P. Wound repair at a glance. J Cell Sci. 2009 Sep 15;122(Pt 18):3209-13. doi: 10.1242/jcs.031187. Review. — View Citation
Weibrich G, Kleis WK, Hafner G, Hitzler WE, Wagner W. Comparison of platelet, leukocyte, and growth factor levels in point-of-care platelet-enriched plasma, prepared using a modified Curasan kit, with preparations received from a local blood bank. Clin Oral Implants Res. 2003 Jun;14(3):357-62. — View Citation
Weibrich G, Kleis WK. Curasan PRP kit vs. PCCS PRP system. Collection efficiency and platelet counts of two different methods for the preparation of platelet-rich plasma. Clin Oral Implants Res. 2002 Aug;13(4):437-43. — View Citation
Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. Review. — View Citation
Xian LJ, Chowdhury SR, Bin Saim A, Idrus RB. Concentration-dependent effect of platelet-rich plasma on keratinocyte and fibroblast wound healing. Cytotherapy. 2015 Mar;17(3):293-300. doi: 10.1016/j.jcyt.2014.10.005. Epub 2014 Nov 21. — View Citation
* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound Closure | Area of wound closure in % compared to initial size | 4 weeks | |
Secondary | Blood Flow | Blood flow measured in wound margins and wound bed compared to regular skin measured using Laser Doppler Imaging | 4 weeks | |
Secondary | Wound Quality of Life | Quality of patients' life measured using Wound-QoL® Questionnaire before and after Intervention. Seventeen items are included in the Wound-QoL, which could be attributed to three subscales on everyday life, body, and psyche. The paper presents the overall score. A higher value correlates with more wound related burden, meaning a lower value indicates higher qulitiy of life. More information: https://www.ncbi.nlm.nih.gov/pubmed/24899053 |
21 days | |
Secondary | Ease of surgical wound closure | Estimated ease of surgical wound closure. The patients`wound was discussed by at least two surgeons to obtain agreement on a 14- point "Ease of Closure" scale. This was done on day 0 as well as day 21. The scale ranged from a score of 0, meaning the wound was closed or so small as to require no closure technique, to a score of 13, meaning that it was not possible to close the wound with known reconstructive surgical techniques. A higher value therefore correlates with more complex surgery. More information: https://www.ncbi.nlm.nih.gov/pubmed/10231510 |
21 days |
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