Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing - Full Text View

Purpose

This prospective randomized trial evaluated the impact of autologous keratinocytes suspended in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that the treatment would speed and improve wound healing.

Condition	Intervention	Phase
Skin Graft	Biological: Autologous Platelet Rich Plasma Biological: Keratinocyte suspension Other: Standard dressings	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A New Model to Enhance Wound Healing Using Autologous Keratinocytes in Platelet Concentrates - a Prospective Randomized Trial.

Resource links provided by NLM:

MedlinePlus related topics: Wounds and Injuries

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:

Complete Wound Healing [ Time Frame: Post operative day 5 and every other day thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain [ Time Frame: Post operative day 5 ] [ Designated as safety issue: No ]


Enrollment:	45
Study Start Date:	June 2005
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Control Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.	Other: Standard dressings Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.
Experimental: PRP PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.	Biological: Autologous Platelet Rich Plasma Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion. Other: Standard dressings Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.
Experimental: PRP+K Keratinocytes suspended in PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.	Biological: Autologous Platelet Rich Plasma Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion. Biological: Keratinocyte suspension Autologous keratinocytes isolated from skin biopsy suspended in platelet rich plasma before spraying. Other: Standard dressings Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Skin graft donor sites total surface < 15% BSA
Skin graft donor site size: 0.2mm deep, 30 to 40 cm2 surface area

Exclusion Criteria:

Patients treated with immunosuppressors
Patients treated with corticoids
Patients suffering from terminal renal insufficiency
Patients suffering from severe peripheral arteriopathy

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00856934

Locations


Switzerland
Centre hospitalier Universitaire Vaudois
Lausanne, Vaud, Switzerland, 1011

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

Investigators


Principal Investigator:	Wassim Raffoul, PD, MER	CHUV - CPR

More Information

Publications:

Innes ME, Umraw N, Fish JS, Gomez M, Cartotto RC. The use of silver coated dressings on donor site wounds: a prospective, controlled matched pair study. Burns. 2001 Sep;27(6):621-7.

Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg. 2004 Aug;53(2):132-6.

Wiechula R. The use of moist wound-healing dressings in the management of split-thickness skin graft donor sites: a systematic review. Int J Nurs Pract. 2003 Apr;9(2):S9-17. Review.

Greenhalgh DG, Barthel PP, Warden GD. Comparison of back versus thigh donor sites in pediatric patients with burns. J Burn Care Rehabil. 1993 Jan-Feb;14(1):21-5.

Hart DW, Wolf SE, Herndon DN, Chinkes DL, Lal SO, Obeng MK, Beauford RB, Mlcak RT RP. Energy expenditure and caloric balance after burn: increased feeding leads to fat rather than lean mass accretion. Ann Surg. 2002 Jan;235(1):152-61.

Hormbrey E, Pandya A, Giele H. Adhesive retention dressings are more comfortable than alginate dressings on split-skin-graft donor sites. Br J Plast Surg. 2003 Jul;56(5):498-503.

Rakel BA, Bermel MA, Abbott LI, Baumler SK, Burger MR, Dawson CJ, Heinle JA, Ocheltree IM. Split-thickness skin graft donor site care: a quantitative synthesis of the research. Appl Nurs Res. 1998 Nov;11(4):174-82. Review.

Bielecki TM, Gazdzik TS, Arendt J, Szczepanski T, Król 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.

Moojen DJ, Everts PA, Schure RM, Overdevest EP, van Zundert A, Knape JT, Castelein RM, Creemers LB, Dhert WJ. Antimicrobial activity of platelet-leukocyte gel against Staphylococcus aureus. J Orthop Res. 2008 Mar;26(3):404-10.

Fu X, Li X, Cheng B, Chen W, Sheng Z. Engineered growth factors and cutaneous wound healing: success and possible questions in the past 10 years. Wound Repair Regen. 2005 Mar-Apr;13(2):122-30. Review.

Ansel JC, Tiesman JP, Olerud JE, Krueger JG, Krane JF, Tara DC, Shipley GD, Gilbertson D, Usui ML, Hart CE. Human keratinocytes are a major source of cutaneous platelet-derived growth factor. J Clin Invest. 1993 Aug;92(2):671-8.

Ballaun C, Weninger W, Uthman A, Weich H, Tschachler E. Human keratinocytes express the three major splice forms of vascular endothelial growth factor. J Invest Dermatol. 1995 Jan;104(1):7-10.

Brown LF, Yeo KT, Berse B, Yeo TK, Senger DR, Dvorak HF, van de Water L. Expression of vascular permeability factor (vascular endothelial growth factor) by epidermal keratinocytes during wound healing. J Exp Med. 1992 Nov 1;176(5):1375-9.

Decline F, Rousselle P. Keratinocyte migration requires alpha2beta1 integrin-mediated interaction with the laminin 5 gamma2 chain. J Cell Sci. 2001 Feb;114(Pt 4):811-23.

Feliciani C, Gupta AK, Sauder DN. Keratinocytes and cytokine/growth factors. Crit Rev Oral Biol Med. 1996;7(4):300-18. Review.

McKay IA, Leigh IM. Epidermal cytokines and their roles in cutaneous wound healing. Br J Dermatol. 1991 Jun;124(6):513-8. Review.

Tamariz-Domínguez E, Castro-Muñozledo F, Kuri-Harcuch W. Growth factors and extracellular matrix proteins during wound healing promoted with frozen cultured sheets of human epidermal keratinocytes. Cell Tissue Res. 2002 Jan;307(1):79-89. Epub 2001 Nov 14.

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.

Knighton DR, Ciresi KF, Fiegel VD, Austin LL, Butler EL. Classification and treatment of chronic nonhealing wounds. Successful treatment with autologous platelet-derived wound healing factors (PDWHF). Ann Surg. 1986 Sep;204(3):322-30.

Mazzucco L, Medici D, Serra M, Panizza R, Rivara G, Orecchia S, Libener R, Cattana E, Levis A, Betta PG, Borzini P. The use of autologous platelet gel to treat difficult-to-heal wounds: a pilot study. Transfusion. 2004 Jul;44(7):1013-8.

Valbonesi M, Giannini G, Migliori F, Dalla Costa R, Galli A. The role of autologous fibrin-platelet glue in plastic surgery: a preliminary report. Int J Artif Organs. 2002 Apr;25(4):334-8.

Brissett AE, Hom DB. The effects of tissue sealants, platelet gels, and growth factors on wound healing. Curr Opin Otolaryngol Head Neck Surg. 2003 Aug;11(4):245-50. Review.

Feldman DL. Which dressing for split-thickness skin graft donor sites? Ann Plast Surg. 1991 Sep;27(3):288-91. Review.

Gharaee-Kermani M, Phan SH. Role of cytokines and cytokine therapy in wound healing and fibrotic diseases. Curr Pharm Des. 2001 Jul;7(11):1083-103. Review.

Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. Review.

Di Giulio AM, Picotti GB, Cesura AM, Panerai AE, Mantegazza P. Met-enkephalin immunoreactivity in blood platelets. Life Sci. 1982 May 10;30(19):1605-14.

Atiyeh BS, Gunn SW, Hayek SN. State of the art in burn treatment. World J Surg. 2005 Feb;29(2):131-48. Review.

Hierner R, Degreef H, Vranckx JJ, Garmyn M, Massagé P, van Brussel M. Skin grafting and wound healing-the "dermato-plastic team approach". Clin Dermatol. 2005 Jul-Aug;23(4):343-52. Review.

Eaglstein WH, Falanga V. Chronic wounds. Surg Clin North Am. 1997 Jun;77(3):689-700. Review.

Edwards R, Harding KG. Bacteria and wound healing. Curr Opin Infect Dis. 2004 Apr;17(2):91-6. Review.

Robson MC, Stenberg BD, Heggers JP. Wound healing alterations caused by infection. Clin Plast Surg. 1990 Jul;17(3):485-92. Review.

Smith DJ Jr, Thomson PD, Garner WL, Rodriguez JL. Donor site repair. Am J Surg. 1994 Jan;167(1A):49S-51S. Review.


Responsible Party:	Wassim Raffoul / Medecin Chef, Service de Chirurgie Plastique et Reconstructrice, CHUV
ClinicalTrials.gov Identifier:	NCT00856934 History of Changes
Other Study ID Numbers:	132/03
Study First Received:	January 2, 2009
Results First Received:	January 2, 2009
Last Updated:	February 5, 2009
Health Authority:	Switzerland: Swissmedic

Keywords provided by Centre Hospitalier Universitaire Vaudois:


Skin graft donor site healing skin wound	platelet concentrate keratinocytes burns

ClinicalTrials.gov processed this record on September 26, 2016