NCT00856934

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

March 6, 2009

Completed
Last Updated

March 6, 2009

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

January 2, 2009

Results QC Date

January 2, 2009

Last Update Submit

February 5, 2009

Conditions

Skin Graft

Keywords

Skin graft donor site healingskinwoundplatelet concentratekeratinocytesburns

Outcome Measures

Primary Outcomes (1)

  • Complete Wound Healing

    Time required for complete epithelialization in days

    Post operative day 5 and every other day thereafter

Secondary Outcomes (1)

  • Pain

    Post operative day 5

Study Arms (3)

Control

NO INTERVENTION

Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.

Other: Standard dressings

PRP

EXPERIMENTAL

PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.

Biological: Autologous Platelet Rich PlasmaOther: Standard dressings

PRP+K

EXPERIMENTAL

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 PlasmaBiological: Keratinocyte suspensionOther: Standard dressings

Interventions

Autologous Platelet Rich PlasmaBIOLOGICAL

Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion.

PRPPRP+K
Keratinocyte suspensionBIOLOGICAL

Autologous keratinocytes isolated from skin biopsy suspended in platelet rich plasma before spraying.

PRP+K
Standard dressingsOTHER

Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.

ControlPRPPRP+K

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (32)

  • 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. doi: 10.1111/j.1067-1927.2005.130202.x.

    PMID: 15828936BACKGROUND

  • 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. doi: 10.1172/JCI116636.

    PMID: 8349805BACKGROUND

  • 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. doi: 10.1111/1523-1747.ep12613450.

    PMID: 7798644BACKGROUND

  • 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. doi: 10.1084/jem.176.5.1375.

    PMID: 1402682BACKGROUND

  • 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. doi: 10.1242/jcs.114.4.811.

    PMID: 11171386BACKGROUND

  • Feliciani C, Gupta AK, Sauder DN. Keratinocytes and cytokine/growth factors. Crit Rev Oral Biol Med. 1996;7(4):300-18. doi: 10.1177/10454411960070040101.

    PMID: 8986393BACKGROUND

  • McKay IA, Leigh IM. Epidermal cytokines and their roles in cutaneous wound healing. Br J Dermatol. 1991 Jun;124(6):513-8. doi: 10.1111/j.1365-2133.1991.tb04942.x.

    PMID: 2064935BACKGROUND

  • Tamariz-Dominguez E, Castro-Munozledo 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. doi: 10.1007/s004410100450. Epub 2001 Nov 14.

    PMID: 11810316BACKGROUND

  • 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. doi: 10.1016/s0014-4800(03)00017-0.

    PMID: 12782011BACKGROUND

  • 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. doi: 10.1097/00000658-198609000-00011.

    PMID: 3753059BACKGROUND

  • 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. doi: 10.1111/j.1537-2995.2004.03366.x.

    PMID: 15225241BACKGROUND

  • 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. doi: 10.1177/039139880202500413.

    PMID: 12027145BACKGROUND

  • 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. doi: 10.1097/00020840-200308000-00005.

    PMID: 14515071BACKGROUND

  • Feldman DL. Which dressing for split-thickness skin graft donor sites? Ann Plast Surg. 1991 Sep;27(3):288-91. doi: 10.1097/00000637-199109000-00017.

    PMID: 1952757BACKGROUND

  • 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. doi: 10.2174/1381612013397573.

    PMID: 11472255BACKGROUND

  • Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. doi: 10.1152/physrev.2003.83.3.835.

    PMID: 12843410BACKGROUND

  • 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. doi: 10.1016/0024-3205(82)90492-1.

    PMID: 7098767BACKGROUND

  • Atiyeh BS, Gunn SW, Hayek SN. State of the art in burn treatment. World J Surg. 2005 Feb;29(2):131-48. doi: 10.1007/s00268-004-1082-2.

    PMID: 15654666BACKGROUND

  • Hierner R, Degreef H, Vranckx JJ, Garmyn M, Massage P, van Brussel M. Skin grafting and wound healing-the "dermato-plastic team approach". Clin Dermatol. 2005 Jul-Aug;23(4):343-52. doi: 10.1016/j.clindermatol.2004.07.028.

    PMID: 16023929BACKGROUND

  • Eaglstein WH, Falanga V. Chronic wounds. Surg Clin North Am. 1997 Jun;77(3):689-700. doi: 10.1016/s0039-6109(05)70575-2.

    PMID: 9194887BACKGROUND

  • Edwards R, Harding KG. Bacteria and wound healing. Curr Opin Infect Dis. 2004 Apr;17(2):91-6. doi: 10.1097/00001432-200404000-00004.

    PMID: 15021046BACKGROUND

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

    PMID: 2199139BACKGROUND

  • Smith DJ Jr, Thomson PD, Garner WL, Rodriguez JL. Donor site repair. Am J Surg. 1994 Jan;167(1A):49S-51S. doi: 10.1016/0002-9610(94)90012-4.

    PMID: 8109686BACKGROUND

  • 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. doi: 10.1016/s0305-4179(01)00015-8.

    PMID: 11525858RESULT

  • 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. doi: 10.1097/01.sap.0000112349.42549.b3.

    PMID: 15269581RESULT

  • 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. doi: 10.1046/j.1322-7114.2003.00417.x.

    PMID: 12694482RESULT

  • 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. doi: 10.1097/00004630-199301000-00006.

    PMID: 8454661RESULT

  • 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. doi: 10.1097/00000658-200201000-00020.

    PMID: 11753055RESULT

  • 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. doi: 10.1016/s0007-1226(03)00195-4.

    PMID: 12890465RESULT

  • 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. doi: 10.1016/s0897-1897(98)80296-6.

    PMID: 9852660RESULT

  • 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.

    PMID: 17356164RESULT

  • 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. doi: 10.1002/jor.20519.

    PMID: 17960651RESULT

MeSH Terms

Conditions

Wounds and InjuriesBurns

Results Point of Contact

Title
Dr. Wassim Raffoul
Organization
CHUV - CPR
Wassim.Raffoul@chuv.ch
+41 21 314 25 05

Study Officials

  • Wassim Raffoul, PD, MER

    CHUV - CPR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2009

First Posted

March 6, 2009

Study Start

June 1, 2005

Primary Completion

March 1, 2006

Last Updated

March 6, 2009

Results First Posted

March 6, 2009

Record last verified: 2009-02

Locations

CH(1)