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Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT00856934
First received: January 2, 2009
Last updated: February 5, 2009
Last verified: February 2009
History of Changes

January 2, 2009
February 5, 2009
June 2005
March 2006   (final data collection date for primary outcome measure)
Complete Wound Healing [ Time Frame: Post operative day 5 and every other day thereafter ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00856934 on ClinicalTrials.gov Archive Site
Pain [ Time Frame: Post operative day 5 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing
A New Model to Enhance Wound Healing Using Autologous Keratinocytes in Platelet Concentrates - a Prospective Randomized Trial.

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Skin Graft
  • 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.
  • No Intervention: Control
    Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
    Intervention: Other: Standard dressings
  • Experimental: PRP
    PRP sprayed onto the wound bed with Calcium Choride. Wounds covered with same standard dressings used in control group.
    Interventions:
    • Biological: Autologous Platelet Rich Plasma
    • Other: Standard dressings
  • 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.
    Interventions:
    • Biological: Autologous Platelet Rich Plasma
    • Biological: Keratinocyte suspension
    • Other: Standard dressings

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
Not Provided
March 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00856934
132/03
No
Wassim Raffoul / Medecin Chef, Service de Chirurgie Plastique et Reconstructrice, CHUV
Centre Hospitalier Universitaire Vaudois
Not Provided
Principal Investigator: Wassim Raffoul, PD, MER CHUV - CPR
Centre Hospitalier Universitaire Vaudois
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP