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
  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.

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
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:

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 22, 2014