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Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

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ClinicalTrials.gov Identifier: NCT00856934
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : March 6, 2009
Last Update Posted : March 6, 2009
Sponsor:
Information provided by:

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A New Model to Enhance Wound Healing Using Autologous Keratinocytes in Platelet Concentrates - a Prospective Randomized Trial.
Study Start Date : June 2005
Primary Completion Date : March 2006

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Complete Wound Healing [ Time Frame: Post operative day 5 and every other day thereafter ]

Secondary Outcome Measures :
  1. Pain [ Time Frame: Post operative day 5 ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: March 6, 2009    Key Record Dates
Results First Posted: March 6, 2009
Last Update Posted: March 6, 2009
Last Verified: February 2009

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Skin graft donor site healing
skin
wound
platelet concentrate
keratinocytes
burns