Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

February 5, 2009 updated by: Centre Hospitalier Universitaire Vaudois

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: Standard dressings
Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.
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.
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.
Other: Standard dressings
Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Wound Healing
Time Frame: Post operative day 5 and every other day thereafter
Time required for complete epithelialization in days
Post operative day 5 and every other day thereafter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Post operative day 5
Pain evaluated on a Visual Analog Scale (VAS) from 0 (no pain) to 10 (extreme pain), specifically during dressing replacement.
Post operative day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

January 2, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

March 6, 2009

Last Update Submitted That Met QC Criteria

February 5, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 132/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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