Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing

March 19, 2012 updated by: Centre Hospitalier Universitaire de Nice

This study is a clinical, multicentric, randomised open trial. The objective is to evaluate the efficiency, in terms of wound healing speed, of peroperative application of autologous platelets gel versus standardized wound dressing. The wound Healing model used in this study is the " open palm " surgical treatment of Dupuytren's disease.

Dupuytren's disease is a fibroproliferative disease of the palmar and digital fascia of the hand that may lead to a fixed flexion contracture of the fingers.

The main indication for surgery is the loss of finger extension. In some cases of palmar Dupuytren's disease the surgical removal of diseased tissues may lead to a cutaneous loss of substance (" open palm technique "). This loss of substance is treated using vaseline dressing and the wound healing is obtained in 4 weeks.

Autologous platelets gel (Platelet Rich Fibrin) is obtained from the patient's own blood. Some recent studies have shown that it speeds up the wound healing and enhances the quality of the scar.

PRF belongs to a new generation of autologous platelet gel that are easily obtained after centrifugation of patient's own blood.

The Platelet Rich Fibrin (PRF) contains many wound healing factors : Three pro inflammatory cytokines ( IL1,IL6, TNF-alpha) , one anti-inflammatory cytokine (IL4) and a growth factor (VEGF).

The study will be running on 60 days, starting from the operation day. The wound healing evaluation will be achieved at day1, day2, day7, day14, day 21 day 28 and day 60.

The inclusion criteria are : age over 18, Dupuytren's disease with an indication of surgical treatment using the open palm technique, patients having signed the agreement form.

80 patients will be included in the study and divided into 2 groups . The first group of patients will receive PRF and the other group will receive vaseline dressings.

The speed and the quality of wound healing will be compared.We will also compare the number of patients with a complete wound healing at day 21 . Moreover,we will evaluate the pain during the dressings' change and the bleeding of the palmar wound.

For the wound healing speed , a difference of 7 days between the two groups will be considered as statistically significant.

Statistical analysis will be achieved using Chi2 test and Logrank test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Main evaluation criteria :

Time duration between the operation and the complete wound healing. The wound healing is considered complete when the skin is closed and when the patient do not need to have dressings. A picture of the wound at the end of the wound healing process is taken for each patient.

Secondary criteria of evaluation :

At day 1, day7, day 14, day 21 and day 28 two data will be collected :

  • The pain during the dressings' change using a visual scale going from 0 (no pain) to 10 (very painful).
  • The bleeding (and "exudate") of the wound which can be absent, low, moderate or abundant.

The investigators will collect all the side effects described by the patients for each wound healing technique.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

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

  • France
      • Nice, France, 06000
        • Centre Hospitalier Universitaire de Nice Hôpital de Cimiez
    • Cedex 05
      • Marseille, Cedex 05, France, 13385
        • CHU Hôpital de la Timone

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18
  • Patient with Dupuytren's disease with an indication of surgical treatment using the open palm technique.
  • Agreement form signed
  • patient affiliated to the national health system.

Exclusion Criteria:

  • Patients allergic to one of the components of the dressings used in this study.
  • Patients with insulin-requiring diabetes
  • Patients sustaining anti-cancer treatment.
  • Pregnant women.
  • Patients included in another study.
  • Patients who cannot come to the follow up visits.

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
Active Comparator: Vaselitulle
after surgery, the loss of substance is treated using vaseline dressing
Device: Vaselitulle
application of standardized wound dressing after the " open palm " surgical treatment of Dupuytren's disease.
Experimental: Autologous platelets gel
after surgery, the loss of substance is treated with Autologous platelets gel
Biological: Autologous platelets gel
Application of autologous platelets gel (Platelet Rich Fibrin) after the " open palm " surgical treatment of Dupuytren's disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time duration between the operation and the complete wound healing.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
-The pain during the dressings' change using a visual scale going from 0 to 10. -The bleeding of the wound.
Time Frame: 18 months
18 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nice

Collaborators

University Hospital, Marseille

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

August 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

July 1, 2009

First Posted (Estimate)

July 2, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-APR-07

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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