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

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Marseille
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00931567
First received: June 30, 2009
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Dupuytren's Contracture
Biological: Autologous platelets gel
Device: Vaselitulle
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Time duration between the operation and the complete wound healing. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • -The pain during the dressings' change using a visual scale going from 0 to 10. -The bleeding of the wound. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: August 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00931567

Locations
France
CHU Hôpital de la Timone
Marseille, Cedex 05, France, 13385
Centre Hospitalier Universitaire de Nice Hôpital de Cimiez
Nice, France, 06000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
University Hospital, Marseille
  More Information

No publications provided by Centre Hospitalier Universitaire de Nice

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00931567     History of Changes
Other Study ID Numbers: 01-APR-07
Study First Received: June 30, 2009
Last Updated: March 19, 2012
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority
France: Institutional Ethical Committee

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 28, 2014