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
1 other identifier
interventional
80
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 30, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMarch 20, 2012
March 1, 2012
2.5 years
June 30, 2009
March 19, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Time duration between the operation and the complete wound healing.
18 months
Secondary Outcomes (1)
-The pain during the dressings' change using a visual scale going from 0 to 10. -The bleeding of the wound.
18 months
Study Arms (2)
Vaselitulle
ACTIVE COMPARATORafter surgery, the loss of substance is treated using vaseline dressing
Autologous platelets gel
EXPERIMENTALafter surgery, the loss of substance is treated with Autologous platelets gel
Interventions
Application of autologous platelets gel (Platelet Rich Fibrin) after the " open palm " surgical treatment of Dupuytren's disease.
application of standardized wound dressing after the " open palm " surgical treatment of Dupuytren's disease.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU Hôpital de la Timone
Marseille, Cedex 05, 13385, France
Centre Hospitalier Universitaire de Nice Hôpital de Cimiez
Nice, 06000, France
Related Publications (1)
Chignon-Sicard B, Georgiou CA, Fontas E, David S, Dumas P, Ihrai T, Lebreton E. Efficacy of leukocyte- and platelet-rich fibrin in wound healing: a randomized controlled clinical trial. Plast Reconstr Surg. 2012 Dec;130(6):819e-829e. doi: 10.1097/PRS.0b013e31826d1711.
PMID: 23190833DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2009
First Posted
July 2, 2009
Study Start
August 1, 2007
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
March 20, 2012
Record last verified: 2012-03