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
| Tracking Information | |
|---|---|
| First Received Date ICMJE | June 30, 2009 |
| Last Updated Date | March 19, 2012 |
| Start Date ICMJE | August 2007 |
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Time duration between the operation and the complete wound healing. [ Time Frame: 18 months ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00931567 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
-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 ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | 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 |
| Official Title ICMJE | 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 |
| 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. |
| 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 investigators will collect all the side effects described by the patients for each wound healing technique. |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 2 Phase 3 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Dupuytren's Contracture |
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 80 |
| Completion Date | February 2010 |
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | France |
| Administrative Information | |
| NCT Number ICMJE | NCT00931567 |
| Other Study ID Numbers ICMJE | 01-APR-07 |
| Has Data Monitoring Committee | No |
| Responsible Party | Centre Hospitalier Universitaire de Nice |
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice |
| Collaborators ICMJE | University Hospital, Marseille |
| Investigators ICMJE | Not Provided |
| Information Provided By | Centre Hospitalier Universitaire de Nice |
| Verification Date | March 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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