A Phase 2/3 interventional study of Autologous platelets gel and Vaselitulle in Dupuytren's Contracture, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-20.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 2/3, Interventional, and Treatment
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.
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.
76 studies on the registry are indexed under Dupuytren Contracture; 16 are open to participants now.
This study's enrollment of 80 is above the median of 72 across 55 interventional studies indexed under Dupuytren Contracture.
Browse Dupuytren Contracture studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
after surgery, the loss of substance is treated using vaseline dressing
Device: Vaselitulle
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.
application of standardized wound dressing after the " open palm " surgical treatment of Dupuytren's disease.
Time duration between the operation and the complete wound healing.
Time frame: 18 months
-The pain during the dressings' change using a visual scale going from 0 to 10. -The bleeding of the wound.
Time frame: 18 months
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice