Dupuytren's Contracture Clinical Trial
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
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 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01674634 -
Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures
|
Phase 3 | |
| Completed |
NCT01715467 -
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment
|
N/A | |
| Completed |
NCT01407068 -
Administration of Two Injections for Multiple Dupuytren's Contractures
|
Phase 3 | |
| Completed |
NCT00528931 -
A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture
|
Phase 1 | |
| Completed |
NCT00565019 -
Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture
|
Phase 3 | |
| Completed |
NCT01588353 -
Collagenase Option for Reduction of Dupuytren's Contracture in Japan
|
Phase 3 | |
| Completed |
NCT00468949 -
Health-Related Quality of Life in Patients With Dupuytren's Disease
|
Phase 1 | |
| Completed |
NCT01444729 -
Post Approval Commitment Study
|
N/A | |
| Terminated |
NCT05877066 -
Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
|
||
| Completed |
NCT01265420 -
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
|
Phase 4 | |
| Completed |
NCT01229436 -
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
|
Phase 3 | |
| Completed |
NCT00528606 -
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
|
Phase 3 | |
| Completed |
NCT00004409 -
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
|
Phase 2 | |
| Completed |
NCT00014742 -
Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease
|
Phase 3 |