Patients presenting a total section of a major nerve at the arm, forearm, or leg, and treated by conventional nerve suture under microscope within ten days of the trauma. Patients with nerve autografts performed in good conditions (well-vascularized bed, absence of tension, operation performed within 4 months after the nerve section) can be included in the study.
Conditions
Interventions
Trade Name: Prograf 0.5 mg Capsules
Product Name: Prograf
Product Code: FK506
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tacrolimus
CAS Number: 104987-11-3
Current Sponsor code: FK506
Con
Sponsors
Hôpital Erasme, Cliniques Universitaires de Bruxelles
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients of any race, 18 years of age or older. 2. Patient presents total nerve section of major nerve of the arm, forearm or leg and undegoing microsurgical suture or graft by hand specialist, within 10 days of trauma (or within 4 months in case of nerve autograft). 3. No evidence of wound infection. 4. Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study. 5. Female patients in active sexual years, with contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has psychological or general neurological problems. 2. Patient has a major skin defect. 3. Patient has an avulsive mechanism of nerve injury. 4. Patient has a nerve defect obliging to suture under tension. 5. Patient has a polytraumatism. 6. Patient has a concomitant peripheral nerve affection. 7. Patient suffers from arterial hypertension. 8. Patient suffers from abnormal renal function (serum creatinin > 1.5 mg/dl). 9. Patient suffers from hyperlipidemia. 10. Patient suffers from diabetes mellitus. 11. Patient is under treatment of glucose-lowering drugs. 12. Patient needs concomitant immunosuppressive or steroid treatment. 13. Patient is pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to evaluate in humans a potential benefit related to Tacrolimus after nerve repair. This is a open, prove of concept type of study, where the speed and quality of nerve regeneration under Tacrolimus medication will be evaluated in ten patients presenting a peripheral nerve section.;Secondary Objective: None;Primary end point(s): Clinical and neurophysiological evaluation of the speed and quality of nerve regeneration under Tacrolimus medication. | — |
Countries
Belgium
Outcome results
None listed