Sensory Recovery of Digital Nerves After Microsurgical Epineural Neurorrhaphy Alone or in Combination With Tisseel - RET

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Aug 4, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how well people recover feeling in their fingers after surgery for digital nerve injuries. The study will compare two methods: one that uses a standard surgical technique called microsurgical epineural neurorrhaphy and another that combines this technique with a special glue called Tisseel®. The goal is to see if using the glue helps improve sensitivity in the fingers after surgery.

To participate in this trial, you need to be at least 18 years old and have a specific type of nerve injury in one or more fingers that can be treated with direct surgical stitches. You will not be eligible if you have certain conditions that could affect your nerve healing, like diabetes or previous surgeries on the injured finger. If you join the study, you will receive the surgery and then be followed up to assess how well your feeling returns in the affected fingers. It’s important to know that the trial is not yet recruiting participants, so you will need to wait until it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written consent to participate in the study
• • Acute digital nerve lesion(s) distal to the superficial arterial arch on one or more fingers that qualify for primary direct end-to-end microsurgical epineural neurorrhaphy
• • Age ≥18 years
• Exclusion Criteria:
• • Lesions that do not allow a tension-free direct suture, partial transections, amputation, re-vascularisation
• • Age \< 18 years
• • Pre-operation on the injured finger
• • Clinical comparison with contralateral finger not possible (e.g. due to amputation).
• • Treatment that is known to inhibit the growth/regeneration of nerves impaired or can cause neuropathy - such as chemo- or radiotherapy before or during the whole study
• • Systemic and local neurological impairments (polyneuropathy, diabetes mellitus, carpal tunnel syndrome, etc.)
• • History of vascular diseases like Raynaud's disease syndrome that affects blood flow or sensation in the upper can affect the extremities
• • Known or suspected non-compliance
• • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia
• • Women who are pregnant (urin pregnancy test) or breast feeding. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
• • Previous enrolment into the current study
• • Enrolment of the investigator, his/her family members, employees and other dependent persons
• • Contraindications to the investigational product, e.g. known allergy to components of the Tisseel® fibrin glue
• • Participation in another interventional study within the 30 days preceding and during the present study