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

• Status: Not yet recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of sensitivity after primary surgical treatment of digital nerve injuries with microsurgical epineural end-to-end neurorrhaphy alone or in combination with the fibrin glue Tisseel®

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: Baxter Healthcare Corporation
• Treatments: Fibrin Tissue Adhesive

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