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

Insel Gruppe AG, University Hospital Bern

Status: Not yet enrolling

Conditions: Digital Nerve Injuries

Treatments: Drug: Tisseel®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05490940

2021-02050

Details and patient eligibility

About

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®

Full description

Lacerations of the fingers with nerve injuries are a common reason for a presentation at the surgical emergency ward of the Inselspital Bern. The patient complains of either reduced sensitivity or even complete numbness in the affected finger. This leads to a clear functional loss in daily activities and should be reliably tested during the clinical examination. If a nerve lesion is suspected, the wound and the affected nerve should be explored in the operating room. If the suspicion is confirmed, the sheath of the two nerve endings can be sewn under the microscope or with surgical loupes.

Tension free microsurgical epineural end-to-end neurorrhaphy of digital nerves after sharp or blunt lesions is a simple and effective procedure in order to regain sensory recovery and prevent neuroma formation.

Industry is promoting different aids in order to achieve better outcomes after repair - such as tissue glue, grafts and conduits. These products are more or less expensive, which becomes more and more important as the general cost in the Swiss health system are progressively increasing.

The aim of this randomized, prospective controlled study is thus to compare the clinical benefit of a primary epineural end-to-end neurorrhaphy combined with fibrin glue (Tisseel®) versus a simple epineural end-to-end neurorrhaphy alone.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Microsurgical end-to-end neurorrhaphy alone

No Intervention group

Description:

This group of patients receives a simple, tension-free, end-to-end microsurgical neurorrhaphy alone (without fibrin glue)

Microsurgical end-to-end neurorrhaphy in combination with an enwrapping with fibrin sealant Tisseel®

Experimental group

Description:

This group of patients receives a simple, tension-free, end-to-end microsurgical neurorrhaphy in combination with an enwrapping with fibrin sealant Tisseel®.

Treatment:

Drug: Tisseel®