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

NCT ID: NCT05490940

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-12-31

Brief 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®

Detailed 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.

Conditions

Digital Nerve Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Microsurgical end-to-end neurorrhaphy alone

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

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

Group Type: EXPERIMENTAL

Tisseel®

Intervention Type: DRUG

The investigational medical product (IMP) in this study is Tisseel®, which is a tissue sealer consisting of two components:

1. Sealer protein: Human fibrinogen as "glue" component and synthetic Aprotinin, which delays fibrinolysis.

2. Human thrombin: Thrombin is an unique molecule that functions both as a procoagulant and anticoagulant. It activates platelets through its receptor on the platelets and regulates its own. generation by activating coagulation factors V, VIII and even XI resulting in a burst of thrombin formation.

Its indications are a better hemostasis, enforcement of vessel/gastrointestinal sutures and tissue sutures (mesh grafts, flaps etc).

Interventions

Tisseel®

The investigational medical product (IMP) in this study is Tisseel®, which is a tissue sealer consisting of two components:

1. Sealer protein: Human fibrinogen as "glue" component and synthetic Aprotinin, which delays fibrinolysis.

2. Human thrombin: Thrombin is an unique molecule that functions both as a procoagulant and anticoagulant. It activates platelets through its receptor on the platelets and regulates its own. generation by activating coagulation factors V, VIII and even XI resulting in a burst of thrombin formation.

Its indications are a better hemostasis, enforcement of vessel/gastrointestinal sutures and tissue sutures (mesh grafts, flaps etc).

Intervention Type: DRUG

Other Intervention Names

Neurorraphy alone

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Vögelin, Prof. Dr.

Role: STUDY_CHAIR

Insel Gruppe AG, University of Bern

Locations

Insel Gruppe AG

Bern, , Switzerland

Countries

Switzerland

Central Contacts

Esther Voegelin, Prof. Dr.

Role: CONTACT

esther.voegelin@insel.ch

+41316328014 ext. +41794401987

Léna Dietrich, Dr. med.

Role: CONTACT

lena.dietrich@insel.ch

+41316326440 ext. +41799463620

Facility Contacts

Esther Voegelin, Prof.

Role: primary

esther.voegelin@insel.ch

+41 31 6323534

Léna Dietrich, Dr.

Role: backup

lena.dietrich@insel.ch

+41 31 632 6440

Other Identifiers

2021-02050

Identifier Type: -

Identifier Source: org_study_id