Clinical trial NCT05490940: Sensory Recovery of Digital Nerves After Microsurgical Epineural Neurorrhaphy Alone or in Combination With Tisseel - RET
Official title: A Prospective Randomized Study to Evaluate Sensory Recovery of Digital Nerves After Primary Repair Performed by Microsurgical Epineural End-to-end Neurorrhaphy Alone, or in Combination With an Enwrapping With Fibrin Sealant Tisseel®
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Digital Nerve Injuries
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2022-08-08
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomised, investigator-blinded, monocentric study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: two point discrimination
timeFrame: preoperative
measure: two point discrimination
timeFrame: 6 weeks postoperative
measure: two point discrimination
timeFrame: 12 weeks postoperative
measure: two point discrimination
timeFrame: 24 weeks postoperative
Secondary outcomes:
measure: Neuroma formation
timeFrame: 6 weeks postoperative
measure: Grip strength
timeFrame: 12 weeks postoperative
measure: Active range of motion
timeFrame: 6 weeks postoperative
measure: Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
timeFrame: 6 weeks postoperative
measure: quickDASH score (Disabilities of the Shoulder, Arm and Hand)
timeFrame: preoperative
measure: STI-Test: (Shape-Texture Identification test)
timeFrame: 12 weeks postoperative
measure: Neuroma formation
timeFrame: 12 weeks postoperative
measure: Neuroma formation
timeFrame: 24 weeks postoperative
measure: Neuroma formation
timeFrame: 48 weeks postoperative
measure: Grip strength
timeFrame: 24 weeks postoperative
measure: Grip strength
timeFrame: 48 weeks postoperative
measure: Active range of motion
timeFrame: 12 weeks postoperative
measure: Active range of motion
timeFrame: 24 weeks postoperative
measure: Active range of motion
timeFrame: 48 weeks postoperative
measure: Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
timeFrame: 12 weeks postoperative
measure: Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
timeFrame: 24 weeks postoperative
measure: Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
timeFrame: 48 weeks postoperative
measure: quickDASH score (Disabilities of the Shoulder, Arm and Hand)
timeFrame: 6 weeks postoperative
measure: quickDASH score (Disabilities of the Shoulder, Arm and Hand)
timeFrame: 12 weeks postoperative
measure: quickDASH score (Disabilities of the Shoulder, Arm and Hand)
timeFrame: 24 weeks postoperative
measure: quickDASH score (Disabilities of the Shoulder, Arm and Hand)
timeFrame: 48 weeks postoperative
measure: STI-Test: (Shape-Texture Identification test)
timeFrame: 24 weeks postoperative
measure: STI-Test: (Shape-Texture Identification test)
timeFrame: 48 weeks postoperative
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Insel Gruppe AG
Study officials:
affiliation: Insel Gruppe AG, University of Bern
name: Esther Vögelin, Prof. Dr.
role: STUDY_CHAIR
References: