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

Insel Gruppe AG, University Hospital Bern74 enrolled

Overview

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®

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Digital Nerve Injuries

Interventions

Tisseel®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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Insel Gruppe AG

Bern, Switzerland

Outcomes

Primary Outcomes

two point discrimination

For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used

Time frame: preoperative

two point discrimination

For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used

Time frame: 6 weeks postoperative

two point discrimination

For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used

Time frame: 12 weeks postoperative

two point discrimination

For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used

Time frame: 24 weeks postoperative

Secondary Outcomes

Neuroma formation

* presence of Hofmann-Tinel sign * Allodynographia/Mapping (Semmes-Weinstein Monofilament (SWMF) assessment as described by Spicher et al. (17); Sammons Preston Rolyan) performed by a trained hand therapist * detection of a neuroma in ultrasound examination (measurement of three cross-section areas: proximal, distal and at the level of the neurorrhaphy) performed by a therefore certified hand surgeon (Philips iU22 Medical system or Philips 70 affiniti)

Time frame: 6 weeks postoperative

Grip strength

using a JAMAR dynamometer

Time frame: 12 weeks postoperative

Central Contacts

Esther Voegelin, Prof. Dr.

CONTACT

+41316328014 esther.voegelin@insel.ch

Léna Dietrich, Dr. med.

CONTACT

+41316326440 lena.dietrich@insel.ch

Data from ClinicalTrials.gov

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Active range of motion

using a goniometer

Time frame: 6 weeks postoperative

Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain

with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain

Time frame: 6 weeks postoperative

quickDASH score (Disabilities of the Shoulder, Arm and Hand)

a 11 item questionnaire: filled out by the patient

Time frame: preoperative

STI-Test: (Shape-Texture Identification test)

This test is a standardized outcome measure of sensory function of the median and ulnar nerves of the hand: max. score for completed test = 6 points, min. score = 0

Time frame: 12 weeks postoperative

Neuroma formation

Time frame: 12 weeks postoperative

Neuroma formation

Time frame: 24 weeks postoperative

Neuroma formation

Time frame: 48 weeks postoperative

Grip strength

using a JAMAR dynamometer

Time frame: 24 weeks postoperative

Grip strength

using a JAMAR dynamometer

Time frame: 48 weeks postoperative

Active range of motion

using a goniometer

Time frame: 12 weeks postoperative

Active range of motion

using a goniometer

Time frame: 24 weeks postoperative

Active range of motion

using a goniometer

Time frame: 48 weeks postoperative

Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain

with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain

Time frame: 12 weeks postoperative

Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain

with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain

Time frame: 24 weeks postoperative

Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain

with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain

Time frame: 48 weeks postoperative

quickDASH score (Disabilities of the Shoulder, Arm and Hand)

a 11 item questionnaire: filled out by the patient

Time frame: 6 weeks postoperative

quickDASH score (Disabilities of the Shoulder, Arm and Hand)

a 11 item questionnaire: filled out by the patient

Time frame: 12 weeks postoperative

quickDASH score (Disabilities of the Shoulder, Arm and Hand)

a 11 item questionnaire: filled out by the patient

Time frame: 24 weeks postoperative

quickDASH score (Disabilities of the Shoulder, Arm and Hand)

a 11 item questionnaire: filled out by the patient

Time frame: 48 weeks postoperative

STI-Test: (Shape-Texture Identification test)

This test is a standardized outcome measure of sensory function of the median and ulnar nerves of the hand: max. score for completed test = 6 points, min. score = 0

Time frame: 24 weeks postoperative

STI-Test: (Shape-Texture Identification test)

This test is a standardized outcome measure of sensory function of the median and ulnar nerves of the hand: max. score for completed test = 6 points, min. score = 0

Time frame: 48 weeks postoperative