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

NCT05490940 | Unknown

• 1 other identifier: 2021-02050
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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®

Conditions

Digital Nerve Injuries

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  24 weeks postoperative

Secondary Outcomes (23)

• Neuroma formation

  6 weeks postoperative

• Grip strength

  12 weeks postoperative

• Active range of motion

  6 weeks postoperative

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

  6 weeks postoperative

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

  preoperative

Study Arms (2)

Microsurgical end-to-end neurorrhaphy alone

NO INTERVENTION

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

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

Drug: Tisseel®

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).

Also known as: Neurorraphy alone

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Insel Gruppe AG

Bern, 3010, Switzerland

Location

MeSH Terms

Interventions

Fibrin Tissue Adhesive

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Esther Vögelin, Prof. Dr.

  Insel Gruppe AG, University of Bern

  STUDY CHAIR

Central Study Contacts

Esther Voegelin, Prof. Dr.

CONTACT

+41316328014; esther.voegelin@insel.ch

Léna Dietrich, Dr. med.

CONTACT

+41316326440; lena.dietrich@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study is examiner- and patient blinded. While the operating surgeon is not blinded, postoperative examinations will be performed by physicians who do not know the group assignment of the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomised, investigator-blinded, monocentric study

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: August 8, 2022
• Study Start: March 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)