NCT05490940

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

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®

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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).

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-08-08
• Last updated: 2023-03-03

Locations

1 site across 1 country: Switzerland