NCT07292415

Nerve Grafting Using MATRIderm® in Traumatic Digital Nerve Injuries: a Randomized, Single-center, Controlled Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Hand and wrist injuries are very common, with nearly 2 million cases each year in France. Many injuries involve cuts that damage important structures such as nerves, tendons, blood vessels, bones, or joints. About 12.5% of hand wounds affect nerves, which can cause numbness, pain, or abnormal nerve growths called neuromas. Patients may also experience unusual sensations or intolerance to cold. The usual treatment for a cut nerve is to carefully stitch it back together. Sometimes, additional techniques can be used to help the nerve heal better and reduce scarring. One technique, called nerve wrapping, involves surrounding the damaged nerve with a small protective tube to support its repair. This study is testing the use of MatriDerm®, a collagen-elastin matrix originally used to help skin heal. MatriDerm® acts like a scaffold, supporting tissue repair and controlling scar formation. Its properties may also help nerves heal when placed around a stitched nerve. This is an academic, monocentric, prospective, randomized, controlled study conducted in a double-blind manner (neither the patient nor the evaluator knows which treatment is given). The goal is to see if wrapping a stitched nerve with MatriDerm® improves finger sensation recovery compared with stitching alone. Seventy patients with traumatic nerve injuries of the fingers will be included: one group of patients will receive standard nerve stitching alone and another group will receive nerve stitching plus MatriDerm® wrapping. Researchers will evaluate finger sensation one year after surgery using standard touch tests. The hypothesis is that nerve wrapping with MatriDerm® will lead to better sensory recovery than stitching alone.

Conditions

• This Study is Testing the Use of MatriDerm

Interventions

Type	Name	Description
PROCEDURE	Standard peripheral nerve repair under regional anesthesia with magnification; epineural sutures placed, followed by 2-week immobilization if needed.	Peripheral nerve repair will be performed in the operating room under axillary regional anesthesia, with a pneumatic tourniquet at 250 mmHg. The nerve will be exposed using a surgical microscope or magnifying loupes. The two nerve stumps will be carefully dissected, and epineural sutures will be placed using simple 9/10 stitches. When tension is present on the repair, postoperative immobilization will be applied for 2 weeks to protect the suture. Postoperative care and follow-up will be standardized, including regular assessments of sensory recovery and hand function.
PROCEDURE	Peripheral nerve repair under regional anesthesia with epineural sutures; nerve wrapped along its length with 1 mm MatriDerm® collagen-elastin matrix before standard skin closure.	Peripheral nerve repair will be performed in the operating room under axillary regional anesthesia with a pneumatic tourniquet at 250 mmHg. The nerve will be exposed using a surgical microscope or magnifying loupes. The two nerve stumps will be carefully dissected, and epineural sutures will be placed using simple 9/10 stitches, as in standard care. In addition, for patients in the MatriDerm® arm, the sutured nerve will be wrapped along the entire dissected length with a 1 mm MatriDerm® collagen-elastin matrix. The nerve and matrix will then be irrigated with saline before standard skin closure. Postoperative immobilization will be applied for 2 weeks if tension is present on the repair.

Timeline

• Start date: 2026-02-05
• Primary completion: 2028-08-05
• Completion: 2028-08-05
• First posted: 2025-12-18
• Last updated: 2026-04-03

Locations

1 site across 1 country: France