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

Centre Hospitalier Universitaire de Nice

Status: Not yet enrolling

Conditions: This Study is Testing the Use of MatriDerm

Treatments: 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.; Procedure: Standard peripheral nerve repair under regional anesthesia with magnification; epineural sutures placed, followed by 2-week immobilization if needed.

Study type: Interventional

Funder types: Other

Identifiers

NCT07292415

24-PP-12

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient aged 16 to 75
2. Patient with a palm or finger wound with sensory nerve damage (partial >50% or total)
3. Indication for repair by direct suture in the operating room
4. Possibility of attending a follow-up visit after 1 year
5. Patient affiliated with a social security system
6. Patient who has given their written consent after receiving written and oral information

Exclusion criteria

1. Pre-existing sensory disorders
2. History of nerve damage in the affected hand
3. Known hypersensitivity to bovine proteins
4. Active infection in the affected hand
5. Patient protected by law under guardianship or curatorship, or unable to participate in a clinical study MATRINERVE 24-PP-12 Version No. 1.0 dated July 22, 2025 Page 8 of 40 clinical trial under Article L. 1121-16 of the French Public Health Code
6. Pregnant or breastfeeding women of childbearing age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

"Nerve suture alone" group

Sham Comparator group

Treatment:

Procedure: Standard peripheral nerve repair under regional anesthesia with magnification; epineural sutures placed, followed by 2-week immobilization if needed.

"Nerve suturing and sleeving" group

Experimental group

Treatment:

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.