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

Обзор

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.

Вмешательства

• Процедура 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 standard
• Процедура 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

Первичные конечные точки

• Percentage of patients achieving ≤6 mm in 2-point static discrimination test at fingertip pulp 12 months after traumatic digital nerve repair, comparing MatriDerm® nerve wrapping versus standard nerve suturing. [Срок оценки: 12 months after surgery (give or take 1 month)]

Вторичные конечные точки (5)

• Incidence of neuroma formation at 12 months after digital nerve repair [Срок оценки: 12 months after surgery (give or take 1 month)]
• Incidence of chronic pain at 12 months after digital nerve repair [Срок оценки: 12 months after surgery (give or take 1 month)]
• Incidence of cold intolerance at 12 months after digital nerve repair [Срок оценки: 12 months after surgery (give or take 1 month)]
• Patient satisfaction with scar quality at 12 months after surgery [Срок оценки: 12 months after surgery (give or take 1 month)]
• Overall patient satisfaction at 12 months after surgery [Срок оценки: 12 months after surgery (give or take 1 month)]

Критерии участия

Критерии включения

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

Критерии исключения

• Pre-existing sensory disorders
• History of nerve damage in the affected hand
• Known hypersensitivity to bovine proteins
• Active infection in the affected hand
• 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
• Pregnant or breastfeeding women of childbearing age

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU de Nice — Nice

Идентификаторы

NCT: NCT07292415 · 24-PP-12

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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