Nerve Grafting Using MATRIderm® in Traumatic Digital Nerve Injuries: a Randomized, Single-center, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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. By participating, patients will help improve treatments for hand injuries and support research on nerve healing.
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 12 months after surgery (give or take 1 month)
The primary outcome is the recovery of tactile discrimination in the fingertip pulp 12 months after surgery. It is assessed using the static 2-point discrimination test. The proportion of patients achieving a discrimination distance of ≤6 mm will be compared between the experimental group (nerve suturing plus MatriDerm® wrapping) and the control group (nerve suturing alone). This measure reflects the functional sensory recovery of the repaired nerve and allows evaluation of the potential benefit of MatriDerm® as an adjunct to standard nerve repair.
次要结局
- Incidence of neuroma formation at 12 months after digital nerve repair(12 months after surgery (give or take 1 month))
- Incidence of chronic pain at 12 months after digital nerve repair(12 months after surgery (give or take 1 month))
- Incidence of cold intolerance at 12 months after digital nerve repair(12 months after surgery (give or take 1 month))
- Patient satisfaction with scar quality at 12 months after surgery(12 months after surgery (give or take 1 month))
- Overall patient satisfaction at 12 months after surgery(12 months after surgery (give or take 1 month))