This Study is Testing the Use of MatriDermMATRINERVENCT07292415
Nerve Grafting Using MATRIderm® in Traumatic Digital Nerve Injuries: a Randomized, Single-center, Controlled Study
A study testing Standard peripheral nerve repair under regional anesthesia with magnification; epineural sutures placed, followed by 2-week immobilization if needed. and 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. in people with This Study is Testing the Use of MatriDerm, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- This Study is Testing the Use of MatriDerm
- What is being tested?
- Standard peripheral nerve repair under regional anesthesia with magnification; epineural sutures placed, followed by 2-week immobilization if needed. and 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.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2026to 5 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, Alpes Maritimes, 06000
Olivier CAMUZARD, Pr, 4 92 03 36 62 ext. +33, camuzard.o@chu-nice.fr
Olivier CAMUZARD, Pr
About this study
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.
Read more
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.
- Being tested
- Standard peripheral nerve repair under regional anesthesia with magnification; epineural sutures placed, followed by 2-week immobilization if needed., 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard peripheral nerve repair under regional anesthesia with magnification; epineural sutures placed, followed by 2-week immobilization if needed.Procedure or surgery
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.
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| "Nerve suture alone" group | Sham comparator | Not described Receives: 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 | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 12 months after surgery (give or take 1 month)
Secondary outcomes (5)
Incidence of neuroma formation at 12 months after digital nerve repair
The proportion of patients developing neuromas within 12 months after surgery will be compared between the experimental group (nerve suturing plus MatriDerm® wrapping) and the control group (nerve suturing alone). This measure evaluates whether MatriDerm® reduces the risk of neuroma formation after nerve repair.
Measured: 12 months after surgery (give or take 1 month)
Incidence of chronic pain at 12 months after digital nerve repair
The proportion of patients reporting chronic pain one year after surgery will be compared between the experimental group (nerve suturing plus MatriDerm® wrapping) and the control group (nerve suturing alone). This measure assesses whether MatriDerm® reduces the occurrence of long-term postoperative pain.
Measured: 12 months after surgery (give or take 1 month)
Incidence of cold intolerance at 12 months after digital nerve repair
The proportion of patients experiencing cold intolerance one year after surgery will be compared between the experimental and control groups. This measure evaluates the effect of MatriDerm® nerve wrapping on reducing postoperative sensitivity to cold.
Measured: 12 months after surgery (give or take 1 month)
Patient satisfaction with scar quality at 12 months after surgery
Patient-reported satisfaction regarding the appearance and quality of the surgical scar will be collected using a 5-point scale (very satisfied, satisfied, neutral, disappointed, dissatisfied). Results will be compared between patients in the experimental group (MatriDerm® wrapping) and the control group (suture alone).
Measured: 12 months after surgery (give or take 1 month)
Overall patient satisfaction at 12 months after surgery
Overall satisfaction with the surgical outcome will be assessed using a 5-point scale (very satisfied, satisfied, neutral, disappointed, dissatisfied). Comparison will be made between the experimental group (MatriDerm® wrapping) and the control group (suture alone) to evaluate the impact of MatriDerm® on overall patient satisfaction.
Measured: 12 months after surgery (give or take 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start5 Feb 2026
- Primary completion5 Aug 2028 (estimated)
- Study completion5 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This Study is Testing the Use of MatriDermStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 35 patients will receive standard nerve stitching alone. 35 patients will receive nerve stitching plus MatriDerm® wrapping.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292415
- Sponsor's protocol ID
- 24-PP-12
- Acronym
- MATRINERVE
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Grafting Using MATRIderm® in Traumatic Digital Nerve Injuries: a Randomized, Single-center, Controlled Study
- ClinicalTrials.gov ID
- NCT07292415
- Acronym / sponsor ID
- MATRINERVE / 24-PP-12
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 5 Aug 2028 (estimated)
- Study completion
- 5 Aug 2028 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 35 patients will receive standard nerve stitching alone. 35 patients will receive nerve stitching plus MatriDerm® wrapping.
| Arm | Type | Receives |
|---|---|---|
| "Nerve suture alone" group | Sham comparator | 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 | 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | "Nerve suture alone" group |
| 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. | Procedure or surgery | "Nerve suturing and sleeving" group |
Primary outcome
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.
Time frame: 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.
5 secondary outcomes
Incidence of neuroma formation at 12 months after digital nerve repair
Time frame: 12 months after surgery (give or take 1 month)
Incidence of chronic pain at 12 months after digital nerve repair
Time frame: 12 months after surgery (give or take 1 month)
Incidence of cold intolerance at 12 months after digital nerve repair
Time frame: 12 months after surgery (give or take 1 month)
Patient satisfaction with scar quality at 12 months after surgery
Time frame: 12 months after surgery (give or take 1 month)
Overall patient satisfaction at 12 months after surgery
Time frame: 12 months after surgery (give or take 1 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard peripheral nerve repair under regional anesthesia with magnification; epineural sutures placed, followed by 2-week immobilization if needed. and 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. in people with This Study is Testing the Use of MatriDerm, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier CAMUZARD, Pr (4 92 03 36 62 ext. +33, camuzard.o@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months after surgery (give or take 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.