- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267663
Vein Wrapping in Peripheral Nerve Injury Repair Below The Elbow
Vein Wrapping in Peripheral Nerve Injury Repair Below The Elbow .
Peripheral nerve injuries are common after trauma and may cause pain, sensory loss, motor deficit, and long-term disability. Scar formation and perineural adhesion at the repair site interfere with axonal regeneration, impair gliding of the nerve within surrounding tissues, and are main contributors to painful neuroma formation and persistent functional deficits.
After peripheral nerve injury or incomplete regeneration, disorganized axonal sprouting and connective tissue proliferation at the proximal nerve end can result in a traumatic neuroma. This structure is characterized by tangled axons, Schwann cells, and fibrous tissue, leading to pain, hypersensitivity, and impaired function. Neuromas often develop when regenerating axons cannot reconnect with their distal targets, typically due to excessive scar formation or tension at the repair site.Scar tissue not only obstructs regenerating axons but also mechanically tethers the nerve, resulting in traction neuritis and painful hypersensitivity.
Autologous vein wrapping in which a segment of the patient's own vein is placed around the repaired nerve has been shown to reduce perineural scarring and neuroma formation by acting as both a mechanical barrier and a biological conduit. The vein sheath isolates the nerve from surrounding fibrotic tissue, while its inner endothelial surface supports axonal guidance and nutrient diffusion. Experimental studies have demonstrated improved axonal regeneration, reduced collagen deposition, and better functional recovery when vein wrapping is used compared to simple neurorrhaphy.
Clinical studies have also reported favorable outcomes with vein wrapping, particularly in preventing recurrent or painful neurom. It is a simple, cost-effective, and autologous technique that avoids immune reaction or foreign body response. Patients treated with vein wrapping often show reduced neuropathic pain and improved sensory recovery.
Clinically, Tinel's sign (Hoffmann-Tinel test) is widely used as a simple bedside test to detect regenerating axons advancing along a nerve or to localize symptomatic neuromas. A progressive distal-to-proximal Tinel's sign often indicates advancing regeneration, whereas a static or painful Tinel's sign at the repair or nerve ends may indicate neuroma-in-continuity or symptomatic end neuroma. Because it is easy to perform and commonly recorded in clinical follow-up, Tinel's sign is an appropriate secondary outcome to assess the presence of symptomatic neuroma or nerve regeneration after vein-wrapped repairs.
Therefore, this study aims to systematically evaluate the effect of autologous vein wrapping on neuroma formation, functional recovery, and associated clinical signs, such as Tinel's sign, in patients with traumatic peripheral nerve injuries.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18-60 years with traumatic peripheral nerve injury requiring surgical repair.
- Nerve injury distal to the elbow.
- Time from injury to surgical repair less than 6 months .
Exclusion Criteria:
- Injury proximal to the elbow.
- Children below 18.
- History of multiple comorbidities (e.g., diabetes+another chronic illness)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: study group
patients will undergo standard epineural nerve repair with autologous vein wrapping, and outcomes will be assessed at follow-up intervals.
|
The nerve ends are repaired using a standard epineural microsuture technique (usually 8-0 or 9-0 nylon). Tension-free coaptation is ensured.
The vein is wrapped loosely around the nerve repair site without any tension.
The edges are sutured with a few fine 8-0 or 9-0 nylon stitches.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of neuroma formation
Time Frame: 12 months postoperatively
|
assessed by high-resolution ultrasonography
|
12 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction and functional scores (DASH).
Time Frame: 12 months
|
Patient satisfaction and functional scores (DASH).
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Vein Wrap in peripheral Nerve
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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