Vein Wrapping in Peripheral Nerve Injury Repair Below The Elbow

November 25, 2025 updated by: Alaa Mohamed Abd Elmoniem Mohamed, Assiut University

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

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

43

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

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

No

Studies a U.S. FDA-regulated device product

No

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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