Clinical trial

Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function

Name

191655

Description

Current strategies for peripheral nerve repair are severely limited. Even with current techniques, it can take months for regenerating axons to reach denervated target tissues when injuries are proximally located. This inability to rapidly restore the loss of function after axonal injury continues to produce poor clinical outcomes. The investigators propose testing the efficacy and safety of a combination therapy: polyethylene glycol (PEG) assisted axonal fusion technique to repair peripheral nerve injuries in humans.

Trial arms

Trial start

2015-09-01

Estimated PCD

2025-07-01

Trial end

2026-07-01

Status

Recruiting

Phase

Early phase I

Treatment

Polyethylene glycol (PEG)

For the control groups, epineural repair or interposition grafting will be undertaken in the standard end-to-end fashion using interrupted nylon suture after irrigation of the wound with normal saline as deemed necessary by the operating surgeon. For the experimental group, the nerve(s) will be repaired using standard suture neurorrhaphy techniques and a 149.25 mM (50%) solution of PEG 3.35 kD in sterile water will then be irrigated onto the neurorrhaphy site for one minute. Following this, the approximated nerve ends will be irrigated with sterile water gently for 2 minutes. All wounds will be closed in the fashion deemed appropriate by the operating surgeon.

Arms:

epineural repair <24 hours using PEG, epineural repair >24 but <72 hours using PEG, epineural repair with autografting within 48 hours, using PEG

Other names:

PEG

Size

Primary endpoint

return of nerve function as measured by (Medical Research Council Classificatoin (MRCC)

12 months

Eligibility criteria

Inclusion Criteria: * Diagnosis of a Sunderland Class 5 traumatic neuropathy (transection injury) of a digital nerve in the upper extremity * candidates for immediate operative repair (Arm 1); * injury proceeding repair no longer than 72 hours; and * repair within 48 hours of injury that require nerve grafting; * N0 significant medical comorbidities precluding immediate repair; * willing to comply with all aspects of the treatment and evaluation schedule over a 12 months period. We plan to include subjects who have peripheral nerve injuries that are complicated by significant vascular or orthopedic damage. Exclusion Criteria: * Patients will be excluded from enrollment if their injuries exhibit gross contamination, in circumstances where soft tissue coverage is inadequate, or when staged repair is planned. * We will also exclude patients that are diabetic, have been diagnosed with a neuromuscular disease, or are undergoing chemotherapy, radiation therapy, or other treatments known to affect the growth of the neural and vascular system. * We will exclude all patients currently enrolled in another investigational study or those who are unlikely to complete the normal regime of occupational therapy. Individuals will be excluded from participation if their time of injury falls outside study parameters.

Protocol

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Updated at

2023-12-13

1 organization

1 product

1 indication

Organization

Vanderbilt University

Product

Polyethylene glycol

Indication

Peripheral Nerve Injury