Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
Vanderbilt University Medical Center
Summary
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.
Description
Our own preclinical animal studies have been designed to take advantage of PEG. We have used the fusogenic properties of PEG and this has allowed us to demonstrate a rapid and decisive electrophysiological recovery of either crushed or completely severed sciatic nerves in a commonly accepted mammalian model for peripheral nerve injury (Bittner et al JSR 2012). Recently, we modified previously published mammalian techniques. Our goal was to eliminate laboratory solutions that have not been approved for use in humans and replace them with readily available reagents commonly used in clinical app…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 ort…
Interventions
- DrugPolyethylene 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.
Location
- Vanderbilt University Medical CenterNashville, Tennessee