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Polyethylene Glycol-Mediated Fusion Improves Surgical Outcomes Following Peripheral Nerve Injury: Two Institution Case Series
Wesley P. Thayer, MD, PhD1; Richard C. Trevino, MD2; Sara C. Chaker, Research Fellow1; Gabriella H. Cohen, Student3; Seth Schulman, MD3
1Vanderbilt University, Nashville, TN; 2WellSpan Health, York, PA; 3Neuraptive Therapeutics, Philadelphia, PA

Peripheral nerve injury (PNI) commonly results in prolonged recovery and ultimately in a permanent reduction or loss of sensation and/or function distal to the injury. Surgical repair of lower extremities repair is often done outside the window of immediate repair and undergoes Wallerian degeneration (WD). Recovery from PNI is a slow process (~ 1-2 mm/day), that only partially and non-specifically reinnervates distal tissues. Here we combine data for 6 patients from two different institutions using polyethylene glycol-mediated surgical coaptation (PEG fusion) and evaluate the effect on recovery of sensibility in damaged nerves using PEG fusion.
Methods: Data was combined from two institutions (Wellspan, York, PA and Vanderbilt, Nashville, TN) evaluating PEG fusion in adult patients with upper extremity peripheral nerve injuries. Both protocols were approved by the IRB; all participants provided written informed consent. Each patient had nerves treated with calcium free solution for 1 minute, followed by repair using standard microsurgical technique under loupe magnification by a single surgeon. Patients then had nerves treated with PEG solution (149.25 mM (50%) solution of PEG 3.3kD in sterile water). Following the repair of the nerve and the addition of the PEG solution, the nerve was treated with a calcium containing solution. Each of the patients was then seen for follow-up visits at which the outcomes were observed and recorded. Patient tactile sensation was evaluated by two-point discrimination (2PD) values and Semmes-Weinstein monofilament (SWM) score and noted as responders and non-responders.
Results: Six patients were assigned neurorrhaphy with PEG. All patients had complete transections and lacerations, all of which resulted in loss of sensory function. Participants were five males and one female, and the mean age was 36.7 years. All participants experienced some sensation return and five of the six experienced meaningful or complete clinical recovery. Furthermore, one subject who had a complete sensation return received PEG therapy to a sural nerve autograft. Diffusion tensor tractography and analysis suggest a successful PEG axonal fusion of the repaired nerve. No adverse events were identified.
Conclusions:

  • At two different institutions, PEG fusion resulted in meaningful sensory improvement in 5 out of 6 patients.
  • Patient recovery was accelerated beyond expected recovery times.
  • PEG appears to be safe and well tolerated.
  • These results inform an ongoing randomized-controlled clinical trial evaluating NTX-001 (PEG containing drug device combination) in acute peripheral nerve injuries (Clinical Trial.gov NCT04572906)

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