Preliminary Outcomes from a Randomized Control Trial using Adjunct Polyethylene Glycol Therapy for Human Peripheral Nerve Repair
Gabriella E Glassman, BS1,2; Jennifer Black, PharmD3; Alonda Pollins, MLI4; Patrick Assi, M.D.1; Isaac V Manzanera Esteve, PhD4; David Colton Riley, BS5; Ravinder Bamba, MD6; Wesley P. Thayer, M.D., PhD1; Jun Yao, RN1
1Vanderbilt University Medical Center, Nashville, TN; 2Florida State University, Tallahassee, TN; 3Meharry Medical College, Nashville, TN; 4Vanderbilt University, Nashville, TN; 5Department of Plastic Surgery, Vanderbilt University Medical Center, Nashville, TN; 6Indiana University, Indianapolis, IN
Traumatic peripheral nerve injuries (PNIs) can have devastating consequences and result in a lifetime of functional disability. Polyethylene glycol (PEG) fusogen therapy presents a novel approach to optimizing neurorrhaphy outcomes in the setting of traumatic PNIs. PEG acts to prevent the axon loss that occurs during Wallerian degeneration and directly promotes fusion of axon plasma membranes. Animal models have demonstrated PEG’s superiority in nerve repair when compared to controls; however, this has yet to be studied in the setting of a human randomized control trial (RCT). This RCT aims to evaluate the preliminary findings as well as the safety profile of PEG for human nerve repairs.
After attaining institutional review board approval, PEG was randomly assigned to enrolled subjects with Sunderland Class 5 traumatic nerve transections of the distal forearm and hand. Each nerve was repaired under loop magnification by a single surgeon (WPT) within 48 hours of hospital admission at a tertiary level 1 trauma center. The participants underwent post-operative sensory assessments using two-point discrimination and Semmes Weinstein monofilament testing at designated follow up visits (1 week, 1 month, 3 months, 6 months, and 1 year). Medical Research Council Classification (MRCC) scores were used to assess meaningful sensory recovery. The scores were then grouped into the following categories: S0-S2 were assigned to group one, S3 to group two, S3+ to group three, and S4 to group four. The Michigan Hand Questionnaire (MHQ) was used to evaluate patient quality of life.
Four participants were enrolled after suffering from either digital, median and ulnar nerve transections. All four participants were randomly assigned PEG. The mean age was 36.3 ±15 years and all participants were males. The MRCC average for 1 week, 1 month, and last follow up visit were 1 ± 0, 1.5 ± 1, and 2.5 ± 1.3, respectively. Additionally, one subject received an autograft with PEG solution. The average MHQ score returned nearly to baseline level by one year. No adverse events were reported in association with PEG repair.
Three out of the 4 subjects who received PEG after neurorrhaphy had improved sensory assessments at their last follow-up visit. Our preliminary findings suggest that PEG is safe and may allow for improved nerve repairs and sensation recovery. Further studies are needed with larger population number to identify the optimal dosing of PEG solution as well as appropriate timing of administration.
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