Polyethylene Glycol (PEG)-Mediated Fusion (PEG Fusion) Repair of Mixed Motor-Sensory Acute Peripheral Nerve Injuries (PNI) for Rapid and Immediate Improvement in Outcome
Abstract
The overall objective of this study is to determine the safety of PEG fusion when used with primary repair or reconstruction in patients with an acute upper extremity peripheral nerve injury. PEG is safe and effective for extending the half-life of circulating pharmaceutical products, when used in conjunction with a topical hemostatic agent in surgical wounds, and when used as a colon cleanser for endoscopic surgical procedures.However, PEG fusion has not been rigorously tested as a safe reagent to promote nerve regeneration in humans. Therefore, the goal of this Phase 2a clinical trial is to establish safety data and to examine the effect of PEG fusion on clinical outcomes including recovery of sensory and motor function. The study will enroll 40 patients receiving autograft reconstruction within 24 hours of injury. Patients within each group will be randomized to either PEG mediated reconstruction (n=120); or conventional nerve reconstruction (n=20). Patients will be enrolled across 7participating centers and followed for 2 years. Results will be externally validated using data collected in the DoD funded prospective NERVE study and will provide preliminary evidence to power a larger phase II efficacy trial.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2022
- Accession Number
- AD1193684
Entities
People
- Jaimie Shores
Organizations
- Johns Hopkins University