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 (PNI) and to examine the effect of PEG fusion on clinical outcomes including recovery of sensory and motor function. Results will be externally validated using data collected in the DoD funded prospective NERVE study (W81XWH-15-2-0074) and will provide preliminary evidence to power a larger phase II efficacy trial. Primary Endpoint: Safety will be evaluated by routinely assessing all complications at each study visit and during readmission to the hospital. Complications or problems occurring within the first 30 days including surgical site infections, wound dehiscence/breakdown, exposure of nerves and/or their repairs and reconstructions, breakdown of nerve repair or reconstruction, seroma/hematoma requiring an additional procedure to treat, and any other local wound complications related to the zone of nerve injury that require an additional surgical procedure will be documented prospectively from the medical records and verified by the treating surgeon at each study visit. Long term complications include the absence or failure of apparent nerve regeneration by clinical determination of graded sensory and motor assessments, clinically significant neuroma, chronic pain, need for secondary reconstructive procedures attributable to poor nerve regeneration, need for secondary reconstructive procedures related to absence of nerve regeneration (tendon transfer, neurolysis neuroma resection/reconstruction, etc.). As of 9/30/23, at least one site is certified and MCC is working with other participating sites on the certification process.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2023
- Accession Number
- AD1215025
Entities
People
- Ala Elhelali
- Cameron L Ghergherehchi
- Elias Weston-farber
- Elizabeth Wysocki
- Glenn Gaston
- Jamie Shores
- Jonathan Isaacs
- Joseph F Jr Alderete
- Lisa Reider
- Rachel Soifer
- Raymond Pensy
- Richard Trevino
- Rick Thompson
- Sami Tuffaha
- Suna Chung
Organizations
- Johns Hopkins University