Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury

This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.

Study Overview

• Status: Recruiting
• Conditions: Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter
• Intervention / Treatment: Drug: Polyethylene Glycols

Detailed Description

To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques. Neurorrhaphy is not new, being performed now for over 150 years much research has been performed. PEG-Axon fusion on the other hand is relatively new in mammals. Success has already been obtained by two institutions in the rat sciatic nerve transections, demonstrating rapid return of behavioral function4. These however are very controlled injuries and unclear how well these will translate into human studies. For this reason 3 separate clinical studies in increasing order of complexity are proposed.

The first study proposed will be PEG fusion in digital nerve lacerations. Two goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Richard C Trevino, MD; Phone Number: 717-812-4090; Email: rctrevino@trevino6.com
• Study Contact Backup: Name: George Bittner, PhD; Phone Number: 512-923-3735; Email: bittner@austin.utexas.edu

Study Locations

• United States
  • Pennsylvania
    • York, Pennsylvania, United States, 17405
      • Recruiting
      • WellSpanYork Hospital
      • Contact: Richard C Trevino, MD; Phone Number: 717-812-4090; Email: rctrevino@trevino6.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Isolated nerve transections of the digits, forearm, wrist, and palm will be included.
• Class III nerve injury (Sunderland's 4th or 5th degree injury)
• Nerve injuries that can be prepared using minimal or acceptable tension (according to surgeon discretion).
• Pregnant and breastfeeding women cannot participate because of possible unknown and unpredictable risks to the unborn child.
• Injuries beyond 24 hours will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nerve injury to palm and fingers; Adult patients with acute clean nerve transections of the higher arm injuries in the forearm, wrist, palm and digits of the hand will be recruited	Drug: Polyethylene Glycols; Demonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques	Three goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, rapid return of motor function and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure	12 months

Collaborators and Investigators

• Sponsor: WellSpan Health
• Collaborators: Neuraptive Therapeutics Inc.
• Investigators: Principal Investigator: Richard C Trevino, MD, Wellspan York Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 696230-1