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

NCT03236064 | Unknown Phase 1

• 1 other identifier: 696230-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Nerve injury to palm and fingers

EXPERIMENTAL

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

Interventions

Polyethylene Glycols DRUG

Demonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques

Nerve injury to palm and fingers

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• WellSpan Health: lead
• Neuraptive Therapeutics Inc.: collaborator

Study Sites (1)

WellSpanYork Hospital

York, Pennsylvania, 17405, United States

RECRUITING

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Richard C Trevino, MD

  WellSpan York Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard C Trevino, MD

CONTACT

717-812-4090; rctrevino@trevino6.com

George Bittner, PhD

CONTACT

512-923-3735; bittner@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 1, 2017
• Study Start: May 1, 2016
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

US (1)