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

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

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03236064
• Other study ID #: 696230-1
• Status: Recruiting
• Phase: Phase 1
• Start date: May 2016
• Est. completion date: May 2024

Study information

• Verified date: January 2021
• Source: WellSpan Health
• Contact: Richard C Trevino, MD
• Phone: 717-812-4090
• Email: rctrevino[@]trevino6.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Polyethylene Glycols
Demonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques

Locations

Country	Name	City	State
United States	WellSpanYork Hospital	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
WellSpan Health	Neuraptive Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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