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

Primary Purpose

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

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Polyethylene Glycols

About this trial

This is an interventional treatment trial for Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

WellSpanYork HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nerve injury to palm and fingers

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03236064

First Posted

July 25, 2016

Last Updated

January 22, 2021

Sponsor

WellSpan Health

Collaborators

Neuraptive Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03236064

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Recruiting

Study Start Date

May 2016 (undefined)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

WellSpan Health

Collaborators

Neuraptive Therapeutics Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nerve injury to palm and fingers

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Polyethylene Glycols

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Richard C Trevino, MD

Phone

717-812-4090

rctrevino@trevino6.com

First Name & Middle Initial & Last Name or Official Title & Degree

George Bittner, PhD

Phone

512-923-3735

bittner@austin.utexas.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard C Trevino, MD

Organizational Affiliation

WellSpan York Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

WellSpanYork Hospital

City

York

State/Province

Pennsylvania

ZIP/Postal Code

17405

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Richard C Trevino, MD

Phone

717-812-4090

rctrevino@trevino6.com

First Name & Middle Initial & Last Name & Degree

12. IPD Sharing Statement

Learn more about this trial

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

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