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

WellSpan Health

Status and phase

Unknown

Phase 1

Conditions

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

Treatments

Drug: Polyethylene Glycols

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03236064

696230-1

Details and patient eligibility

About

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

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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