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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2024-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Polyethylene Glycols

Intervention Type DRUG

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

Interventions

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Polyethylene Glycols

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.