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

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

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.

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

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

Intervention / Treatment
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* Drug: Polyethylene Glycols


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerve injury to palm and fingers<br>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<br>* Demonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |