Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter
Conditions
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.
Interventions
Demonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques
Sponsors
Neuraptive Therapeutics Inc.
WellSpan Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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. * Injuries beyond 24 hours will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques | 12 months | 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 |
Countries
United States
Contacts
Primary ContactRichard C Trevino, MD
Backup ContactGeorge Bittner, PhD
Outcome results
None listed