Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
Peripheral Nerve Injury
About this trial
This is an interventional treatment trial for Peripheral Nerve Injury
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of a Sunderland Class 5 traumatic neuropathy (transection injury) of a digital nerve in the upper extremity
- candidates for immediate operative repair (Arm 1);
- injury proceeding repair no longer than 72 hours; and
- repair within 48 hours of injury that require nerve grafting;
- N0 significant medical comorbidities precluding immediate repair;
- willing to comply with all aspects of the treatment and evaluation schedule over a 12 months period.
We plan to include subjects who have peripheral nerve injuries that are complicated by significant vascular or orthopedic damage.
Exclusion Criteria:
- Patients will be excluded from enrollment if their injuries exhibit gross contamination, in circumstances where soft tissue coverage is inadequate, or when staged repair is planned.
- We will also exclude patients that are diabetic, have been diagnosed with a neuromuscular disease, or are undergoing chemotherapy, radiation therapy, or other treatments known to affect the growth of the neural and vascular system.
- We will exclude all patients currently enrolled in another investigational study or those who are unlikely to complete the normal regime of occupational therapy. Individuals will be excluded from participation if their time of injury falls outside study parameters.
Sites / Locations
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
No Intervention
No Intervention
No Intervention
Experimental
Experimental
Experimental
standard epineural repair <24 hours
standard epineural repair >24 - 72 hours
epineural repair with autografting within 48 hours
epineural repair <24 hours using PEG
epineural repair >24 but <72 hours using PEG
epineural repair with autografting within 48 hours, using PEG
epineural repair following treatment with standard epineural repair alone in sensory nerve injuries in the upper extremity in short-term acute injuries (repaired <24 hours after injury); no medication used
epineural repair following irrigation with standard epineural repair alone in sensory nerve injuries in the upper extremity in short-term chronic injuries (>24-<72 hours after injury); no medication used
epineural repair with auto grafting within 48 hours; no medication used
epineural repair following treatment with standard epineural repair using PEG in sensory nerve injuries in the upper extremity in short-term acute injuries (repaired <24 hours after injury); PEG is used during the surgical procedure
epineural repair following treatment with standard epineural repair using PEG in sensory nerve injuries in the upper extremity in short-term acute injuries (repaired >24 hours but < 72 hours after injury); PEG is used during the surgical procedure
epineural repair with auto grafting within 48 hours