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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The overall objective of this study is to determine the safety of PEG fusion when used with primary repair or reconstruction in patients with an acute upper extremity peripheral nerve injury. PEG is safe and effective for extending the half-life of circulating pharmaceutical products, when used in conjunction with a topical hemostatic agent in surgical wounds, and when used as a colon cleanser for endoscopic surgical procedures. However, PEG fusion has not been rigorously tested as a safe reagent to promote nerve regeneration in humans. Therefore, the goal of this Phase 2a clinical trial is to establish safety data and to examine the effect of PEG fusion on clinical outcomes including recovery of sensory and motor function. Results will be externally validated using data collected in the DoD funded prospective NERVE study and will provide preliminary evidence to power a larger phase II efficacy trial.
The study will enroll 40 patients receiving autograft reconstruction within 24 hours of injury. Patients will be randomized to either PEG mediated reconstruction (n=20); or conventional nerve reconstruction (n=20). The investigators hypothesize that (1) the rate of complications within 1 month of surgery in patients treated with PEG fusion will be comparable to that of patients treated with conventional autograft reconstruction, (2) there will be no detrimental effects from PEG fusion on nerve regeneration over 2 years compared to patients treated with conventional nerve reconstruction, ((3) recovery of sensory and motor function will occur earlier (within 6 months) among patients treated with PEG fusion compared to patients treated with conventional autograft reconstruction (4) patients treated with PEG fusion will have better range of motion, greater hand strength, less disability, less pain, and higher rates of treatment satisfaction compared with patients treated with conventional autograft reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG mediated reconstruction | Experimental | NTX-001 will be administered topically via isolation chamber medical device. Dose Unit: 2.5 mL NTX-001 is a single use surgical product intended for use as adjunct treatment in the repair of severed peripheral nerves in patients requiring standard suture neurorrhaphy. |
|
| Conventional nerve reconstruction | No Intervention | Conventional nerve reconstruction |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTX-001 | Drug | • PEG fusion is the application of a polyethylene glycol (PEG) using a combination of sequenced reagents to a freshly performed nerve coaptation, or neurorrhaphy, to allow the axonal membranes of the proximal and distal axonal stumps to fuse back together and re-establish full axonal continuity. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications or problems that occur with in the first 30 days. | Complications or problems include surgical site infections, wound dehiscence/breakdown, exposure of nerves and/or their repairs and reconstructions, breakdown of nerve repair or reconstruction, seroma/hematoma requiring an additional procedure to treat, and any other local wound complications related to the zone of nerve injury that require an additional surgical procedure | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Wysocki, MA | Contact | 410-955-0396 | ewysock2@jhu.edu | |
| Ala Elhelali, PhD | Contact | 443-220-2537 | aelhela1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ala Elhelali, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center Shock Trauma Center | Recruiting | Baltimore | Maryland | 21201 | United States |
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The study will enroll 40 patients receiving autograft reconstruction within 24 hours of injury. Patients within each group will be randomized to either PEG mediated reconstruction (n=20); or conventional nerve reconstruction (n=20).
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| Johns Hopkins University School of Medicine | Recruiting | Baltimore | Maryland | 21213 | United States |
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| Cooper Health | Recruiting | Camden | New Jersey | 08103 | United States |
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| OrthoCarolina | Recruiting | Charlotte | North Carolina | 28207 | United States |
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| Wellspan Health | Recruiting | York | Pennsylvania | 17403 | United States |
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| San Antonio Military Medical Center (SAMMC) | Recruiting | San Antonio | Texas | 78234 | United States |
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| Virginia Commonwealth University Medical Center | Recruiting | Richmond | Virginia | 23219 | United States |
|
| ID | Term |
|---|---|
| D059348 | Peripheral Nerve Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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