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Hydrophilic Polymer

PEG Fusion Technique for Peripheral Nerve Injury

Q: Who is qualified to take part in this research endeavor?

This clinical trial seeks 18 volunteers, aged between 18 and 75, who have suffered a peripheral nerve injury within the past 72 hours. The subjects must also possess no major pre-existing medical conditions that would prevent surgical repair from taking place in 48 hours or less. In addition to agreeing to comply with <a href="https://www.withpower.com/clinical-trials/all">all</a> aspects of treatment for 12 months post-surgery, participants should present complications due to vascular or <a href="https://www.withpower.com/clinical-trials/orthopedic">orthopedic</a> damage as well.

Q: What hazards are associated with Polyethylene glycol (PEG) usage?

After assessing the risk-benefit ratio, our team at Power has rated Polyethylene glycol (PEG) as a 1. This is due to its Phase 1 classification, meaning that safety and efficacy have been demonstrated in limited studies.

Q: Does the eligibility criteria for this medical study encompass individuals under 30 years old?

According to the trial's criteria, applicants aged 18-75 are eligible for this study. Additionally, there exist 3 trials specifically catered towards those below 18 and a dozen studies targeting seniors above 65 years old.

Q: Is recruitment for this investigation closed or still ongoing?

Affirmative. Clinicaltrials.gov displays that this medical trial, first announced on September 1st 2015 is actively recruiting. A total of 18 participants are being sought from a single site.

Q: How many individuals are taking part in this research?

Affirmative. Clinicaltrials.gov confirms that this experiment, which was initially posted on September 1st 2015, is actively searching for 18 participants at one location. It has been recently updated on October 28th 2021.

Phase 1

Recruiting

Led By Wesley Thayer, MD

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidates for immediate operative repair (Arm 1)

Repair within 48 hours of injury that require nerve grafting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will test a new technique to help repair peripheral nerve injuries. The goal is to improve clinical outcomes by restoring function more quickly.

Who is the study for?

This trial is for individuals with a specific type of severe nerve injury in the upper extremity, known as Sunderland Class 5. They must be candidates for immediate surgery, with injuries no older than 72 hours and ready to commit to a year-long treatment and evaluation schedule. Excluded are those with contaminated wounds, inadequate tissue coverage, diabetes, neuromuscular diseases, or undergoing treatments affecting neural growth.Check my eligibility

What is being tested?

The study tests polyethylene glycol (PEG) assisted axonal fusion technique for repairing peripheral nerve injuries. It aims to see if this method can rapidly restore function after an injury by immediately fusing severed nerves together during surgery.See study design

What are the potential side effects?

While the side effects of PEG-assisted axonal fusion aren't detailed here, similar procedures may cause localized pain at the site of repair, possible inflammation or infection risk around the treated area and allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a candidate for immediate surgery.

Select...

I had surgery to repair a nerve within 2 days of being injured.

Select...

I have nerve injuries with major blood vessel or bone damage.

Select...

I have a severe nerve injury in my hand or arm from a cut.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

return of nerve function as measured by (Medical Research Council Classificatoin (MRCC)

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: epineural repair with autografting within 48 hours, using PEGExperimental Treatment1 Intervention

epineural repair with auto grafting within 48 hours

Group II: epineural repair >24 but <72 hours using PEGExperimental Treatment1 Intervention

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

Group III: epineural repair <24 hours using PEGExperimental Treatment1 Intervention

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

Group IV: standard epineural repair <24 hoursActive Control1 Intervention

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

Group V: epineural repair with autografting within 48 hoursActive Control1 Intervention

epineural repair with auto grafting within 48 hours; no medication used

Group VI: standard epineural repair >24 - 72 hoursActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Polyethylene glycol (PEG)

2016

Completed Phase 4

~1520

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor

704 Previous Clinical Trials

6,143,345 Total Patients Enrolled

Wesley Thayer, MDPrincipal Investigator - Vanderbilt University Medical Center

Sumner Regional Medical Center, Williamson Medical Center

Emory University School Of Medicine (Medical School)

Vanderbilt University Medical Center (Residency)

2 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

Polyethylene glycol (PEG) (Hydrophilic Polymer) Clinical Trial Eligibility Overview. Trial Name: NCT02359825 — Phase 1

Peripheral Nerve Injury Research Study Groups: epineural repair >24 but <72 hours using PEG, epineural repair <24 hours using PEG, epineural repair with autografting within 48 hours, using PEG, standard epineural repair <24 hours, epineural repair with autografting within 48 hours, standard epineural repair >24 - 72 hours

Peripheral Nerve Injury Clinical Trial 2023: Polyethylene glycol (PEG) Highlights & Side Effects. Trial Name: NCT02359825 — Phase 1

Polyethylene glycol (PEG) (Hydrophilic Polymer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02359825 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is qualified to take part in this research endeavor?

"This clinical trial seeks 18 volunteers, aged between 18 and 75, who have suffered a peripheral nerve injury within the past 72 hours. The subjects must also possess no major pre-existing medical conditions that would prevent surgical repair from taking place in 48 hours or less. In addition to agreeing to comply with all aspects of treatment for 12 months post-surgery, participants should present complications due to vascular or orthopedic damage as well."

Answered by AI

What hazards are associated with Polyethylene glycol (PEG) usage?

"After assessing the risk-benefit ratio, our team at Power has rated Polyethylene glycol (PEG) as a 1. This is due to its Phase 1 classification, meaning that safety and efficacy have been demonstrated in limited studies."

Answered by AI

Does the eligibility criteria for this medical study encompass individuals under 30 years old?

"According to the trial's criteria, applicants aged 18-75 are eligible for this study. Additionally, there exist 3 trials specifically catered towards those below 18 and a dozen studies targeting seniors above 65 years old."

Answered by AI

Is recruitment for this investigation closed or still ongoing?

"Affirmative. Clinicaltrials.gov displays that this medical trial, first announced on September 1st 2015 is actively recruiting. A total of 18 participants are being sought from a single site."

Answered by AI

How many individuals are taking part in this research?

"Affirmative. Clinicaltrials.gov confirms that this experiment, which was initially posted on September 1st 2015, is actively searching for 18 participants at one location. It has been recently updated on October 28th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function

Wesley Thayer 2015. "Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02359825.

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