Trials Sponsors Conditions Drugs Pricing

Conditions

Peripheral Nerve Injury

Outcome Measures

Primary Outcomes (1)

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

Study Arms (6)

standard epineural repair <24 hours

NO 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

standard epineural repair >24 - 72 hours

NO 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

epineural repair with autografting within 48 hours

NO INTERVENTION

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

epineural repair <24 hours using PEG

Interventions

Polyethylene glycol (PEG)Drug

For the control groups, epineural repair or interposition grafting will be undertaken in the standard end-to-end fashion using interrupted nylon suture after irrigation of the wound with normal saline as deemed necessary by the operating surgeon. For the experimental group, the nerve(s) will be repaired using standard suture neurorrhaphy techniques and a 149.25 mM (50%) solution of PEG 3.35 kD in sterile water will then be irrigated onto the neurorrhaphy site for one minute. Following this, the approximated nerve ends will be irrigated with sterile water gently for 2 minutes. All wounds will be closed in the fashion deemed appropriate by the operating surgeon.

Also known as: PEG

epineural repair <24 hours using PEGepineural repair >24 but <72 hours using PEGepineural repair with autografting within 48 hours, using PEG

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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);

Sponsors & Collaborators

Vanderbilt University Medical Center
Otherlead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

MeSH Terms

Conditions

Peripheral Nerve Injuries

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymers

Study Officials

Wesley Thayer, MD
Vanderbilt University Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

45 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MD, PHD

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 10, 2015

Study Start

September 19, 2019

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (6)

standard epineural repair <24 hours

standard epineural repair >24 - 72 hours

epineural repair with autografting within 48 hours

epineural repair <24 hours using PEG

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

epineural repair >24 but <72 hours using PEG

epineural repair with autografting within 48 hours, using PEG

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (6)

standard epineural repair <24 hours

standard epineural repair >24 - 72 hours

epineural repair with autografting within 48 hours

epineural repair <24 hours using PEG

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

epineural repair >24 but <72 hours using PEG

epineural repair with autografting within 48 hours, using PEG

You may not qualify if:

Source record

Documents

Locations