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Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration

Primary Purpose

Peripheral Nerve Injury, Nerve Injury

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Polyethylene Glycol 3350
Normal Saline
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Nerve Injury

Eligibility Criteria

16 Years - 120 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • (1) surgery within twenty-four hours of injury (2) surgery completed in the minor procedures unit of the Halifax Infirmary.

Exclusion Criteria:

  • (1) patients with cognitive impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental

    Control

    Arm Description

    This group will receive polyethylene glycol (50% weight/volume) applied to the nerve coaptation site during primary repair of peripheral nerve injury in the hand.

    This group will receive normal saline applied to the nerve coaptation site during primary repair of peripheral nerve injury in the hand.

    Outcomes

    Primary Outcome Measures

    Change in Sensory Recovery
    Sensory recovery will be assessed by a blinded and trained OT through standardized testing with static two point discrimination (s2PD) and Semmes-Weinstein monofilament testing (SWMT). The end point will be composite in nature as both s2PD and SWMT are important to gauge and are the gold standards in determining sensory recovery.

    Secondary Outcome Measures

    Functional Recovery
    Functional recovery assessed by the Michigan Health Questionnaire (MHQ).

    Full Information

    First Posted
    February 12, 2020
    Last Updated
    July 13, 2020
    Sponsor
    Nova Scotia Health Authority
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04270019
    Brief Title
    Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration
    Official Title
    The Use of Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nova Scotia Health Authority

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    PEG is a fusogen, a type of chemical that aids in mediating cell fusion. PEG helps nerve cells recover neuronal continuity by removing plasmalemmal-bound water which opens the axonal ends on both sides of the injury. Opening axonal ends permits the nerve ends to reconnect and begin regeneration. PEG has been tested on animal models extensively and in earthworm models has been shown to induce fusion rates in 80-100% of neuronal cells. In crushed or severed mammalian sciatic nerves PEG has enhanced neuronal continuity to baseline functioning levels. Human applications for PEG have been tested by Bamba and colleagues in a case series with encouraging results. No studies, to our knowledge, have prospectively examined the use of PEG in peripheral nerve injuries. We propose a placebo controlled, double-blinded randomized controlled trial to test the hypothesis that local PEG administration can enhance sensory nerve regeneration following digital nerve transection compared to surgery alone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Nerve Injury, Nerve Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    This study will be a randomized, double-blind, placebo-controlled human clinical trial.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    This group will receive polyethylene glycol (50% weight/volume) applied to the nerve coaptation site during primary repair of peripheral nerve injury in the hand.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    This group will receive normal saline applied to the nerve coaptation site during primary repair of peripheral nerve injury in the hand.
    Intervention Type
    Drug
    Intervention Name(s)
    Polyethylene Glycol 3350
    Intervention Description
    In order to prepare PEG 3350 50% weight/volume, 25 grams of the sterilized PEG 3350 will be measured out and placed into a sterilized glass bottle then 25 mL of sterile water will be added. The solution will be allowed to rest for 10 minutes so that dissolution may occur. More sterile water will then be added so the total volume is 50mL. This solution will then be sterilized by the Halifax Health Infirmary pharmacy department using a liquid autoclave cycle of 120 degrees Celsius for 20 minutes in a glass vial. The 50 mL solution will be portioned into 2mL sterilized glass vials using a standard aseptic technique. The solutions will be kept at a solid frozen state between negative 25 degrees Celsius and negative 10 degrees Celsius for a maximum of 45 days. The solutions will be removed from storage on the day of surgical utilization in order to ensure storage guidelines are kept to the highest standards.
    Intervention Type
    Drug
    Intervention Name(s)
    Normal Saline
    Intervention Description
    Standard solution of sterile normal saline.
    Primary Outcome Measure Information:
    Title
    Change in Sensory Recovery
    Description
    Sensory recovery will be assessed by a blinded and trained OT through standardized testing with static two point discrimination (s2PD) and Semmes-Weinstein monofilament testing (SWMT). The end point will be composite in nature as both s2PD and SWMT are important to gauge and are the gold standards in determining sensory recovery.
    Time Frame
    Testing to be done at one month, three months, and six months post-operatively.
    Secondary Outcome Measure Information:
    Title
    Functional Recovery
    Description
    Functional recovery assessed by the Michigan Health Questionnaire (MHQ).
    Time Frame
    Administered six months post-operatively. Maximum score of 100, minimum score of 0. A higher score means better functional recovery.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: (1) surgery within twenty-four hours of injury (2) surgery completed in the minor procedures unit of the Halifax Infirmary. Exclusion Criteria: (1) patients with cognitive impairment

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration

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