Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration

Phase 1

Withdrawn

• Conditions: Nerve Injury; Peripheral Nerve Injury
• Interventions: Drug: Normal Saline; Drug: Polyethylene Glycol 3350

• Registration Number: NCT04270019
• Lead Sponsor: Nova Scotia Health Authority

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-17
• Study Start: 2020-06-26
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

• (1) patients with cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Normal Saline	This group will receive normal saline applied to the nerve coaptation site during primary repair of peripheral nerve injury in the hand.
Experimental	Polyethylene Glycol 3350	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.

Primary Outcome Measures

Name	Time	Method
Change in Sensory Recovery	Testing to be done at one month, three months, and six months post-operatively.	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

Name	Time	Method
Functional Recovery	Administered six months post-operatively. Maximum score of 100, minimum score of 0. A higher score means better functional recovery.	Functional recovery assessed by the Michigan Health Questionnaire (MHQ).