Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration

Nova Scotia Health Authority (NSHA)

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Peripheral Nerve Injury; Nerve Injury

Treatments: Drug: Polyethylene Glycol 3350; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04270019

0644

Details and patient eligibility

About

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.

Sex: All

Ages: 16 to 120 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

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.

Treatment:

Drug: Polyethylene Glycol 3350

Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline