Clinical trial

The Use of Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration: A Randomized Controlled Trial

Name

0644

Description

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.

Trial arms

Trial start

2020-06-26

Estimated PCD

2023-09-15

Trial end

2023-09-15

Status

Withdrawn

Phase

Early phase I

Treatment

Polyethylene Glycol 3350

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.

Arms:

Experimental

Normal Saline

Standard solution of sterile normal saline.

Arms:

Control

Primary endpoint

Change in Sensory Recovery

Testing to be done at one month, three months, and six months post-operatively.

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

Protocol

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Updated at

2024-01-05

1 organization

1 product

1 drug

2 indications

Organization

Nova Scotia Health Authority

Product

Polyethylene Glycol 3350

Indication

Peripheral Nerve Injury

Indication

Nerve Injury

Drug

Varlilumab