Nerve Injury Clinical Trial
Official title:
The Use of Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration: A Randomized Controlled Trial
Verified date | January 2024 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 15, 2023 |
Est. primary completion date | September 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years to 120 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Nova Scotia Health Authority |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Testing to be done at one month, three months, and six months post-operatively. | |
Secondary | Functional Recovery | Functional recovery assessed by the Michigan Health Questionnaire (MHQ). | Administered six months post-operatively. Maximum score of 100, minimum score of 0. A higher score means better functional recovery. |
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