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
About this trial
This is an interventional treatment trial for Peripheral Nerve Injury
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
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
NCT ID
NCT04270019
First Posted
February 12, 2020
Last Updated
July 13, 2020
Sponsor
Nova Scotia Health Authority
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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