Home » Trials » SLCTR/2021/029


A single arm phase II clinical trial to assess safety, efficacy and feasibility of Polyethylene Glycol (PEG) fusion in nerve repair following acute transection of median and/or ulnar nerves in adults

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SLCTR Registration Number

SLCTR/2021/029


Date of Registration

22 Oct 2021

The date of last modification

Oct 22, 2021



Application Summary


Scientific Title of Trial

A single arm phase II clinical trial to assess safety, efficacy and feasibility of Polyethylene Glycol (PEG) fusion in nerve repair following acute transection of median and/or ulnar nerves in adults


Public Title of Trial

A clinical trial to assess whether the new nerve repair technique (PEG fusion) is safe and effective in adults with traumatic complete cuts involving large nerves in the forearm.


Disease or Health Condition(s) Studied

Peripheral nerve injuries


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

AU1111-1269-8432


Any other number(s) assigned to the trial and issuing authority

EC-21-052: FMC,UOC


Trial Details


What is the research question being addressed?

Is repair of completely transected median and/or ulnar nerves in adults using Polyethylene glycol (PEG) fusion safe and effective?


Type of study

Interventional


Study design

Allocation

Single arm study


Masking

Masking not used


Control

Uncontrolled


Assignment

Single


Purpose

Treatment


Study Phase

Phase 2


Intervention(s) planned

The study will be conducted in Plastic and Reconstructive Surgical Unit of National Hospital of Sri Lanka .

Eligibility criteria matching (at preoperative stage) consented patients will be included. They will undergo a Nerve Conduction Study (NCS) before subjecting to general anaesthesia as described below. The patients will be operated under general anaesthesia. Total intravenous anaesthesia or general anaesthesia without muscle paralysis will be utilized with the intent of using intra operative NCS. The routine surgical steps will be followed as required including wound debridement, assessment and repair of tendons, muscles and vessels, wound closure and application of dressings and splints. At the assessment stage, selection of suitable candidates for the study will be done considering the inclusion criteria item c and exclusion criteria item b. Another NCS will be done before commencing nerve repair procedure. The criteria matching subjects will be offered primary neurorrhaphy with (Polyetheleneglycol) PEG fusion protocol. The excluded subjects will undergo primary neurorrhaphy and will receive the routine care postoperatively and they will be informed the reason why they were excluded from the study. They will not be included in data analysis (Routine care for these patients includes occupational therapy and clinic reviews as clinically indicated).

In selected subjects the PEG fusion protocol will be done. The nerve repair procedure will be done under operating microscope magnification.


Inclusion criteria

a. Age 18 years to 60 years b. Both males and females c. Admitted to accident and orthopedic services department of National Hospital of Sri Lanka d. Sustaining single complete cut injury to median and/or ulnar nerve at forearm (defined as the nerve is cut at or in between distal wrist crease and elbow flexion crease due to a sharp cutting mechanism. e.g., glass, sword, sharp knife) e. Nerve repair performed within 72 hours from the time of injury


Exclusion criteria

a. Patients who are unable to provide valid informed consent b. Patients sustaining injury to both radial and ulnar arteries in addition to nerve injury c. Patients sustaining simultaneous bilateral upper limb nerve/ tendon injury d. Patients with any past history of significant injury or disability of contralateral upper limb



Primary outcome(s)

1.

• Parameter- Disability after nerve repair with PEG fusion • Tool- DASH questionnaire Reference- DASH | Welcome to our website where you will find up-to-date information about the DASH Outcome Measure, the QuickDASH and related DASH [Internet]. [cited 2021 Jun 7]. Available from: https://dash.iwh.on.ca

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Post-operative week 12, 24 36, and 48.

]
2.

• Parameter- Functional and aesthetic outcome following nerve repair with PEG fusion • Tool- Michigan Hand Questionnaire Reference- KC, Pillsbury MS, Walters MR, Hayward RA. Reliability and validity testing of the Michigan Hand Outcomes Questionnaire. J Hand Surg. 1998 Jul 1;23(4):575–87.

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Post-operative week 12, 24, 36 and 48.

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3.

• Parameter- Adverse outcomes following nerve repair with PEG fusion using clinical assessment

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Any timepoint up to 48 weeks post-operatively

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Secondary outcome(s)

1.

• Parameter- Sensory recover following nerve repair with PEG fusion • Tools - 1. Modified British Medical Research Council sensory grading 2. Semmes-Weinstein Monofilament Test 3. Two Point Discrimination Test 4. Mini Sollerman Test

Modified British Medical Research Council (MMRC) motor grading (M0-M5) - The MMRC motor score measures the function of the muscles; on a scale from M0 to M5; the higher score indicates better strength

[

Post-operative weeks 1,2,3,4, 6,8, 12, 16, 24, 36 and 48

]
2.

• Parameter- Motor recovery following nerve repair with PEG fusion • Tools- 1. Manual muscle testing 2. Modified British Medical Research Council muscle strength grading 3. Pinch muscle strength 4. Grip strength 5. Mini Sollerman Test

Pinch muscle strength- Key pinch and pulp pinch will be assessed using ‘Pinch Gauge’. The nominal value of isometric force is measured in pounds. Normal value for key pinch is 13-20 pounds and for pulp pinch is 5-10 pounds

The Grip strength- evaluated using Jamar Dynamometer that measures strength in pounds. Mean of three trails of the injured/operated hand is compared as a percentage of the strength of the normal hand.

Mini Sollerman test- The test assesses dexterity.

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Post-operative weeks 1,2,3,4,6, 8, 12, 16, 24, 36 and 48

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3.
  • Parameter- Pain and discomfort following nerve repair with PEG fusion • Tool - Numerical Rating Scale [In-house]

Numerical Rating Scale - measures pain intensity on a scale from 0 representing no pain and 10 to the worst. .

[

Post-operative weeks 1,2,3,4, 6,8, 12, 16, 24, 36 and 48

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4.

• Parameter- Neurophysiological outcomes following nerve repair with PEG fusion • Tools- 1. Nerve Conduction Study (NCS) 2. Electromyography (EMG)

Neurophysiological outcomes NCS- Conduction velocity, distal latency and amplitude (sensory, motor and mixed) for the relevant nerve, proximal to, distal to and across the coaptation site. EMG- Appearance of volitional motor unit activation of the muscles of the injured nerve (Median: Abductor Pollicis Brevis -APB, Ulnar: Abductor Digiti Minimi -ADM and First Dorsal Interossei- FDI)

• References for secondary outcome parameters and tools- 1. Wang Y, Sunitha M, Chung KC. How to measure outcomes of peripheral nerve surgery. Hand Clin. 2013/06/14 ed. 2013 Aug;29(3):349–61. Electrodiagnosis in diseases of nerve and muscle: principles and practice. New York: Oxford University Press; 2001. p 131– 151.

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Post-operative weeks 1,2,3,4,6, 8, 12, 16, 24, 36 and 48

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Target number/sample size

20


Countries of recruitment

Sri Lanka


Anticipated start date

2021-10-25


Anticipated end date

2023-04-24


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self-funded


Regulatory approvals

Not relevant



State of Ethics Review Approval


Status

Approved


Date of Approval

2021-08-19


Approval number

EC-21-052


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Colombo.
Institutional Address:Ethics Review Committee, Faculty of Medicine, University of Colombo, No.25, Kynsey Road, Colombo – 08, Sri Lanka.
Telephone:+94 112 695 300 ext: 240
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Jeewan Pradeep Rankothkumbura
Senior Registrar in Plastic and Reconstructive Surgery
National Hospital Of Sri Lanka, Colombo 10

+94773090582

jeewan.med@gmail.com

Contact Person for Public Queries

Dr. Gayan Ekanayake
Plastic and Reconstructive Surgeon
National Hospital Of Sri Lanka, Colombo 10

10 +94767262902

gayanse2003@yahoo.com


Primary study sponsor/organization

Dr. Gayan Ekanayake
Consultant Plastic and Reconstructive Surgeon
National Hospital Of Sri Lanka, Colombo 10
+94767262902

gayanse2003@yahoo.com

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

All individual participant data collected during the trial, after de-identification will be shared upon reasonable request. The study protocol, the statistical analysis and data will be shared following publication of the results. Data will be shared among investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared to achieve the aims in an approved proposal. Proposals should be directed to jeewan.med@gmail.com . To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication at the National Plastic Surgical Service data warehouse.


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results