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
The date of last modification
Aug 26, 2022
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
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)
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• 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 |
[ Post-operative week 12, 24 36, and 48. ] |
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• 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. |
[ Post-operative week 12, 24, 36 and 48. ] |
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• Parameter- Adverse outcomes following nerve repair with PEG fusion using clinical assessment |
[ Any timepoint up to 48 weeks post-operatively ] |
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Secondary outcome(s)
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• 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 ] |
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• 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. |
[ Post-operative weeks 1,2,3,4,6, 8, 12, 16, 24, 36 and 48 ] |
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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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• 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. |
[ 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
2021-10-30
Date of study completion
Recruitment status
Recruiting
Funding source
Self-funded
Regulatory approvals
Not relevant
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 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
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
