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.

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2021/029

Enrollment

Registered

2021-10-22

Start date

2021-10-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral nerve injuries

Interventions

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.

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
• 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.] • 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.] • Parameter- Adverse outcomes following nerve repair with PEG fusion using clinical assessment [ Any timepoint up to 48 weeks post-operatively] [] []	—

Measure

Time frame

• 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.] • 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.] • 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

Measure	Time frame
• 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 ] • 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 ] * 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 ] • 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 o	—

Measure

Time frame

• 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 ] • 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 ] * 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 ] • 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 o

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Countries

Sri Lanka

Contacts

Public ContactDr. Jeewan Pradeep Rankothkumbura

Senior Registrar in Plastic and Reconstructive Surgery

jeewan.med@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026