Condition category
Injury, Occupational Diseases, Poisoning
Date applied
25/03/2019
Date assigned
21/05/2019
Last edited
06/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Peripheral nerve injuries result in a loss of sensation to crucial areas of the hand. Alongside this, there is a loss of sweating and changes to the skin of the affected area. This study aims to assess whether it is possible to assess these skin changes in nerve-injured patients in order to examine if they can be used to monitor recovery of sensation in patients who have undergone treatment.

Who can participate?
Patients over 18 years old who are attending Wythenshawe Hospital, Department of Plastic Surgery with a nerve injury in their forearm

What does the study involve?
Skin changes are measured using OCT (Optical Coherence Tomography) imaging, a non-invasive device. The researchers also aim to investigate whether detailed three-dimensional ultrasound (similar to pregnancy scans) can be used to monitor nerve regeneration at the operation repair site. This imaging tool is non-invasive can be used to determine how fast the nerve is re-growing and also the volume of the re-growing nerve.

What are the possible benefits and risks of participating?
There will be no effect on the patients’ normal care pathway or surgery. There is no anticipated risk to patients. The imaging devices used are non-invasive and do not cause harm to patients.

Where is the study run from?
Wythenshawe Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2018 to August 2022 (updated 06/08/2020, previously: July 2020)

Who is funding the study?
1. British Association Of Plastic Reconstructive And Aesthetic Surgeons
2. Royal College of Surgeons of England

Who is the main contact?
1. Mr Bradley Tallon
Bradley.tallon@mft.nhs.uk
2. Mr Ralph Murphy
Ralph.murphy@manchester.ac.uk
3. Mr Adam J Reid
Adam.Reid@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Bradley Tallon

ORCID ID

Contact details

Clinical Trials Manager – Burns
Plastics & Critical Care
Research & Innovation
1st Floor - NIHR Building
Wythenshawe Hospital
Manchester University NHS Foundation Trust
Southmoor Road
Manchester
M23 9QZ
United Kingdom
+44 (0)161 291 5757
Bradley.tallon@mft.nhs.uk

Type

Scientific

Additional contact

Mr Ralph Murphy

ORCID ID

Contact details

Principal Investigator
Department of Academic Surgery
Educational and Research Centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
+44 (0)161 291 5823
Ralph.murphy@manchester.ac.uk

Type

Scientific

Additional contact

Mr Adam J Reid

ORCID ID

http://orcid.org/0000-0003-1752-3302

Contact details

Chief Investigator
Department of Plastic Surgery & Burns
Wythenshawe Hospital
Manchester University NHS Foundation Trust
Blond McIndoe Laboratories
School of Biological Sciences
Faculty of Biology
Medicine and Health
Rm 3.102 Stopford Building
The University of Manchester
Manchester
M13 9PG
United Kingdom
+44 (0)161 275 1596
Adam.Reid@manchester.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

40584

Study information

Scientific title

Novel Outcome measures in Peripheral Nerve injury (OPEN study)

Acronym

OPEN

Study hypothesis

Will changes in: sweat gland density and epidermal thickness as measured by OCT and volume and growth of the regenerating nerve as measured by high-frequency 3D ultrasound, correspond to changes in current sensory outcome measures (two-point discrimination (2PD), locognosia, Weinstein Enhanced Sensory Test (WEST) monofilament and STI Test) and patient-reported outcome measures (DASH and i-Hand) following peripheral nerve repair.

Ethics approval

Approved 25/01/2019, East Midlands – Nottingham 1 Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; Tel: +44 (0)207 104 8101; Email: NRESCommittee.eastmidlands-nottingham1@nhs.net), ref: 18/EM/0426

Study design

Non-randomised; Interventional; Design type: Screening, Device, Imaging, Active Monitoring

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Peripheral nerve injury

Intervention

There are no study ‘interventions’ as such, just additional imaging measurements. These are as follows:
Date of surgery (or within 7 days post-op): OCT scanning, high frequency 3D ultrasound scan (Hf,3D,USS), sensory outcome measures and PROMs
Week 2: OCT scanning, high frequency 3D ultrasound scan (Hf,3D,USS), sensory outcome measures and PROMs
Week 6: OCT scanning, high frequency 3D ultrasound scan (Hf,3D,USS), sensory outcome measures and PROMs
Month 3: OCT scanning, high frequency 3D ultrasound scan (Hf,3D,USS), sensory outcome measures and PROMs
Month 6: OCT scanning, high frequency 3D ultrasound scan (Hf,3D,USS), sensory outcome measures and PROMs
Month 12: OCT scanning, high frequency 3D ultrasound scan (Hf,3D,USS), sensory outcome measures and PROMs

Intervention type

Other

Phase

Drug names

Primary outcome measure

Measured at date of surgery (or within 7 days post-op), weeks 2 and 6, and months 3, 6 and 12:
1. Sweat gland density and epidermal thickness measured by Optical Coherence Tomography
2. Regenerative rate and volume of the regenerating nerve measured by high-frequency, three-dimensional ultrasound

Secondary outcome measures

Sensory outcome measures:
1. Tactile spatial discrimination measured using 2 Point Discrimination Test at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12
2. Pressure detection threshold measured using Weinstein Enhanced Sensory Test (WEST) monofilament at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12
3. Tactile spatial discrimination measured using locognosia at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12
4. Stereogenesis measured using Shape/Texture Identification Test at months 6 and 12

Motor outcome measures:
1. Individual muscle strength measured using manual muscle testing (MRC Grading) at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12
2. Grip strength measured using Jamar Dynamometer at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12

Patient-Reported Outcome Measures (PROMs):
1. Functional disability and pain caused by nerve injury measured using DASH and i-HAND at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12

Overall trial start date

01/10/2018

Overall trial end date

04/08/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18 – 80 years old
2. Peripheral nerve injury of ulnar or median nerve (or both) distal to the elbow
3. Having direct, epineural surgical repair within 1 week after injury
4. Capacity to consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 15; UK Sample Size: 15

Participant exclusion criteria

1. Outside of stated age range
2. Outside stated location of injury
3. Nerve gap requiring alternative surgical management
4. Lacks capacity to consent

Recruitment start date

01/05/2019

Recruitment end date

30/04/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wythenshawe Hospital
Manchester University NHS Foundation Trust Southmoor Road
Manchester
M23 9QZ
United Kingdom

Sponsor information

Organisation

The University of Manchester

Sponsor details

c/o Ms Lynne Macrae
Faculty Research Practice Governance Manager
Faculty of Biology
Medicine and Health
Room 5.012 Carys Bannister Building
-
M13 9PL
United Kingdom
+44 (0)1612755436
fbmhethics@manchester.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Association Of Plastic Reconstructive And Aesthetic Surgeons (BAPRAS)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal College of Surgeons of England

Alternative name(s)

RCS

Funding Body Type

private sector organisation

Funding Body Subtype

Associations and societies (private and public)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The main study results will be published in the name of the study, in a peer-reviewed journal, on behalf of all collaborators.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

04/08/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/08/2020: The following changes were made to the trial record: 1. The overall end date was changed from 31/07/2020 to 04/08/2022. 2. The intention to publish date was changed from 31/07/2021 to 04/08/2023. 3. The plain English summary was updated to reflect these changes. 20/04/2020: Due to current public health guidance, recruitment for this study has been paused. 25/03/2019: Trial's existence confirmed by the NIHR.