A clinical trial to develop new ways of measuring nerve healing after injury
| ISRCTN | ISRCTN17886637 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17886637 |
| Secondary identifying numbers | 40584 |
- Submission date
- 25/03/2019
- Registration date
- 21/05/2019
- Last edited
- 18/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Contact information
Scientific
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
| Phone | +44 (0)161 291 5757 |
|---|---|
| Bradley.tallon@mft.nhs.uk |
Scientific
Principal Investigator
Department of Academic Surgery
Educational and Research Centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
| Phone | +44 (0)161 291 5823 |
|---|---|
| Ralph.murphy@manchester.ac.uk |
Scientific
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
 ORCID ID |
0000-0003-1752-3302 |
|---|---|
| Phone | +44 (0)161 275 1596 |
| Adam.Reid@manchester.ac.uk |
Study information
| Study design | Non-randomized; Interventional; Design type: Screening, Device, Imaging, Active Monitoring |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Novel Outcome measures in Peripheral Nerve injury (OPEN study) |
| 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(s) | 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 |
| 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 |
| 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 study start date | 01/10/2018 |
| Overall study end date | 04/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 15; UK Sample Size: 15 |
| Total final enrolment | 5 |
| 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 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 | 03/08/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southmoor Road
Manchester
M23 9QZ
United Kingdom
Sponsor information
University/education
c/o Ms Lynne Macrae
Faculty Research Practice Governance Manager
Faculty of Biology, Medicine and Health
Room 5.012 Carys Bannister Building
-
M13 9PL
England
United Kingdom
| Phone | +44 (0)1612755436 |
|---|---|
| fbmhethics@manchester.ac.uk | |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Charity
No information available
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- RCS
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 04/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| 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 plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 13/09/2023 | 15/09/2023 | Yes | No |
Editorial Notes
18/09/2023: IPD sharing statement added.
15/09/2023: Publication reference added.
19/08/2021: The total final enrolment was added.
28/09/2020: Recruitment to this study is no longer paused. The recruitment end date was changed from 30/04/2020 to 03/08/2021.
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.
