Nail bed INJury Analysis (NINJA) Definitive RCT
The definitive NINJA RCT is live across multiple sites in the UK. For more information check out the new website here. It has details about the trial protocol, current and future sites and recruitment rates. Thank you to all those sites involved!
Background
The NINJA Pilot Study (funded by the British Society for Surgery of the Hand, BSSH) was a pragmatic multicentre study to assess whether the nail should be replaced or discarded after nail bed repair in children. The pilot was completed in 2016 and used to inform the design and conduct of the definitive NINJA RCT. The Surgical Intervention Trials Unit (SITU) at the University of Oxford, is co-ordinating the trial.
PICO
Patients: Children under 16 with nail bed injury needing repair
Intervention: Replace nail plate after nail bed repair
Comparator: Discard nail plate after nail bed repair
Outcome: Co-primary outcome – infection at 7-10 days or 4 months and cosmetic appearance at 4 months post-repair.
NINJA updates
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Update 31/07/2018
Recruitment is live and we have a new NINJA website with up to date recruitment information across the sites: https://ninja.octru.ox.ac.uk/. Check this website for further updates.
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Update 26/02/2018
The first NINJA-RCT Trial Steering Committee meeting took place at the Botnar Research Centre in Oxford.
The trial has 9 sites approved and 21 waiting to be signed off.
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Update 30/10/2017
The NINJA-Pilot RCT has been published in the BJS. Click to download: http://onlinelibrary.wiley.com/doi/10.1002/bjs5.13/epdf
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Update 19/07/2017
The NINJA-Pilot RCT has been accepted for publication in the British Journal of Surgery.
The NINJA team is now recruiting sites for the main RCT. Please sign up below if you are interested.
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Update 07/04/2017
The NINJA RCT has been awarded funding by the NIHR RfPB (£350K). We are now recruiting units for the definitive trial. If you are interested, please sign up below.
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Update 01/04/2016
The team have submitted a first stage application to the NIHR RfPB panel for funding for a full trial.
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Update 01/01/2016
The NINJA-Pilot data is being analysed. The original audit data and clinician and patient surveys have been published as has the NINJA-P protocol. Details in the 'outputs' box.
Register to become a NINJA centre
The definitive NINJA trial is aiming to recruit from 20-30 units. The study is on the NIHR Portfolio meaning the hospital will receive funding for each patient recruited. Please sign up via this link: https://ninja.octru.ox.ac.uk/contact-us-14. Following the expression of interest your unit will undergo assessment for suitability.
Co-Chief Investigator
NDORMS, Oxford
Aina Greig
Co-Chief Investigator and PI at Lead Site
Guy’s and St Thomas’ NHS Foundation Trust
Dominic Furniss
Principal Investigator
Oxford University Hospitals NHS Trust
Claire Zweifel
Principal Investigator
Mid Essex Hospital Services NHS Trust
Richard Pinder
Principal Investigator
Hull and East Yorkshire Hospitals NHS Trust
David Beard
Co-director
SITU, Oxford
Jonathan Cook
Associate Professor
Centre for Statistics in Medicine, Oxford
Adam Sierakowski
Mid Essex Hospital Services NHS Trust
‘Trainee’ Lead, NINJA Study Group
Matthew D. Gardiner
Trainee Lead, RSTN
Cushla Cooper
Research Portfolio Manager
SITU, Oxford
Nicola Farrar
Clinical Trials Administrator
SITU, Oxford
Reconstructive Surgery Trials Network Nail bed INJury Analysis (NINJA) Collaborative
This group conducted the audit, clinician and patient surveys.
Frank Acquaah, Sadia Afzal, Shirwa Sheik Ali, David Beard, Kamal Bisarya, David Bruce, Jonathan Cook, Cushla Cooper, Nicola Farrar, Dominic Furniss, Jenifa Jeyakumar, Max Horwitz, Hawys Lloyd-Hughes, Natalie Pease, Gordon McArthur, Adrian Murphy, Julia Ruston, Hassan Soueid, Makarand Tare, Ricardo Tejero, Evgenia Theodorakopoulou and Claire Zweifel.
NINJA Pilot Collaborative
Guy’s and St Thomas’ NHS Foundation Trust: Riaz Agha, Waleed Albadry, Yeliz Cemal, Priyanka Chadha, Declan Collins, Henrietta Creasy, Asmat Din, Magda Ferreira, Federica Maggiulli, Antonios Mitsakos, Alexandra Molina, Tom Pampiglione, Matthew Pywell, Karen Richards, Yasmin Tavsanoglu, Ricardo Tejero, Sarita Vamadeva, Ruby Wang, Matthew Wordsworth. Hull Royal Infirmary: Will Holmes, James Haeney, Neil Brierley, Elaine Pardoe, Charde Naylor. Mid Essex Hospital Services NHS Trust: Tereze Laing, Iraklis Delikonstantinou, Natalie Whybro, Helen Gerrish. Oxford University Hospitals NHS Trust: Emma Gammin.
University of Oxford
BSSH £27,000
Gardiner MD, Jain A, Sierakowski A, Grieg A on behalf of the RSTN NINJA Collaborative*. Results of a national survey of nail bed repair practice. BSSH Autumn Scientific Meeting 2014, London
Greig A on behalf of the NINJA Pilot Trial Group*. Nail bed INJury Analysis (NINJA). BAPRAS Winter Scientific Meeting 2015, Birmingham.
Publications
Sierakowski A, Gardiner MD, Jain A, Grieg A and RSTN NINJA Collaborative*. Surgical treatment of paediatric nail bed injuries in the United Kingdom: Surgeon and patient priorities for future research. JPRAS 2015. In press.
Jain A, Sierakowski A, Gardiner MD, Beard D, Cook J, Cooper C, Greig A. Nail bed INJury Assessment Pilot (NINJA-P) study: should the nail plate be replaced or discarded after nail bed repair in children? study protocol for a pilot randomised trial. Pilot and Feasibility Studies 2015. 1-29.
*See collaborators section
ninja@ndorms.ox.ac.uk