[x_section parallax=”true” bg_pattern=”https://reconstructivesurgerytrials.net/wp-content/uploads/2018/08/NailColourSized_0.png” style=”margin: 0px 0px 0px 0px; padding: 45px 0px 45px 0px; “][x_row inner_container=”true” marginless_columns=”false” bg_color=”” style=”margin: 0px auto 0px auto; padding: 0px 0px 0px 0px; “][x_column bg_color=”” type=”1/1″ style=”padding: 0px 0px 0px 0px; “][x_gap size=”150px”][/x_column][/x_row][/x_section][x_section style=”margin: 0px 0px 0px 0px; padding: 0px 0px 0px 0px; “][x_row inner_container=”true” marginless_columns=”false” bg_color=”” style=”margin: 0px auto 0px auto; padding: 0px 0px 0px 0px; “][x_column bg_color=”#ffffff” type=”2/3″ class=”left-text ” style=”padding: 0px 0px 0px 0px; “][x_gap size=”25px”][x_custom_headline level=”h2″ looks_like=”h3″ accent=”false”]Nail bed INJury Analysis (NINJA) Definitive RCT[/x_custom_headline][x_text]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![/x_text][x_custom_headline level=”h4″ looks_like=”h4″ accent=”false”]Background[/x_custom_headline][x_text]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.[/x_text][x_custom_headline level=”h4″ looks_like=”h4″ accent=”false”]PICO[/x_custom_headline][x_text]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.[/x_text][x_custom_headline level=”h4″ looks_like=”h4″ accent=”false”]NINJA updates[/x_custom_headline][x_feature_list][x_feature_box title=”Update 31/07/2018″ title_color=”” text=”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.” text_color=”” graphic=”icon” graphic_size=”30px” graphic_shape=”circle” graphic_color=”#ffffff” graphic_bg_color=”#b1005d” align_h=”left” align_v=”top” side_graphic_spacing=”20px” max_width=”none” child=”true” connector_width=”1px” connector_style=”dashed” connector_color=”#272727″ graphic_icon=”share-alt”][x_feature_box title=”Update 26/02/2018″ title_color=”” text=”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. ” text_color=”” graphic=”icon” graphic_size=”30px” graphic_shape=”circle” graphic_color=”#ffffff” graphic_bg_color=”#b1005d” align_h=”left” align_v=”top” side_graphic_spacing=”20px” max_width=”none” child=”true” connector_width=”1px” connector_style=”dashed” connector_color=”#272727″ graphic_icon=”share-alt”][x_feature_box title=”Update 30/10/2017″ title_color=”” text=”The NINJA-Pilot RCT has been published in the BJS. Click to download: http://onlinelibrary.wiley.com/doi/10.1002/bjs5.13/epdf” text_color=”” graphic=”icon” graphic_size=”30px” graphic_shape=”circle” graphic_color=”#ffffff” graphic_bg_color=”#b1005d” align_h=”left” align_v=”top” side_graphic_spacing=”20px” max_width=”none” child=”true” connector_width=”1px” connector_style=”dashed” connector_color=”#272727″ graphic_icon=”institution”][x_feature_box title=”Update 19/07/2017″ title_color=”” text=”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.” text_color=”” graphic=”icon” graphic_size=”30px” graphic_shape=”circle” graphic_color=”#ffffff” graphic_bg_color=”#b1005d” align_h=”left” align_v=”top” side_graphic_spacing=”20px” max_width=”none” child=”true” connector_width=”1px” connector_style=”dashed” connector_color=”#272727″ graphic_icon=”share-alt”][x_feature_box title=”Update 07/04/2017″ title_color=”” text=”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.” text_color=”” graphic=”icon” graphic_size=”30px” graphic_shape=”circle” graphic_color=”#ffffff” graphic_bg_color=”#b1005d” align_h=”left” align_v=”top” side_graphic_spacing=”20px” max_width=”none” child=”true” connector_width=”1px” connector_style=”dashed” connector_color=”#272727″ graphic_icon=”user-plus”][x_feature_box title=”Update 01/04/2016″ title_color=”” text=”The team have submitted a first stage application to the NIHR RfPB panel for funding for a full trial.” text_color=”” graphic=”icon” graphic_size=”30px” graphic_shape=”circle” graphic_color=”#ffffff” graphic_bg_color=”#b1005d” align_h=”left” align_v=”top” side_graphic_spacing=”20px” max_width=”none” child=”true” connector_width=”1px” connector_style=”dashed” connector_color=”#272727″ graphic_icon=”hand-o-right”][x_feature_box title=”Update 01/01/2016″ title_color=”” text=”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.” text_color=”” graphic=”icon” graphic_size=”30px” graphic_shape=”circle” graphic_color=”#ffffff” graphic_bg_color=”#b1005d” align_h=”left” align_v=”top” side_graphic_spacing=”20px” max_width=”none” child=”true” connector_width=”1px” connector_style=”dashed” connector_color=”#272727″ graphic_icon=”file-o”][/x_feature_list][x_custom_headline level=”h4″ looks_like=”h4″ accent=”false”]Register to become a NINJA centre[/x_custom_headline][x_text]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.[/x_text][/x_column][x_column bg_color=”” type=”1/3″ style=”padding: 0px 0px 0px 0px; “][x_image type=”none” src=”https://reconstructivesurgerytrials.net/wp-content/uploads/2015/06/NINJA-Slider-3.png” alt=”” link=”false” href=”#” title=”” target=”” info=”none” info_place=”top” info_trigger=”hover” info_content=””][x_accordion][x_accordion_item title=”Status” open=”true”][icon_list] [icon_list_item type=”check-square-o”]Protocol development [/icon_list_item] [icon_list_item type=”check-square-o”]Audit published [/icon_list_item][icon_list_item type=”check-square-o”]NRES approval [/icon_list_item][icon_list_item type=”check-square-o”]Pilot RCT Protocol published [/icon_list_item][icon_list_item type=”check-square-o”]Pilot RCT Data collection [/icon_list_item] [icon_list_item type=”check-square-o”]Manuscript submission [/icon_list_item][icon_list_item type=”check-square-o”]Publication [/icon_list_item][icon_list_item type=”check-square-o”]Definitive RCT funding [/icon_list_item][icon_list_item type=”square”]NINJA RCT site set up[/icon_list_item][icon_list_item type=”square”]NINJA RCT patient recruitment[/icon_list_item][icon_list_item type=”square-o”]NINJA RCT data analysis[/icon_list_item][icon_list_item type=”square-o”]NINJA RCT publication [/icon_list_item][/icon_list][/x_accordion_item][x_accordion_item title=”Steering group” open=”false”]Abhilash Jain
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[/x_accordion_item][x_accordion_item title=”Collaborators” open=”false”]

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.

 [/x_accordion_item][x_accordion_item title=”Trials Unit” open=”false”]Surgical Intervention Trials Unit (SITU)
University of Oxford[/x_accordion_item][x_accordion_item title=”Funding” open=”false”]NIHR RfPB £348,637
BSSH £27,000[/x_accordion_item][x_accordion_item title=”Outputs” open=”false”]Presentations

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[/x_accordion_item][x_accordion_item title=”Downloads” open=”false”]NINJA Pilot RCT results paper[/x_accordion_item][x_accordion_item title=”Contact” open=”true”]We are now recruiting units for the definitive trial. https://ninja.octru.ox.ac.uk/contact-us-14 or
ninja@ndorms.ox.ac.uk[/x_accordion_item][/x_accordion][/x_column][/x_row][/x_section]