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Associate Professor Abhilash Jain: “This is the first Plastic and Hand Surgery trial to be run by the Reconstructive Surgery Trials Network, which was recently set up to deliver clinical research for both the association of Plastic Surgery (BAPRAS) and the association of Hand Surgery (BSSH). This represents a small but significant step forward for reconstructive surgery within the UK.”
The NINJA study is a pilot study which will assess whether a study that looks at whether nail plates should be discarded or replaced after nail bed injury in children is feasible in the NHS.
Nail bed INJury Analysis (NINJA) Pilot Study:
Should the nail plate be replaced or discarded after nail bed repair in children?
The NINJA Pilot Study (funded by the British Society for Surgery of the Hand, BSSH) is a pragmatic multicentre study to assess whether the nail should be replaced or discarded after nail bed repair in children. The pilot will inform the design and conduct of a larger NINJA study with regards to recruitment, data collection and outcome measurement. The Surgical Intervention Trials Unit (SITU) at the University of Oxford, will co-ordinate the trial. This is the first plastic surgery trial of its kind and will form part of a developing research portfolio for the plastic surgery community.
Nail bed injuries are common and account for the majority of paediatric hand trauma cases treated by hand surgery units. The typical patient is a toddler who has caught their finger in a closing door. A single tertiary referral hand surgery unit will on average treat two to three patients with nail bed injuries per day.
Despite their frequency, controversy remains around the best treatment of nail bed injuries. Without proper treatment, injury to the nail complex has the potential to cause considerable dysfunction and/or deformity. The long-accepted surgery to repair the nail bed involves removing the fingernail (which is often broken or partially detached already) and carefully repairing the nail bed underneath using tiny dissolving stitches. This is important to help the new nail to grow out smoothly and look as normal as possible in the future. After repairing the nail bed, the surgeon can do one of two things:
- Replace the old nail before applying dressings
- Discard the nail and apply dressings straight onto the nail bed.
In both techniques, a new fingernail grows out from the base of the nail bed over a few months. The old nail cannot grow again after it has been removed and it is eventually pushed off by a new nail growing underneath it. Both of these techniques are routinely done by surgeons in the NHS, but we don’t know which one is best.
The rationale for replacing the nail is that it both protects the nail bed repair and acts as a ‘splint’ by holding open the nail fold and preventing scarring between the nail fold and the nail bed (synechiae).
However, there is no evidence that replacing the nail has better results than not replacing it and there is a suggestion that it may be associated with a small risk of infection.
Therefore the aim of a large NINJA study will be to find out if there is any difference between the two techniques
The objectives of the NINJA Pilot Study are to:
- Assess and monitor recruitment of patients to a study of this nature
- Identify any conflict or areas of concern with conducting research with this patient population and with the Plastic Surgery network
- Evaluate the recruitment process
- Test assessment tools to be used
- Monitor patient compliance with follow up procedures
- Gather information to develop the larger study and to calculate how many patients will be required for this
Randomisation will occur in the anaesthetic room via an internet portal. Follow up is at 2 weeks, 30 days and 4 months post randomisation.
May 2014 BSSH Award
December 2014 Protocol finalised and Ethics submission
January 2015 Ethics approval
March 2015 Site set-up
April 2015 Patient recruitment (first patient recruited on 21st April 2015)
June 2015 Main trial funding application
July 2015 Last patient recruited
November 2015 Pilot Follow up complete
The NINJA Team
Abhilash Jain, University of Oxford, Co-Chief Investigator
Aina Greig - Guy’s and St Thomas’ Hospitals NHS Trust, Co-Chief Investigator and PI at Lead Site
Dominic Furniss, Oxford University Hospitals NHS Trust, Principal Investigator
Claire Zweifel, Mid Essex Hospitals NHS Trust, Principal Investigator
Richard Pinder, Hull and East Yorkshire Hospitals NHS Trust, Principal Investigator
David Beard, Oxford SITU, Professor of Musculoskeletal Sciences
Jonathan Cook, Centre for Statistics in Medicine, Oxford SITU, Associate Professor of Statistics
Matthew Gardiner, Trainee Lead, Reconstructive Surgery Trials Network
Adam Sierakowski, Trainee Lead, NINJA Study Group
Cushla Cooper, Oxford SITU, Research Portfolio Manager
Nicola Farrar, Oxford SITU, Clinical Trials Administrator