Abstract
BackgroundNail bed injuries account for the majority of paediatric hand trauma cases. Despite their frequency, controversy remains regarding their treatment. The accepted teaching is to remove the fingernail, repair the underlying nail bed with fine sutures and replace the nail under the nail fold. A recent study by Miranda et al. (Plast Reconst Surg. 129(2):394e-396e, 2012) suggests that replacing the nail is associated with increased complications, in particular post-operative infection. Nail bed INJury Assessment Pilot (NINJA-P) is an external pilot study for a large pragmatic, multicentre, randomised, controlled study (NINJA) to assess whether the nail should be replaced or discarded after nail bed repair in children under the age of 16.Methods/designNINJA-P is a randomised pilot study. The participants are patients below 16 years of age who require surgical repair of the nail bed. Eligible patients will be randomised to receive one of two possible interventions. Group 1 will have the nail replaced after nail bed repair, and group 2 will have the nail discarded. The clinical outcome measures include the presence of post-operative complications at 2 weeks and 30 days, the cosmetic appearance of the nail at 4 months and the level of pain experienced by the child at their first dressings change at 2 weeks. In order to inform the design of the main NINJA trial, the following feasibility data will also be recorded: the number of potentially eligible children and the proportion which agree to take part in the study, the proportion of children who received the allocated treatment and reasons for any non-compliance and the proportion of participants with a valid response at each follow-up point. Neither the patient, family members nor treating physicians will be blinded. A replaced nail can take several weeks to fall off once a new nail has grown out. The cosmetic appearance of the nail at 4 months will be assessed by a blinded assessor.DiscussionThe NINJA-P pilot study will inform the design and execution of the NINJA trial, which will assess whether the nail should be replaced or discarded after nail bed repair in children under 16. It will provide randomised comparative evidence for the treatment of this common injury.Trial registrationFirst participant randomised: 21/04/2015, UKCRN Portfolio ID: 18516, ISRCTN16571591
Highlights
Nail bed injuries account for the majority of paediatric hand trauma cases
The Nail bed INJury Assessment Pilot (NINJA-P) pilot study will inform the design and execution of the NINJA trial, which will assess whether the nail should be replaced or discarded after nail bed repair in children under 16
It is common practice to replace the nail after repairing the nail bed, but this is not known to improve the outcome and may even be associated with increased post-operative complications including infection
Summary
Nail bed injuries are the most common paediatric hand injury, yet there is a limited evidence base to guide treatment. It will achieve this by resolving key uncertainties relating to the design of the main study, including the number of patients that present with nail bed injuries over a defined period of time, the proportion of children who agree to take part in the study, the proportion of children who go on to receive the allocated treatment, reasons for any non-compliance and the proportion of participants with a valid response at each follow-up point As this is a research community with limited previous involvement in clinical trials, NINJA-P will provide important practical evidence regarding the conduct of trials in this area. Authors’ information AJ is the Chief Investigator and Associate Professor of Plastic and Hand Surgery, University of Oxford and Imperial College Healthcare NHS Trust.
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