Title: Nail Injury Analysis Trial
Funder: Department of Health and Social Care

Abstract: Background Trauma to the nail bed is the commonest surgically treated paediatric hand injury in the UK (10,000/yr). The majority of NHS surgeons replace the nail plate after repairing the nail bed despite evidence to do so. Replacing the nail may be associated with increased post-operative infection. We will look at impact of replacing or discarding the nail on cosmetic appearance, infection, pain, and subsequent healthcare use. Research Question Should the nail plate be replaced or discarded after nail bed repair in children? Methods Study design: Two-arm parallel group open multicentre randomised trial of replacing or not the nail as part of a nail bed repair Population: Children presenting within 48 hours of a nail bed injury requiring surgical repair Interventions: Eligible patients will be randomised to receive one of two possible management options post nail bed repair surgery. They will either have the nail plate replaced or not after nail bed repair. Following adequate debridement and washout, the nail bed repair will be completed using interrupted 6/0 or 7/0 sutures. In the nail replace group, the nail plate will be secured using a figure-of-eight Vicryl Rapide&trade; suture, orientated in the longitudinal axis. If the nail plate is damaged such that it can not be replaced, a subsitute will be used . Co-Primary Outcomes: Comesis appearance summary score (scored according to a modified Zook classification system) and Surgical site infection Secondary outcomes:: EuroQol EQ-5D-(Y) (baseline, 7-10 days and 4 months) completed by the child/parent or carer according to the age of the participant The level of pain experienced by the child at their first dressing change (7-10 days) Child/Parent satisfaction with nail healing (3 point Likert scale for the children and a VAS score for the parents at 4 months) Healthcare resource utilisation (7-10 days and 4 months) Chronic infection at 4 months Randomisation: 1:1 allocation stratified by site and formed of random permuted blocks of varying size. Sample size: We plan to recruit a total of 416 patients (208 in each group) in order to 90% power patients from for the comparisons of the co-primary outcomes. Statistical analysis: A two sided 5% significance level will be adopted with associated 95% confidence intervals (CIs) whenever possible using appropriate summary measures (e.g.number of events and percentage for binary measures). Follow-up: Children in this study and their parents/carers will be asked to return to the clinic 7-10 days after their operation to repair the nail bed injury. Doctors and nurses will then assess the area to look for infection or other problems. The children and their parents/carers will also be asked to complete a questionnaire and send in photos of their fingernail at 3 months, so that we can assess how the repaired nail is growing. Study duration: The study will run for 3 years and will be managed by a team of expert surgeons and researchers who have a strong track record of delivering research in this area and of this kind.

Lay abstract: The nail bed is the soft area beneath the hard fingernail. Injuries to it are the commonest hand injury in children. They are typically caused by the child crushing their fingers in a door. Over 10,000 children undergo surgery to repair the cut in the nail bed in the UK every year. During surgery, the nail is taken off and the cut stitched up. The nail can either be put back on, or thrown away. Some doctors think that the replaced nail acts like a barrier against infection. Others think that it may cause them. Infections may mean the new nail grows abnormally, with a need for extra general practice and hospital visits. Work with parents and children tell us they value most the subsequent cosmetic appearance which could be also affected. We will assess the two options in a research study called a randomised controlled trial. It will enable a fair and reliable comparison of the two options. We will look at impact of the two options on cosmetic appearance, occurrence of an infection, pain, and subsequent healthcare use. Children in this study and their parents/carers will be asked to return to the clinic around 7 days later. Doctors and nurses will assess the nail and finger s health. The children and their parents/carers will also be asked to complete a questionnaire and send in photos of their fingernail after 4 months. We plan to recruit over 400 patients from around 30 NHS hospitals across the UK. The study will run for 3 years and will be managed by a team of expert surgeons and researchers who have a strong track record of delivering research in this area and of this kind. Results of the trial will be shared through scientific journals and conferences and social media.

Research activity codes: 6.4 SURGERY
Health categories: INJURIES AND ACCIDENTS