Effectiveness of nail bed repair in children with or without replacing the fingernail: NINJA multicentre randomized clinical trial
Open Access
- 22 March 2023
- journal article
- research article
- Published by Oxford University Press (OUP) in British Journal of Surgery
- Vol. 110 (4) , 432-438
Abstract
Surgery for nail bed injuries in children is common. One of the key surgical decisions is whether to replace the nail plate following nail bed repair. The aim of this RCT was to assess the clinical effectiveness and cost-effectiveness of nail bed repair with fingernail replacement/substitution compared with repair without fingernail replacement. A two-arm 1 : 1 parallel-group open multicentre superiority RCT was performed across 20 secondary-care hospitals in the UK. The co-primary outcomes were surgical-site infection at around 7 days after surgery and cosmetic appearance summary score at a minimum of 4 months. Some 451 children presenting with a suspected nail bed injury were recruited between July 2018 and July 2019; 224 were allocated to the nail-discarded arm, and 227 to the nail-replaced arm. There was no difference in the number of surgical-site infections at around 7 days between the two interventions or in cosmetic appearance. The mean total healthcare cost over the 4 months after surgery was €84 (95 per cent c.i. 34 to 140) lower for the nail-discarded arm than the nail-replaced arm (P < 0.001). After nail bed repair, discarding the fingernail was associated with similar rates of infection and cosmesis ratings as replacement of the finger nail, but was cost saving. Registration number: ISRCTN44551796 (http://www.controlled-trials.com).Keywords
Funding Information
- National Institute for Health Research
- NIHR Oxford Biomedical Research Centre
- NIHR
- NIHR
- Royal College of Surgeons of England
- Rosetrees Trust
- University of Oxford
This publication has 10 references indexed in Scilit:
- The Oxford Finger Nail Appearance Score - a new scoring system for fingernail deformity following paediatric finger tip traumaJournal of Plastic, Reconstructive & Aesthetic Surgery, 2021
- Should the nail plate be replaced or discarded after nail bed repair in children? Nail bed INJury Analysis (NINJA) randomised controlled trial: a health economic and statistical analysis planTrials, 2020
- Management of Pediatric Distal Fingertip Injuries: A Systematic Literature ReviewPlastic and Reconstructive Surgery - Global Open, 2020
- NINJA trial: should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multicentre randomised control trialBMJ Open, 2019
- Randomized feasibility trial of replacing or discarding the nail plate after nail-bed repair in childrenBritish Journal of Surgery, 2017
- Surgical treatment of paediatric nail bed injuries in the United Kingdom: Surgeon and patient priorities for future researchJournal of Plastic, Reconstructive & Aesthetic Surgery, 2016
- Interventions for treating fingertip entrapment injuries in childrenCochrane Database of Systematic Reviews, 2014
- Pediatric Nailbed Repair StudyPlastic and Reconstructive Surgery, 2012
- Children Treated in United States Emergency Departments for Door-Related Injuries, 1999-2008Clinical Pediatrics, 2011
- Pediatric surgical site and soft tissue infectionsPediatric Critical Care Medicine, 2005