Effectiveness of nail bed repair in children with or without replacing the fingernail: NINJA multicentre randomized clinical trial.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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).

Cost Comparison of Kirschner Wire Versus Intramedullary Screw Fixation of Metacarpal and Phalangeal Fractures.

BACKGROUND: Intramedullary screw fixation is a relatively new technique for fixation of metacarpal and phalangeal fractures. The objective of this study was to compare health care-associated costs and outcomes for intramedullary screw versus Kirschner wire (K-wire) fixation of hand fractures. METHODS: A retrospective review of patients undergoing intramedullary screw fixation of hand fractures at a single center during 2016-2019 inclusive was conducted. Health care-associated costs were compared with age-matched and fracture pattern-matched controls who underwent K-wire fixation. RESULTS: Fifty patients met the study inclusion criteria, incorporating 62 fractures (29 K-wire, 33 intramedullary screw fixation). The median age was 34.6 years (18.0-90.1 years). There was no significant difference in primary operative costs (£1130.4 ± £162.7 for K-wire vs £1087.0 ± £104.2 for intramedullary screw), outpatient follow-up costs (£958.7 ± £149.4 for K-wire vs £782.4 ± £143.8 for intramedullary screw), or total health care-associated costs (£2089.1 ± £209.0 for K-wire vs £1869.4 ± £195.3 for intramedullary screw). However, follow-up costs were significantly lower for the uncomplicated intramedullary screw cohort (£847.1 ± £109.1 for K-wire vs £657.5 ± £130.8 for intramedullary screw, P = .05). Subgroup analysis also revealed that overall costs were significantly higher for buried K-wire techniques. Complication rates, time to return to active work, and Disabilities of the Arm, Shoulder, and Hand scores were similar. CONCLUSIONS: This study identified significantly lower outpatient follow-up costs for uncomplicated intramedullary screw fixation of hand fractures compared with K-wires, along with a trend toward lower overall health care-associated costs. In addition, buried K-wire techniques were also found to carry a significantly higher financial burden. Higher powered prospective studies are required to determine indirect costs.

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 controlled trial.

BACKGROUND: Nail 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/DESIGN: NINJA-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. DISCUSSION: The 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 REGISTRATION: First participant randomised: 21/04/2015, UKCRN Portfolio ID: 18516, ISRCTN16571591.