Nail bed injuries Injury, Occupational Diseases, Poisoning Other and unspecified injuries of wrist and hand
Conditions
Interventions
Participants will be assigned to nail-plate replaced or nail-plate discarded groups. A web-based randomisation system will be used and the allocations will be computer generated with a 1:1 ratio, and
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged below 16 years old at the time of presentation to the participating unit 2. Acute nail bed injury (occurring within 48 hours of presentation at trial centre) believed to require surgical repair by the admitting surgical team. This includes sharp lacerations, stellate lacerations, crush and avulsion injuries of the nail bed, injuries involving the sterile and/or germinal matrix, nail bed injuries with an associated pulp laceration and/or with an associated ‘tuft’ fracture of the distal phalanx 3. Patients whose parent or legal guardian consent to their inclusion in the trial and are willing to return for follow up (including submission of photos) 4. Sufficient understanding of the child and parent/guardian participant information sheets as deemed by recruiting team at local sites 5. Single digit nail bed injury
Exclusion criteria
Exclusion criteria: 1. Patients who present with an already infected nail bed injury 2. Patients with underlying nail disease or deformity in the injured or contralateral finger prior to the injury 3. Patients with an associated distal phalanx fracture requiring fixation with a Kirschner wire 4. Patients with complete amputation of the distal fingertip including all or part of the nail bed 5. Patients with loss of part or all of the nail bed, requiring a nail bed graft or flap reconstruction 6. Previous NINJA trial participant (assessed at baseline) 7. Multiple nail bed injuries
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure: 1. The cosmetic appearance of the fingernail as defined by the Oxford fingernail appearance score (OFNAS) at final follow-up (a minimum of four months up to 12 months post-randomisation) 2. The incidence of infection defined as per the centres for disease control criteria (CDC 1993) within 4 months Previous primary outcome measure: 1. The cosmetic appearance of the fingernail as defined by the modified Zook score at 4 months 2. The incidence of infection defined as per the centres for disease control criteria (CDC 1993) within 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life, measured by EuroQol EQ-5D-(Y), EuroQol EQ-5D-(Y) proxy and PedsQL completed by the child or parent/guardian according to the age of the participant at 7-10 days and 4 months 2. Level of pain experienced by the child at their first dressing change according to the child or judged by the parent/guardian (3 point Likert scale for children [modified Wong Baker scale]) at 7-10 days and 4 months 3. The cost effectiveness (including resource use) measured by healthcare resource utilisation reports from the parent/guardian (i.e. hospital visits, dressing and antibiotic use and in some cases hospital readmission and repeat surgery), measured at 7-10 days and 4 months 4. Chronic infection within the last 4 months, measured by participant reported incidence of infection with clinical notes confirmation at 7-10 days and 4 months 5. Participant or parent/guardian reported satisfaction with nail healing, measured by 3 point Likert scale for the children (if old enough) and a VAS score for the parents/guardians at 4 months | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed