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Nail bed INJury Analysis (NINJA-P)

Nail bed INJury Analysis (NINJA) Pilot study: should the nail plate be replaced or discarded after nail bed repair in children?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16571591
Enrollment
60
Registered
2015-05-21
Start date
2015-04-21
Completion date
Unknown
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury to the nail bed in children which requires surgery Injury, Occupational Diseases, Poisoning Nail bed injury

Interventions

Replace or discard nail plate after nail bed injury.

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age <16 years 2. Acute nail bed injury (occurring within 48 hours of presentation at trial centre) requiring surgical repair. 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

Exclusion criteria

Exclusion criteria: 1. Patients aged >16 years 2. Patients who present with an already infected nail bed injury 3. Patients with underlying nail disease or deformity prior to the injury 4. Patients with an associated distal phalanx fracture requiring fixation with a Kirschner wire. This is considered to be another potential source of infection and therefore a confounding variable 5. Patients with complete amputation of the distal fingertip including all or part of the nail bed, which requires repair as a composite graft or replantation 6. Patients with loss of part or all of the nail bed requiring a nail bed graft or flap reconstruction

Design outcomes

Primary

MeasureTime frame
Complications measured at 2 weeks, 30 days and 4 months post intervention

Secondary

MeasureTime frame
1. Pain at dressing change measured at 2 week dressing change - before and during dressing change 2. Visual Analogue Score used 4 months post intervention 3. ZOOK classification measured at 4 months

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026