Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/04/2018
Date assigned
24/04/2018
Last edited
11/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Nail bed injuries are the most common hand injury in children in the UK. Treatment usually involves surgical repair of a laceration located underneath the fingernail. To do this the fingernail is removed, the laceration repaired, and the fingernail can be replaced or discarded. Historically the nail was replaced routinely but recent evidence indicates not replacing the nail may reduce the incidence of infection and complications after surgery. The aim of this study is to compare replacing the nail to the alternative practice of discarding (not replacing) the nail as part of the surgical nail bed repair for the treatment of nail bed injuries.

Who can participate?
Patients aged under 16 with a nail bed injury

What does the study involve?
Participants are randomly allocated to have their nail plate replaced or discarded. The cosmetic appearance of the fingernail and the incidence of infection are assessed after 4 months.

What are the possible benefits and risks of participating?
It cannot be guaranteed that a child will get any direct benefit from taking part in this study. However, participating may lead to better care and outcomes after surgery in patients with nail bed injuries in the future. The surgery that a child will receive is the same whether they take part in the study or not. Parents/guardians will be asked to complete some short questionnaires (15-20 minutes) and submit a photograph in addition to any clinical treatment their child receives.

Where is the study run from?
Evelina London Children’s Hospital (UK) and 19 other sites in the UK.

When is the study starting and how long is it expected to run for?
August 2018 (updated 12/07/2019, previously: September 2017) to April 2020.

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Amy Jones
ninja@ndorms.ox.ac.uk

Trial website

https://ninja.octru.ox.ac.uk/

Contact information

Type

Scientific

Primary contact

Mrs Amy Jones

ORCID ID

Contact details

Surgical Intervention Trials Unit (SITU)
Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences
University of Oxford
Botnar Research Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
+44 (0)1865 227715
ninja@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35666

Study information

Scientific title

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

Acronym

NINJA

Study hypothesis

Nail bed injuries are the most common hand injury in children in the UK. Treatment usually involves surgical repair of a laceration located underneath the fingernail. To do this the fingernail is removed, the laceration repaired, and the fingernail can be replaced or discarded. Historically the nail was replaced routinely but recent evidence indicates not replacing the nail may reduce the incidence of infection and post operative complications. The NINJA trial is a multicentre, parallel group, randomised controlled trial comparing replacing the nail to the alternative practice of discarding (not-replacing) the nail as part of the surgical nail bed repair for the treatment of nail bed injuries. This study will be undertaken at multiple UK sites, identified through the Reconstructive Surgery Trials Network (RSTN) over a 3 year period. Each patient will be followed up for 4 months.

Ethics approval

South Central: Berkshire-B, 20/02/2018, ref: 18/SC/0024

Study design

Randomised; Both; Design type: Treatment, Surgery, Validation of outcome measures

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Nail bed injuries

Intervention

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 stratified by site using random permuted blocks of varying size within stratum.

Despite their frequency, controversy remains around the appropriate treatment of nail bed injuries. Without proper treatment, injury to the nail complex has the potential to cause considerable dysfunction and/or deformity. The long-accepted teaching has been to remove the nail plate (i.e. the fingernail), repair the underlying nail bed laceration with fine absorbable sutures and replace the nail under the eponychium (i.e. nail fold). The replaced nail has no capacity for re-growth. Instead, as a new nail begins to grow, the replaced nail is gradually pushed out until it becomes loose. The rationale for replacing the nail is that it both protects the nail bed repair and acts as a ‘splint’ by holding open the nail fold and preventing scarring between the nail fold and the nail bed (synechiae). However, there is no evidence that replacing the nail has better results than not replacing it. The Nail bed INJury Assessment (NINJA) trial seeks to answer the question “should the nail plate be replaced or discarded after nail bed repair in children, as evaluated by overall complications and appearance of the nail?

Participants will be followed up for a total of 4 months after randomisation.

Intervention type

Procedure/Surgery

Phase

Drug names

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 outcome measures

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

Overall trial start date

01/09/2017

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 416; UK Sample Size: 416

Total final enrolment

451

Participant 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

Recruitment start date

06/07/2018

Recruitment end date

01/07/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Evelina London Children’s Hospital (lead centre)
Westminster Bridge Road Lambeth
London
SE1 7EH
United Kingdom

Trial participating centre

Broomfield Hospital
Court Road Broomfield
Chelmsford
CM1 7ET
United Kingdom

Trial participating centre

Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Chelsea and Westminster Hospital
369 Fulham Rd Chelsea
London
SW10 9NH
United Kingdom

Trial participating centre

Leeds General Infirmary
Great George St
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom

Trial participating centre

Peterborough City Hospital
Edith Cavell Campus Bretton Gate
Peterborough
PE3 9GZ
United Kingdom

Trial participating centre

Queen Victoria Hospital
Holtye Rd
East Grinstead
RH19 3DZ
United Kingdom

Trial participating centre

Royal Cornwall Hospital
Truro
TR1 3LQ
United Kingdom

Trial participating centre

Royal Derby Hospital
Derby
DE22 3NE
United Kingdom

Trial participating centre

Royal Hospital for Sick Children
9 Sciennes Road
Edinburgh
EH9 1LF
United Kingdom

Trial participating centre

Royal Manchester Children’s Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Salisbury District Hospital
Salisbury
SP2 8BJ
United Kingdom

Trial participating centre

St George's Hospital
Blackshaw Rd
London
SW17 0QT
United Kingdom

Trial participating centre

Stoke Mandeville Hospital
Mandeville Road
Aylesbury
HP21 8AL
United Kingdom

Trial participating centre

The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

The Ulster Hospital
Upper Newtownards Road Dundonald
Belfast
BT16 1RH
United Kingdom

Trial participating centre

University Hospital of Wales
Heath Park Way
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Wexham Park Hospital
Slough
SL2 4HL
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

The Chancellor Masters and Scholars of the University Of Oxford
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 (2)89885
karl.shepherd@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-1215-20041

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Protocol will be available once published, other documents will be available on request. Planned publication of the study results in a high-impact peer reviewed journal in 2021.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/04/2021

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/05/2020: The following changes have been made: 1. The recruitment end date has been changed from 01/12/2019 to 01/07/2019. 2. The overall trial end date has been changed from 01/04/2020 to 30/06/2020. 3. The total final enrolment number has been added. 12/07/2019: The following changes were made to the trial record: 1. The target number of participants was changed from Planned Sample Size: 464; UK Sample Size: 464 to Planned Sample Size: 416; UK Sample Size: 416. 2. The recruitment start date was changed from 01/05/2018 to 06/07/2018. 3. The recruitment end date was changed from 01/12/2019 to 01/12/2019. 4. 16 trial participating centres were added. 25/03/2019: The condition was updated from "Specialty: Injuries and Emergencies, Primary sub-specialty: Pre-hospital and Emergency Department Care; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the wrist and hand" to "Nail bed injuries".