Nail bed INJury Analysis (NINJA)
| ISRCTN | ISRCTN44551796 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44551796 |
| IRAS number | 219560 |
| Secondary identifying numbers | CPMS 35666 |
- Submission date
- 23/04/2018
- Registration date
- 24/04/2018
- Last edited
- 27/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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 years 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 is assessed at the final follow-up (a minimum of four months up to 12 months) and the incidence of infection is 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 to April 2020
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
SITU-NDORMS team
situ@ndorms.ox.ac.uk
Contact information
Scientific
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
| Phone | +44 (0)1865 227715 |
|---|---|
| situ@ndorms.ox.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Treatment, Surgery, Validation of outcome measures |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Nail bed INJury Analysis (NINJA): Should the nail plate be replaced or discarded after nail bed repair in children? |
| Study acronym | NINJA |
| Study objectives | 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(s) | South Central: Berkshire-B, 20/02/2018, ref: 18/SC/0024 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 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 study start date | 01/09/2017 |
| Completion date | 30/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 416; UK Sample Size: 416 |
| Total final enrolment | 451 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/07/2018 |
| Date of final enrolment | 01/07/2019 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Lambeth
London
SE1 7EH
United Kingdom
Broomfield
Chelmsford
CM1 7ET
United Kingdom
Hull
HU3 2JZ
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Chelsea
London
SW10 9NH
United Kingdom
Leeds
LS1 3EX
United Kingdom
Stevenage
SG1 4AB
United Kingdom
Bretton Gate
Peterborough
PE3 9GZ
United Kingdom
East Grinstead
RH19 3DZ
United Kingdom
TR1 3LQ
United Kingdom
DE22 3NE
United Kingdom
Edinburgh
EH9 1LF
United Kingdom
Manchester
M13 9WL
United Kingdom
SP2 8BJ
United Kingdom
London
SW17 0QT
United Kingdom
Aylesbury
HP21 8AL
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Dundonald
Belfast
BT16 1RH
United Kingdom
Cardiff
CF14 4XW
United Kingdom
SL2 4HL
United Kingdom
Sponsor information
University/education
The Chancellor Masters and Scholars of the University Of Oxford
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 (2)89885 |
|---|---|
| karl.shepherd@admin.ox.ac.uk | |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| 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 plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/12/2019 | 22/10/2020 | Yes | No |
| Statistical Analysis Plan | 07/10/2020 | 31/10/2022 | No | No | |
| Results article | 22/03/2023 | 23/03/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | cost-effectiveness | 11/08/2023 | 08/07/2024 | Yes | No |
Editorial Notes
27/11/2024: IRAS number added, contact details updated.
08/07/2024: Publication reference added.
23/03/2023: Publication reference added.
22/12/2022: The primary outcome measure has been changed and the plain English summary updated accordingly.
31/10/2022: Publication reference added.
22/10/2020: Publication reference added.
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".
