The NINJA Trial - should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multi-centre randomised control trial
<p><strong>Introduction:</strong> Trauma to the nail bed is the most common surgically treated paediatric hand injury. The majority of surgeons replace the nail plate after repairing the nail bed despite a lack of evidence to do so. Replacing the nail plate may be associated with i...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Journal article |
| Published: |
BMJ Publishing
2019
|
| _version_ | 1826288404108673024 |
|---|---|
| author | Jain, A Jones, A Gardiner, M Cooper, C Sierakowski, A Dritsaki, M Png, M Stokes, J Shirkey, B Cook, J Beard, D Greig, A |
| author_facet | Jain, A Jones, A Gardiner, M Cooper, C Sierakowski, A Dritsaki, M Png, M Stokes, J Shirkey, B Cook, J Beard, D Greig, A |
| author_sort | Jain, A |
| collection | OXFORD |
| description | <p><strong>Introduction:</strong> Trauma to the nail bed is the most common surgically treated paediatric hand injury. The majority of surgeons replace the nail plate after repairing the nail bed despite a lack of evidence to do so. Replacing the nail plate may be associated with increased postoperative infection. We will investigate the impact of replacing or discarding the nail plate on infection, cosmetic appearance, pain and subsequent healthcare use. The Nail bed INJury Analysis trial (NINJA) aims to answer the question of whether the nail plate should be replaced or discarded after surgical nail bed repair in children.</p> <p><strong>Methods and analysis:</strong> A two-arm parallel group open multicentre randomised control trial of replacing the nail plate or not, as part of a nail bed repair, will be undertaken in children presenting within 48 hours of a nail bed injury requiring surgical repair. The coprimary outcomes are: cosmetic appearance summary score at a minimum of 4 months and surgical site infection at around 7 days following surgery. Secondary outcomes are EuroQol EQ-5D-(Y); the pain intensity experienced at first dressing change; child/parent satisfaction with nail healing and healthcare resource use. We will recruit a minimum of 416 patients (208 in each group) over 3 years. Children and their parents/carers will be reviewed in clinic around 7 days after their operation and will be assessed for surgical site infection or other problems. The children, or depending on age, their parents/carers, will also be asked to complete a questionnaire and send in photos of their fingernail at a minimum of 4 months postsurgery to assess cosmetic appearance.</p> <p><strong>Ethics and dissemination:</strong> The South Central Research Ethics Committee approved this study on 4 June 2019 (18/SC/0024). A manuscript to a peer-reviewed journal will be submitted on completion of the trial as per National Institute for Health Research publication policy. The results of this trial will substantially inform clinical practice and provide evidence on whether the practice of replacing the nail plate should continue at the time of nail bed repair.</p> |
| first_indexed | 2024-03-07T02:13:12Z |
| format | Journal article |
| id | oxford-uuid:a1567bdb-4fc4-4970-918a-09d9fcecf3a4 |
| institution | University of Oxford |
| last_indexed | 2024-03-07T02:13:12Z |
| publishDate | 2019 |
| publisher | BMJ Publishing |
| record_format | dspace |
| spelling | oxford-uuid:a1567bdb-4fc4-4970-918a-09d9fcecf3a42022-03-27T02:12:36ZThe NINJA Trial - should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multi-centre randomised control trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:a1567bdb-4fc4-4970-918a-09d9fcecf3a4Symplectic Elements at OxfordBMJ Publishing2019Jain, AJones, AGardiner, MCooper, CSierakowski, ADritsaki, MPng, MStokes, JShirkey, BCook, JBeard, DGreig, A<p><strong>Introduction:</strong> Trauma to the nail bed is the most common surgically treated paediatric hand injury. The majority of surgeons replace the nail plate after repairing the nail bed despite a lack of evidence to do so. Replacing the nail plate may be associated with increased postoperative infection. We will investigate the impact of replacing or discarding the nail plate on infection, cosmetic appearance, pain and subsequent healthcare use. The Nail bed INJury Analysis trial (NINJA) aims to answer the question of whether the nail plate should be replaced or discarded after surgical nail bed repair in children.</p> <p><strong>Methods and analysis:</strong> A two-arm parallel group open multicentre randomised control trial of replacing the nail plate or not, as part of a nail bed repair, will be undertaken in children presenting within 48 hours of a nail bed injury requiring surgical repair. The coprimary outcomes are: cosmetic appearance summary score at a minimum of 4 months and surgical site infection at around 7 days following surgery. Secondary outcomes are EuroQol EQ-5D-(Y); the pain intensity experienced at first dressing change; child/parent satisfaction with nail healing and healthcare resource use. We will recruit a minimum of 416 patients (208 in each group) over 3 years. Children and their parents/carers will be reviewed in clinic around 7 days after their operation and will be assessed for surgical site infection or other problems. The children, or depending on age, their parents/carers, will also be asked to complete a questionnaire and send in photos of their fingernail at a minimum of 4 months postsurgery to assess cosmetic appearance.</p> <p><strong>Ethics and dissemination:</strong> The South Central Research Ethics Committee approved this study on 4 June 2019 (18/SC/0024). A manuscript to a peer-reviewed journal will be submitted on completion of the trial as per National Institute for Health Research publication policy. The results of this trial will substantially inform clinical practice and provide evidence on whether the practice of replacing the nail plate should continue at the time of nail bed repair.</p> |
| spellingShingle | Jain, A Jones, A Gardiner, M Cooper, C Sierakowski, A Dritsaki, M Png, M Stokes, J Shirkey, B Cook, J Beard, D Greig, A The NINJA Trial - should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multi-centre randomised control trial |
| title | The NINJA Trial - should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multi-centre randomised control trial |
| title_full | The NINJA Trial - should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multi-centre randomised control trial |
| title_fullStr | The NINJA Trial - should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multi-centre randomised control trial |
| title_full_unstemmed | The NINJA Trial - should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multi-centre randomised control trial |
| title_short | The NINJA Trial - should the nail plate be replaced or discarded after nail bed repair in children? Protocol for a multi-centre randomised control trial |
| title_sort | ninja trial should the nail plate be replaced or discarded after nail bed repair in children protocol for a multi centre randomised control trial |
| work_keys_str_mv | AT jaina theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT jonesa theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT gardinerm theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT cooperc theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT sierakowskia theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT dritsakim theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT pngm theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT stokesj theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT shirkeyb theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT cookj theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT beardd theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT greiga theninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT jaina ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT jonesa ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT gardinerm ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT cooperc ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT sierakowskia ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT dritsakim ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT pngm ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT stokesj ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT shirkeyb ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT cookj ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT beardd ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial AT greiga ninjatrialshouldthenailplatebereplacedordiscardedafternailbedrepairinchildrenprotocolforamulticentrerandomisedcontroltrial |