Nail bed INJury Analysis (NINJA-P)
| ISRCTN | ISRCTN16571591 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16571591 |
| Secondary identifying numbers | 18516 |
- Submission date
- 20/05/2015
- Registration date
- 21/05/2015
- Last edited
- 21/11/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Accidental injuries to fingernails and the nail bed underneath are very common, especially among children. Injuries can arise as a result of various factors, such as having the fingers crushed while playing, or getting them caught in a closing door. Sometimes, surgery is required to repair the damage and reduce pain in the injured fingernail. Surgery can also reduce the likelihood of future nail deformity and risk of infection. Standard treatment for nail bed injuries involves removal of the damaged fingernail (which may already be partially detached) and repair of the nail bed using dissolvable stitches. Following this treatment, the surgeon can either replace the old nail before applying the dressings, or discard the nail and apply dressings straight onto the nail bed. Both techniques encourage the new nail to grow as normally as possible, but it is not known if one of these techniques works better than the other. This study seeks to answer the question: should the nail be replaced or discarded after nail bed repair in children? This study also aims to assess how feasible it would be to carry out a larger study within the NHS.
Who can participate?
Children under 16 with nail bed injury acquired within the previous 48 hours.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) have their nail replaced following treatment to repair the nail bed. Those in group 2 (intervention group) have their nail discarded following treatment to repair the nail bed. Follow up assessments are carried out to determine post-operative complications, appearance of the nail and patient pain levels.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
April 2015 to September 2015
Who is funding the study?
British Society for Surgery of the Hand (UK)
Who is the main contact?
Miss N Farrar
Contact information
Scientific
University of Oxford
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
Study information
| Study design | Randomised interventional study |
|---|---|
| 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 below to request a patient information sheet |
| Scientific title | Nail bed INJury Analysis (NINJA) Pilot study: should the nail plate be replaced or discarded after nail bed repair in children? |
| Study acronym | NINJA-P |
| Study hypothesis | Should the nail plate be replaced or discarded after nail bed repair in children? |
| Ethics approval(s) | Ref: 15/LO/0067 |
| Condition | Injury to the nail bed in children which requires surgery |
| Intervention | Replace or discard nail plate after nail bed injury. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Complications measured at 2 weeks, 30 days and 4 months post intervention |
| Secondary outcome measures | 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 |
| Overall study start date | 21/04/2015 |
| Overall study end date | 15/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 60 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 21/04/2015 |
| Recruitment end date | 15/09/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Windmill Road
Oxford
OX3 7LD
United Kingdom
Sponsor information
Hospital/treatment centre
Old Road
Headington
Oxford
OX3 7LF
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/08/2015 | Yes | No | |
| Results article | results | 01/11/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/11/2018: Publication reference added.
