Condition category
Injury, Occupational Diseases, Poisoning
Date applied
20/05/2015
Date assigned
21/05/2015
Last edited
19/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Miss Nicola Farrar

ORCID ID

Contact details

University of Oxford
Nuffield Orthopaedic Centre
Windmill Road
Oxford
OX3 7LD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18516

Study information

Scientific title

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

Acronym

NINJA-P

Study hypothesis

Should the nail plate be replaced or discarded after nail bed repair in children?

Ethics approval

Ref: 15/LO/0067.

Study design

Randomised interventional study

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 below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

21/04/2015

Overall trial end date

15/09/2015

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

UK Sample Size: 60

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

United Kingdom

Trial participating centre

University of Oxford
Nuffield Orthopaedic Centre Windmill Road
Oxford
OX3 7LD
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Old Road
Headington
Oxford
OX3 7LF
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

British Society for Surgery of the Hand (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.pilotfeasibilitystudies.com/content/1/1/29

Publication citations

Additional files

Editorial Notes