BACKGROUND
The nail bed is the soft area beneath the hard fingernail. Injuries to it are the commonest hand injury in children. They are typically caused by the child crushing their fingers in a door.
Over 10,000 children undergo surgery to repair the cut in the nail bed in the UK every year. During surgery, the nail is taken off and the cut stitched up. The nail can either be put back on, or thrown away.
Some doctors think that the replaced nail acts like a barrier against infection. Others think that it may cause them. Infections may mean the new nail grows abnormally, with a need for extra general practice and hospital visits. Work with parents and children tell us they value most the subsequent cosmetic appearance which could be also affected.
STUDY DESIGN
We will assess the two options in a research study called NINJA, which is a randomised controlled trial. It will enable a fair and reliable comparison of the two options. We will look at impact of the two options on cosmetic appearance, occurrence of an infection, pain, and subsequent healthcare use.
NINJA is a multicentre, pragmatic randomised controlled trial, and the largest paediatric plastic surgery trial in the UK. Patients will be recruited from up to 30 centres across the United Kingdom over a period of 20 months. Participants will be randomised to either have the fingernail replaced or discarded following repair of the nailbed injury.
They will be followed up for 4 months at routine clinic appointments (typically between 7-10 days post operation) and via postal and electronic participant reported questionnaires at 4 months. The trial will run for 3 years.
Trial Publications
The main study paper can be found here.
The health economics paper can be found here.
The study protocol publication can be found here.
A methodological paper for the study can be found here.
The statistical analysis/health economics analysis plan publication can be found here.