Nail bed INJury Assessment Pilot (NINJA-P) randomised controlled trial of replacing or discarding the nail plate after nail bed repair in children

Background Nail bed injuries are the most common hand injury in children. Surgical dogma is to replace the nail plate after repairing the nail bed. Recent evidence suggests this might increase infection rates and returns to clinic. The aim of this pilot randomised control trial was to inform the design and conduct of a definitive trial comparing replacing or discarding the nail plate after nail bed repair. Methods This study recruited participants from four hand units in the United Kingdom from April to July 2015. Participants were children under the age of 16 years with a nail bed injury requiring surgery. They were randomised to either having the nail plate replaced or discarded after nail bed repair. Additionally, follow-up method was also randomly allocated (postal versus clinic). We collected information on complications at two weeks and 30 days, and on nail plate appearance at four months using the Zook classification. Two possible approaches to follow-up were also piloted and compared. Results During the recruitment period there were 156 potentially eligible children. Sixty were randomised using remote web-based allocation in just over 3 months. By two weeks, there were two infections, both in children with replaced nail plates. The nail replaced group also experienced more complications. There was no evidence of a difference in return rates between postal and clinic follow-up. Conclusions This is the first pilot randomised control trial delivered using the Reconstructive Surgery Trials Network. Recruitment was rapid and nail bed repair appeared to have low complication and infection rates. The study findings have led to revision of the definitive trial protocol including the mode and timing of follow-up and modification of the Zook classification