Results
surgical-site infection, ’ fingernails, vomiting, pain, infection
ADVERSE EVENTS, INFECTION, SECONDARY, ADVERSE EVENT, PARONYCHIA
Some 451 patients were recruited between July 2018 and December 2019; 224 patients were allocated to the nail-discarded arm and 227 to the nail-replaced arm (Baseline characteristics of participants according to intervention groupValues are Compliance with treatment allocated at randomizationValues are The type of anaesthetic used was similar in each group, as were perioperative antibiotics (Two serious adverse events were recorded. The first patient developed paronychia (infection around the nail plate) approximately 4 months after surgery, requiring readmission to hospital and removal of a nail spicule. This was an expected adverse event and determined to be related to the surgical intervention. The second patient suffered a reaction to general anaesthetic causing vomiting and intolerance to anything orally, leading to a 1-week stay in hospital for hydration. This was an unexpected adverse event and was deemed unlikely to be related to the surgical intervention.For the co-primary outcome SSI, 440 patients had data available for the primary analysis (97.6 per cent of those randomized; 218 in discarded arm, 222 in replaced arm) (Analysis of surgical-site infection at around 7 daysValues are Assessors and parents scored patients’ fingernails using the OFNAS for the cosmetic co-primary outcome (Main, secondary, and subgroup analyses of Oxford Finger Nail Appearance Score cosmetic outcome*Values in parentheses are 95% confidence intervals; effect sizes are shown as ORs, except †probability that Oxford Finger Nail Appearance Score There was no significant difference in cosmetic appearance between groups in the co-primary outcome of cosmetic appearance, as measured by the OFNAS (The adjusted secondary analysis did not identify any statistically significant difference in OFNAS values between the two treatment groups (OR 0.70, 95 per cent c.i. 0.43 to 1.12; The assessor scores did not indicate a difference between the nail-replaced and nail- discarded groups. However, the scores given by the parents suggested that there was a statistically significant difference in favour of the nail-discarded group. The treatment by subgroup interaction term was statistically significant (OR 0.24, 95 per cent c.i.: 0.06, 0.96. Preoperative antibiotic use did not affect the difference in cosmetic appearance between the two treatment groups as measured by the OFNAS (There were no statistical differences between groups for the secondary outcomes, including pain at dressing change, late incidence of SSI (up to 12 months), parent/child satisfaction with nail appearance, and EQ-5D-Y™ index scores (