Table 1

Objectives and outcome measures

ObjectivesOutcome measuresTime point(s) of evaluation of this outcome measure (if applicable)
Primary o bjectives
To assess the effects of replacing or discarding the fingernail by comparing the risk of infection and cosmetic appearance.
Incidence of surgical site infection (clinical assessment around 7 days and participant or parent/guardian reported with clinical notes at a minimum of 4 months if information is relevant to earlier time period).7 days
Oxford Finger Nail Appearance Score assessing nail appearance at a minimum of 4 months, considering five domains (shape, adherence, eponychium, surface quality and presence of split).At a minimum of 4 months
Secondary o bjectives
To assess whether there is a difference in participant/parent and guardian reported health-related quality of life according to whether the nail is replaced or discarded.
EuroQol EQ-5D-Y and proxy completed by the child/parent or guardian according to the age of the participant.Baseline, 7 days and a minimum of 4 months
To assess whether there is a difference in participant or parent/guardian-reported pain experienced between replacing and discarding the nail.The level of pain experienced by the child at their first dressing change assessed by the child or parent/guardian (3-point Likert scale for children).7 days
To conduct a parallel within-trial economic analysis to assess the cost-effectiveness (including resource use) of replacing versus discarding the nail.Healthcare resource use such as increased hospital visits, dressing and antibiotic use and in some cases hospital readmission and repeat surgery.7 days and 4 months
To assess if any surgical site infection has occurred within the 4 months since surgery.Participant or parent/guardian-reported incidence of infection with clinical notes confirmation.At a minimum of 4 months
To assess participant/parent satisfaction with nail healingChild or parent/guardian satisfaction with nail healing (3-point Likert scale for the children and a VAS score for the parents/guardians).At a minimum of 4 months
  • VAS, Visual Analogue Scale.