Comparing the Old with the New: Randomised controlled trial of three different treatments for mild to moderate impetigo in children

INTERVENTION: The intervention will be randomised between 3 possible interventions described below; children with 3 or less impetigo lesions will be enrolled and all lesions will be managed 1. Topical fusidic acid ointment 2% twice a day for 5 days ‐ Fusidic acid 2% ointment (15g tube supplied) with single occasion wound cleaning by a nurse and topical fusidic acid ointment applied to each lesion then covered with occlusive dressing. Ongoing twice daily ointment and dressings twice daily will be done by parent/carer with instructions supplied with no adherence monitoring other than verbal review with nurse on Day 2 and day 7 Intervention 2. Topical hydrogen peroxide 1% (10g tube) applied twice a day for 5 days. Initial wound cleaning by nurse and H2O2 cream applied to each lesion then covered with an occlusive dressing. The topical antiseptic and sufficient dressings will be supplied to the family along with instructions with no adherence monitoring other than verbal review with nurse on Day 2 and day 7 Intervention 3: Wound care: the wound will be cleansed, scab softened and removed where possible, then covered with an occlusive dressing. Sufficient dressings will be supplied to the family along with instructions to cleanse and reapply dressing twice a day for 5 days with no adherence monitoring other than verbal review with nurse on Day 2 and day 7. Assessment of lesions will be done ongoing at day 2 and day 7 after enrollment CONDITION: Impetigo PRIMARY OUTCOME: The primary outcome is treatment success as evaluated by review of digital images on day 0‐7. ; Independent reviewers (clinician including paediatrician x4, dermatologist x2) masked to treatment allocation will compare digital images of skin lesions from days 0 and 7. The order of the images when reviewed will be randomly assigned to ensure further blinding. Outcomes will be scored as success if they have healed or improved and failure if same or worse, or if the reviewer was unable to determine success or failure compared to day 0. Assessment criteria will be adapted from trial and methodology published by Bowen et al. Lancet ID 2014 Dec 13;384(9960):2132‐40. ; SECONDARY OUTCOME: Clinical success at Day 7 based on nurse assessment using clinical notes, lesion size, patient report and clinical nursing assessment Secondary outcome ; Number of treatment failures on both Day 2 and Day 7 ; This includes children assessed as needing change management of lesions such as escalation to oral antibiotics, visiting their general practitioner for concerns over the skin infection, or admission to hospital or medical review. ; ; . ; ; Secondary outcome microbiologic based on detection of skin pathogens at Day 0 and Day 7 and comparison of antibiograms of isolated S.aureus and S.pyogenes from skin swabs INCLUSION CRITERIA: Consented children aged 5‐13 years presenting with primary non‐bullous impetigo in participating schools who currently are part of sore throat national programme to prevent rheumatic fever and have on site school nurses for this programme.