None listed
Conditions
Brief summary
Skin sepsis is a common problem among children and severe skin infections are the most common reason for hospitalisation in NZ children. Pacific and Maori children are more likely to develop cellulitis than their NZ European counterparts and hospital admissions for skin sepsis occur at more than twice the rate in NZ compared with other developed countries. Evidence-based clinical guidelines for the treatment of mild to moderate impetigo recommend the use of fusidic acid cream, currently funded topical antimicrobial in NZ. Recent data, however, have identified a high rate of community resistance to this medication amongst Staphylococcus aureus (SA) ; resistance >30%. This is linked to widespread community use of this topical antibiotic. The evidence base for alternative treatment strategies for mild impetigo is limited and judicious use of topical antibacterials is needed. Alternative therapies must be urgently found to prevent increasing resistance. The overall aim of the research is to compare two alternative treatments with the current standard of care treatment for mild-to-moderate impetigo among school children. Aims To undertake a non-inferiority trial comparing topical fusidic acid with (i) topical hydrogen peroxide, and (ii) with simple wound care in a community with both high rates of impetigo and increasing fusidic acid resistance. The results of this trial will inform evidence-based skin infection guidelines locally, nationally, and internationally including funding of best treatments.
Interventions
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 pa
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
Sponsors
Dr Alison Leversha
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 13 Years
Healthy volunteers
No
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.
Exclusion criteria
Immunocompromised, extensive lesions (>3) requiring oral antibiotics at presentation, known allergy to study drugs, cellulitis, temperature >38.5 C, patients who had used topical or oral antibiotics in the previous 5 days, and patients for whom informed consent is not obtained. T
Outcome results
None listed