Impetigo is a bacterial infection of very common skin in the pediatric population. In the usual clinical practice, the treatment of this infection has been based on topical antibiotics. The widespread use of antibiotics contributes to the increase of resistance. Focusing on the forms of localized impetigo, there are studies that suggest that treatment with topical antiseptics could be a good treatment option.
Conditions
Interventions
Trade Name: 1% aqueous chlorhexidine.
Pharmaceutical Form: Concentrate for cutaneous spray, emulsion
Trade Name: 2% fusidic acid cream
Pharmaceutical Form: Cream
Sponsors
Hospital Universitario Son Llàtzer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients who consult in the pediatric emergency service, who meet the following criteria: - Age between 1 year and 13 years (inclusive). - Patients diagnosed with localized non-bullous impetigo. - Not having received previous antibiotic treatment for the same episode. - Parents / legal guardians who agree to participate in the study and sign the informed consent, after the relevant explanation of the study. Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients under one year of age or over 14 years of age. - Children with comorbidities (corticosteroid treatment, chronic pathology ...) - Patients who have received previous antibiotic treatment in the same episode - Patients with extensive / severe impetigo or bullous forms. -Lesions in particular locations, such as the periocular area or areas of sensitive skin, not subsidiary to treatment with topical antiseptic. -Parents / guardians who do not agree to participate in the study or revoke the signature of the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of treatment with topical antiseptics versus topical antibiotherapy in the treatment of mild impétigo of pediatric age.;Secondary Objective: - Know the remission time of impetigo in the two treatment arms. - Know the percentage of impregites that evolve in each arm and specify another line of treatment. - Determine the causative bacterial agent of impestight with bad initial evolution. - Determine the cost-effectiveness of treatment with topical antiseptic.;Primary end point(s): the effectiveness of the treatment: - Response of injuries to treatment (0 Inadequate, 1 adequate) - Evolution to serious forms (extensive lesions, staphylococcal scald ...) - Adverse effects according to treatment (0 no, 1 yes) - Requires entry (0 no, 1 Yes) - Culture is collected (0 no, 1 Yes) - Positive culture (0 no, 1 Yes) - Causal agent (0 Staphylococcus, 1 Streptococcus, 2 others) - Result antibiogram (determine the causative agent);Timepoint(s) of evaluation of this end point: the effectiveness of the treatment will be measured at 72 hours and subsequently at 7 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): DEMOGRAPHIC VARIABLES: - Patient history number - Age (in months) - Sex (0 female, 1 male) - Person in charge of treatment at home (0 Mother, 1 Father, 2 both indistinctly, 3 another relative, own patient) - History of atopy (0 No, 1 Yes) - Drug allergies (0 No, 1 Yes) - Other allergies (0 No, 1. Yes) VARIABLES PRIOR TO TREATMENT - Treatment that the patient will receive (0. Topical antibiotic - odd days of the month; 1. Antiseptic - Even days of the month). - Injury area (0.face, 1.legs, 2. Trunk) - Initial injury (0 sting, 1 nonspecific injury, 2 do not remember that there was injury) - Days of evolution of the lesions (in hours) - Reconsultation for injuries (previously visit in health center or emergency room) (0 no, 1 Yes).;Timepoint(s) of evaluation of this end point: The demographic variables and the variables prior to treatment will be measured at the moment of inclusion of the patient, in the visit 0. | — |
Countries
Spain
Contacts
Public ContactSara Melgar Diaz
Hospital Universitario Son Llàtzer
Outcome results
None listed