Cellulitis
Conditions
Keywords
Cellulitis, Soft Tissue Infections, Skin Diseases, Infectious, Corticosteroids, Glucocorticoids, Dexamethasone
Brief summary
The aim of this study is to evaluate the efficacy of addition of corticosteroid therapy to antibiotic treatment during the first 48 hours of admission to the hospital in patients with cellulitis and its impact in the duration of the stay.
Detailed description
Cellulitis is a common skin and soft tissue infection in the pediatric population. Although most of the time treatment could be administered on an ambulatory setting , sometimes it may require hospitalization and parenteral antibiotic administration. Using corticosteroids during antibiotic treatment may reduce inflammation and length of stay. Objective: to evaluate the efficacy of using corticosteroids as adjuvant treatment during the first 48 hours of treatment after hospitalization in patients with cellulitis. Patients and methods: this is a double blind, randomized, controlled trial that will take place at pediatric hospital, during one year. It will include children aged 1 month to 18 years, admitted due to cellulitis. Once included in the clinical trial, the patients will be randomized to receive dexamethasone 0,6 mg/kg/day or placebo (saline solution) during the first 48 hours. Considering an average stay of 4 ± 2 days, we calculated a sample size of 124 children (62 children per group) to detect a 25% difference (1 day reduction) in the length of stay, with a power of 80% and a confidence of 95%.
Interventions
DRUGDexamethasone
IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
DRUGNormal Saline
IV normal saline every 6 hours for 48 hours
Sponsors
Hospital General de Niños Pedro de Elizalde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children Aged 1 month to 18 years * Hospitalized due to cellulitis * Patients who have given their written informed consent to participate
Exclusion criteria
* Skin chronic diseases * Immunodeficiency (primary or acquired) * Chronic use of systemic corticosteroids * Sepsis * Varicella * History of adrenal insufficiency * Pregnancy or breast feeding * Uncontrolled diabetes mellitus * Known hypersensitivity to systemic or topical corticosteroids * Patient undergoing immunosuppressive therapy for another disease * Participation in another drug biomedical research * Any other contraindication for treatment with corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of stay | participants will be followed for the duration of hospital stay, an expected average of 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Fever duration | participants will be followed for the duration of hospital stay, an expected average of 5 days |
| Change in erythema size | Measured at admission and after 48 hours (at the end of corticosteroids treatment) |
| Need to change antibiotic treatment | participants will be followed for the duration of hospital stay, an expected average of 5 days |
| Abscessation or spontaneous drainage | participants will be followed for the duration of hospital stay, an expected average of 5 days |
Countries
Argentina
Outcome results
None listed