None listed
Conditions
Brief summary
The use of steroids in combination with antibiotics for cellulitis may reduce symptoms, such as swelling, warmth, pain and redness for patients and time to resolution of the infection. For the Emergency Department (ED) this may mean a reduction in admissions into hospital/observation unit, the use of secondary antibiotics, and re-presentation to the ED. The study is designed as a double-blind placebo-controlled study with the use of a single dose of 50mg prednisolone or a single dose of placebo alongside standard care of antibiotics on first presentation of cellulitis to the ED. Measurement of time to resolution of symptoms will be obtained by telephone follow up at day 3 and 7, also at day 14 if infection has not resolved. Electronic medical records will be checked at day 28 to see if the participant re-presented to ED. There is a suggestion from limited previous research that courses of steroids in cellulitis alongside standard care (antibiotics) have reduced hospital stays. This study will focus on patients discharged from ED with oral antibiotics. Primarily, comparisons will be made between the two groups (steroid vs placebo) to determine if there is a statistically significant difference in time to resolution and patient’s perceived symptoms. The secondary objective will be to compare rates of re-presentation to the ED
Interventions
The intervention is the administration of a single 50mg dose of prednisolone alongside standard antibiotics for treatment of cellulitis (a skin infection). This will be given as an oral tablet, alongside their initial dose of antibiotics in the department - there will be no further doses of the intervention therefore adherence does not need to be monitored. The antibiotics given will follow and comply with the hospital antibiotic protocol, and dependent on their allergies - this is the standard
The intervention is the administration of a single 50mg dose of prednisolone alongside standard antibiotics for treatment of cellulitis (a skin infection). This will be given as an oral tablet, alongside their initial dose of antibiotics in the department - there will be no further doses of the intervention therefore adherence does not need to be monitored. The antibiotics given will follow and comply with the hospital antibiotic protocol, and dependent on their allergies - this is the standard care all patients with cellulitis will receive, regardless of whether a participant in the study. The antibiotic given is not relevant to this study, but will be recorded on a data collection sheet. As normal practice in Hervey Bay, they will be given a prescription for the remainder of their antibiotic course. There is a suggestion from previous research that a course of prednisolone may improve time to resolution of symptoms in cellulitis, and also reduce hospital stay. This study will try to identify if a single dose of prednisolone has an effect of cellulitis. Participants will be identified by primary clinicians when seen in the Emergency Department. A single 50mg dose of prednisolone will be given alongside initial antibiotic dose in the Emergency Department by the primary clinician. No further doses/exposure will be given and the participant will continue standard care with antibiotic. The participants will be given an information sheet, will have an opportunity to ask questions and informed consent to participate will be documented.
Sponsors
Wide Bay Hospitals and Health Services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
- Cellulitis effecting trunk or limb - Aged 18-75 years - Able to give informed consent - For treatment with antibiotics - First presentation of acute episode - Patients who are admitted to and discharged from the ED or admitted to Hospital in the Home (HITH)
Exclusion criteria
- Below 18 years of age or above 75 years of age - Inability to consent - Adrenal insufficiency - Steroid use in the last 2 weeks - Allergy to steroids - Admitted into hospital - Immunocompromised - Abnormal vital signs (HR >110, BP <100/60, respiration rate >22, O2 saturation <90%) - Pregnancy or breast feeding - In a correctional facility
Outcome results
None listed