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| Sponsor: | Penn State University |
|---|---|
| Information provided by: | Penn State University |
| ClinicalTrials.gov Identifier: | NCT00893048 |
Purpose
The prevalence of cellulitis in society is very high, as much as 3% of visits to Emergency Departments are for the treatment of this disease. The treatment of cellulitis varies depending on the severity. Low severity cases are treated with pain control and antibiotics by mouth and high severity are treated with antibiotics intravenously and pain control. The investigator's hypothesis is to see if the addition of steroids, which are known to decrease inflammation, will decrease the length of the disease process. If so, it will decrease the length of stay if IV antibiotics are needed, it will decrease duration of days out of work and decrease the overall pain control required and therefore patient satisfaction.
| Condition | Intervention | Phase |
|---|---|---|
|
Cellulitis Erysipelas |
Drug: Prednisone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Utility of Prednisone in the Treatment of Cellulitis |
| Estimated Enrollment: | 35 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Prednisone: Experimental
Use of prednisone to decrease LOS and overall treatment time of cellulitis
|
Drug: Prednisone
Prednisone, 60 mg, one time at time of diagnosis
|
The incidence of cellulitis is about 24.6 cases per 1000 person-years, which is an estimate, since cellulitis is not a reportable disease. In some Emergency Departments up to 3% of visits are for cellulitis. Depending on the severity of the disease, some are treated as outpatients, and others are admitted for IV antibiotics. In some Emergency Departments cases of cellulitis are treated in an observation area for 23 hours with doses of IV antibiotics. My proposed research is to see if the addition of one dose of prednisone the treatment will decrease the inflammatory reaction enough to decrease length of stay and treatment and increase patient satisfaction.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Scott Goldstein, DO | 717-531-8955 ext opt 5 | sgoldstein1@hmc.psu.edu |
| Principal Investigator: | Scott Goldstein, DO | Penn State |
More Information
| Responsible Party: | Penn State University ( Scott Goldstein ) |
| Study ID Numbers: | 8876 |
| Study First Received: | May 1, 2009 |
| Last Updated: | May 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00893048 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
prednisone cellulitis erysipelas steroids oral |
|
Anti-Inflammatory Agents Bacterial Infections Prednisone Antineoplastic Agents, Hormonal Skin Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Infection Hormones Glucocorticoids Pharmacologic Actions |
Inflammation Cellulitis Skin Diseases, Infectious Gram-Positive Bacterial Infections Pathologic Processes Streptococcal Infections Therapeutic Uses Skin Diseases, Bacterial Connective Tissue Diseases Erysipelas Suppuration |
