The Use of Oral Steroids in the Treatment of Cellulitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Penn State University.
Recruitment status was  Not yet recruiting
Information provided by:
Penn State University Identifier:
First received: May 1, 2009
Last updated: May 4, 2009
Last verified: May 2009
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
Drug: Prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Utility of Prednisone in the Treatment of Cellulitis

Resource links provided by NLM:

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Time to cellulitis resolving [ Time Frame: 48 hours after initiation of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of stay [ Time Frame: after treatment completed ] [ Designated as safety issue: No ]

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
Experimental: Prednisone
Use of prednisone to decrease LOS and overall treatment time of cellulitis
Drug: Prednisone
Prednisone, 60 mg, one time at time of diagnosis
Other Names:
  • sterapred
  • sterapred DS

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18-70 years old
  • signs/symptoms of cellulitis

Exclusion Criteria:

  • steroid use in last 2 weeks
  • hx of adrenal insufficiency
  • suspicion for dvt or abcess
  • systemic signs of sepsis
  • ICU admission
  Contacts and Locations
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Please refer to this study by its identifier: NCT00893048

Contact: Scott Goldstein, DO 717-531-8955 ext opt 5

Sponsors and Collaborators
Penn State University
Principal Investigator: Scott Goldstein, DO Penn State
  More Information

Responsible Party: Scott Goldstein, Penn State University Identifier: NCT00893048     History of Changes
Other Study ID Numbers: 8876 
Study First Received: May 1, 2009
Last Updated: May 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:

Additional relevant MeSH terms:
Bacterial Infections
Connective Tissue Diseases
Gram-Positive Bacterial Infections
Pathologic Processes
Skin Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Streptococcal Infections
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 26, 2016