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The Use of Oral Steroids in the Treatment of Cellulitis

This study has been withdrawn prior to enrollment.
(Study never enrolled any subjects before auto-terminated by the internal IRB.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00893048
First Posted: May 5, 2009
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Milton S. Hershey Medical Center
  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 Drug: Placebo Oral Tablet Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Time to cellulitis resolving [ Time Frame: 48 hours after initiation of treatment ]

Secondary Outcome Measures:
  • Length of stay [ Time Frame: after treatment completed ]

Enrollment: 0
Actual Study Start Date: January 15, 2010
Study Completion Date: August 31, 2010
Primary Completion Date: August 31, 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
Experimental: Placebo Drug: Placebo Oral Tablet
Placebo

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893048


Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Scott Goldstein, DO Penn State
  More Information

Responsible Party: Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00893048     History of Changes
Other Study ID Numbers: 8876
First Submitted: May 1, 2009
First Posted: May 5, 2009
Last Update Posted: July 25, 2017
Last Verified: July 2017

Keywords provided by Milton S. Hershey Medical Center:
prednisone
cellulitis
erysipelas
steroids
oral

Additional relevant MeSH terms:
Cellulitis
Erysipelas
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents