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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
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00893048
First received: May 1, 2009
Last updated: May 4, 2009
Last verified: May 2009
  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 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
  • prednisone

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00893048

Contacts
Contact: Scott Goldstein, DO 717-531-8955 ext opt 5 sgoldstein1@hmc.psu.edu

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

No publications provided

Responsible Party: Scott Goldstein, Penn State University
ClinicalTrials.gov 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:
prednisone
cellulitis
erysipelas
steroids
oral

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

ClinicalTrials.gov processed this record on November 20, 2014