The Use of Oral Steroids in the Treatment of Cellulitis

July 21, 2017 updated by: Milton S. Hershey Medical Center

Utility of Prednisone in the Treatment of Cellulitis

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Drug: Placebo Oral Tablet
Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to cellulitis resolving
Time Frame: 48 hours after initiation of treatment
48 hours after initiation of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of stay
Time Frame: after treatment completed
after treatment completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Scott Goldstein, DO, Penn State

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2010

Primary Completion (Actual)

August 31, 2010

Study Completion (Actual)

August 31, 2010

Study Registration Dates

First Submitted

May 1, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (Estimate)

May 5, 2009

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8876

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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