The Use of Oral Steroids in the Treatment of Cellulitis
Primary Purpose
Cellulitis, Erysipelas
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Prednisone
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Cellulitis focused on measuring prednisone, cellulitis, erysipelas, steroids, oral
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Prednisone
Placebo
Arm Description
Use of prednisone to decrease LOS and overall treatment time of cellulitis
Outcomes
Primary Outcome Measures
Time to cellulitis resolving
Secondary Outcome Measures
Length of stay
Full Information
NCT ID
NCT00893048
First Posted
May 1, 2009
Last Updated
July 21, 2017
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00893048
Brief Title
The Use of Oral Steroids in the Treatment of Cellulitis
Official Title
Utility of Prednisone in the Treatment of Cellulitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study never enrolled any subjects before auto-terminated by the internal IRB.
Study Start Date
January 15, 2010 (Actual)
Primary Completion Date
August 31, 2010 (Actual)
Study Completion Date
August 31, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis, Erysipelas
Keywords
prednisone, cellulitis, erysipelas, steroids, oral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisone
Arm Type
Experimental
Arm Description
Use of prednisone to decrease LOS and overall treatment time of cellulitis
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
sterapred, sterapred DS
Intervention Description
Prednisone, 60 mg, one time at time of diagnosis
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Time to cellulitis resolving
Time Frame
48 hours after initiation of treatment
Secondary Outcome Measure Information:
Title
Length of stay
Time Frame
after treatment completed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Goldstein, DO
Organizational Affiliation
Penn State
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Use of Oral Steroids in the Treatment of Cellulitis
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