search
Back to results

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Withdrawn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
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cellulitis focused on measuring prednisone, cellulitis, erysipelas, steroids, oral

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 1, 2009
    Last Updated
    July 21, 2017
    Sponsor
    Milton S. Hershey Medical Center
    search

    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    Withdrawn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

    We'll reach out to this number within 24 hrs