The Use of Oral Steroids in the Treatment of Cellulitis

NCT ID: NCT00893048

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-15
• Study Completion Date: 2010-08-31

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.

Conditions

Cellulitis; Erysipelas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Prednisone

Use of prednisone to decrease LOS and overall treatment time of cellulitis

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

Prednisone, 60 mg, one time at time of diagnosis

Placebo

Group Type: EXPERIMENTAL

Placebo Oral Tablet

Intervention Type: DRUG

Placebo

Interventions

Prednisone

Prednisone, 60 mg, one time at time of diagnosis

Intervention Type: DRUG

Placebo Oral Tablet

Placebo

Intervention Type: DRUG

Other Intervention Names

sterapred; sterapred DS

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Goldstein, DO

Role: PRINCIPAL_INVESTIGATOR

Penn State

Other Identifiers

8876

Identifier Type: -

Identifier Source: org_study_id