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Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis

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ClinicalTrials.gov Identifier: NCT01671423
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
Scott Goldstein, DO, Albert Einstein Healthcare Network

Study Description
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Brief Summary:
Cellulitis is the medical term for an infection of the skin, with symptoms including redness, swelling, warmth, and pain. This group of symptoms is called inflammation, and is caused by the body's immune system responding to the infection. Standard care for cellulitis is using antibiotics to destroy the infection, but the inflammation can persist and cause a great deal of pain. The hypothesis of this study is that adding a single dose of an oral steroid (prednisone), which tempers the immune response, will reduce inflammation, reduce pain, and speed recovery. This hypothesis will be examined by recruiting a group of patients with cellulitis, and randomizing them to two sub-groups: one group will receive a dose of prednisone, while the other group will receive a placebo. Neither group will know what they received unless there is a problem. These subjects will be followed up at the 48 hour mark and the 7 day mark, and will have their results compared.

Condition or disease Intervention/treatment Phase
Cellulitis Drug: Prednisone Drug: Placebo Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis
Study Start Date : August 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cellulitis Steroids
Drug Information available for: Prednisone

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Prednisone
In addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.
 Drug: Prednisone
See "Prednisone" arm description
Other Names:
  • Deltasone
  • Prednicot
  • Sterapred
Placebo Comparator: Placebo
In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.
 Drug: Placebo
See "Placebo" arm description
Other Names:
  • Sugar Pill
  • Inactive Drug
  • Control


Outcome Measures
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Primary Outcome Measures :
  1. Change in VAS for pain - day 1 to 48 hours [ Time Frame: Assessed once at day 1 and then once during the 48 hour follow-up ]
    Difference between the level of pain as measured by a Visual Analog Scale measured once at day 1 and once during the 48 hour follow-up visit.


Secondary Outcome Measures :
  1. Amount of pain medication - day 1 to 48 hours [ Time Frame: Assessed once during the 48 hour follow-up ]
    Amount of pain medication the subject needed to use between day 1 and the 48 hour follow-up

  2. Amount of pain medication - day 1 to 7 days [ Time Frame: Assessed once during the 7 day follow-up ]
    Total amount of pain medication used between day 1 and the 7 day follow-up call.

  3. Amount of pain medication - 48 hours to 7 days [ Time Frame: Assessed at the 48 hour follow-up and at the 7 day follow-up ]
    Amount of pain medication the subject needed to use between the 48 hour follow-up and the 7 day follow-up.

  4. Additional Medical Assistance Post-Randomization [ Time Frame: Assessed continuously from day 1 to the day 7 follow-up call ]
    Need for additional medical intervention to treat the current episode of cellulitis.

  5. Disposition Trend [ Time Frame: Assessed once during day 1 ]
    Disposition of the subject at the end of the initial visit on day 1 to home or to the observation unit

  6. Adverse Events [ Time Frame: Assessed continuously from day 1 to day 7 follow-up ]
    Development of adverse events during study period such as: allergic reaction, development of severe sepsis or septic shock, crepitus, change in mentation, fever greater than or equal to 39 degrees Celsius, tachycardia (heart rate over 120 beats per minute)

  7. Change in erythema size - day 1 to 48 hours [ Time Frame: Assessed once at day 1 and once during the 48 hour follow-up visit ]
    Difference between the measured amount of erythema during day 1 and during the 48 hour follow-up visit


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 70 years

  • Current episode of cellulitis

    1. Erythema greater than 5 centimeters in any dimension
    2. Pain, swelling, warmth, and tenderness in the area without elevated borders
  • Dispositioned for discharge from the Emergency Department or Observation
  • Able to consent

Exclusion Criteria:

  • Steroid use in the past 2 weeks
  • History of adrenal insufficiency
  • Any infection treated with antibiotics in the past 2 weeks

  • Allergy to:

    1. Steroids
    2. Acetaminophen
    3. Trimethoprim-Sulphamethoxazole (TMP/SMX), Cephalexin, and Clindamycin (must be allergic to all three for exclusion)
    4. Oxycodone and Hydrocodone (must be allergic to both for exclusion)

  • If subject is going to the Observation unit, allergy to:

    1. Clindamycin and Vancomycin (must be allergic to both for exclusion)
    2. Morphine and Hydromorphone (must be allergic to both for exclusion)
  • Suspicion or presence of abscess
  • Suspicion or presence of deep vein thrombosis

  • Suspicion or presence of severe sepsis, as defined by:

    1. Sepsis
    2. Hypotension (systolic pressure < 90 mmHg or reduction of 40 mmHg from baseline)
    3. Failure of single end organ

  • Suspicion or presence of septic shock, as defined by:

    1. Severe sepsis
    2. Hypotension that is refractory to fluid management
    3. Failure or more than one end organ
  • Crepitus
  • Change in mentation
  • Tachycardia greater than 120 beats per minute
  • Fever greater than or equal to 39 degrees Celsius
  • Hospital admission
  • Under 18 years of age, or over 70 years of age
  • Pregnancy or breast feeding
  • Police custody or prisoner
  • Cognitive impairment
  • Inability to consent
  • Nursing home residents
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671423


Locations
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
Principal Investigator: Scott Goldstein, DO Albert Einstein Healthcare Network
More Information
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Publications:

Responsible Party: Scott Goldstein, DO, Attending Physician, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT01671423     History of Changes
Other Study ID Numbers: HN 4372
First Posted: August 23, 2012    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Scott Goldstein, DO, Albert Einstein Healthcare Network:
Cellulitis
Skin infection
Prednisone
Steroid
Anti-inflammatory

Additional relevant MeSH terms:
Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Prednisone
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents