Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis
This study has been completed.
First Posted: August 23, 2012
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Information provided by (Responsible Party):
Scott Goldstein, DO, Albert Einstein Healthcare Network
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.
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
||Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis
Primary Outcome Measures:
Secondary Outcome Measures:
- 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
- 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.
- 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.
- 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.
- 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
- 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)
- 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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2015 (Final data collection date for primary outcome measure)
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.
See "Prednisone" arm description
Placebo Comparator: Placebo
In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.
See "Placebo" arm description
- Sugar Pill
- Inactive Drug