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
|Condition or disease||Intervention/treatment||Phase|
|Cellulitis||Drug: Prednisone Drug: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|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|
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
- 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.
- 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
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
|United States, Pennsylvania|
|Albert Einstein Medical Center|
|Philadelphia, Pennsylvania, United States, 19141|
|Principal Investigator:||Scott Goldstein, DO||Albert Einstein Healthcare Network|