Clinical Trial: Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis
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.
Detailed Summary:
This pilot study will be conducted in a prospective, double-blinded, placebo-controlled, randomized fashion using a convenience sample of 100 subjects who come to the ED with signs and symptoms of cellulitis. Initial medical assessment will be made by an attending/senior resident according with established clinical procedures, including the history, physical examination, and vital signs. If by clinical assessment the patients meet eligibility criteria, then they will be approached by a research associate for screening, informed consent process, enrollment in the study, and data collection.
After the subjects understand and sign the informed consent form, they will be randomized to either the placebo group or treatment group. The EMCP pharmacy will be in charge of the randomization process. Once randomized, a standard source document (see data management section and appendix C for details) will be filled with information given by the subjects and in their charts. While study medication is given (time zero), subjects will receive a Visual Analog Scale (VAS) to rate their pain upon initial presentation along with determination of size of the cellulitic area. This will be done by determining the longest axis of the cellulitic area and measuring it (in mm) from the most proximal/lateral end towards the most distal/medial end, excluding any lymphangitic spread. The most proximal and distal area of erythema will be outlined.
While the standard treatment of care for cellulitis will be circumscribed according to already established protocols, the class of antibiotics and pain control that patients receive will depend on their disposition:
If discharged:
- Antibiotic prescriptions will be TMP/SMX 160/800
Sponsor: Albert Einstein Healthcare Network
Current Primary Outcome: 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.
Original Primary Outcome:
- 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.
- 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
Current Secondary Outcome:
- 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
Original Secondary Outcome:
- 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)
Information By: Albert Einstein Healthcare Network
Dates:
Date Received: August 14, 2012
Date Started: August 2012
Date Completion:
Last Updated: May 4, 2017
Last Verified: May 2017
- 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 ]
