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

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

Overview[ - collapse ][ - ]

Purpose	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	Cellulitis
Intervention	Drug: Prednisone Drug: Placebo
Phase	N/A
Sponsor	Albert Einstein Healthcare Network
Responsible Party	Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier	NCT01671423
First Received	August 14, 2012
Last Updated	March 21, 2013
Last verified	March 2013

Tracking Information[ + expand ][ + ]

First Received Date	August 14, 2012
Last Updated Date	March 21, 2013
Start Date	August 2012
Estimated Primary Completion Date	December 2014
Current Primary Outcome Measures	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] [Designated as safety issue: No]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] [Designated as safety issue: No]Difference between the measured amount of erythema during day 1 and during the 48 hour follow-up visit
Current Secondary Outcome Measures	Amount of pain medication - day 1 to 48 hours [Time Frame: Assessed once during the 48 hour follow-up] [Designated as safety issue: No]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] [Designated as safety issue: No]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] [Designated as safety issue: No]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] [Designated as safety issue: No]Need for additional medical intervention to treat the current episode of cellulitis. Disposition Trend [Time Frame: Assessed once during day 1] [Designated as safety issue: No]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] [Designated as safety issue: Yes]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)

Descriptive Information[ + expand ][ + ]

Brief Title	Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis
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 Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Condition	Cellulitis
Intervention	Drug: Prednisone See "Prednisone" arm description Other Names: Prednisone Deltasone Prednicot Sterapred Drug: Placebo See "Placebo" arm description Other Names: Sugar Pill Inactive Drug Control
Study Arm (s)	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. Placebo Comparator: Placebo In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	100
Estimated Completion Date	December 2014
Estimated Primary Completion Date	August 2014
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Kathia Damiron 215-456-6623 DamironK@einstein.edu
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01671423
Other Study ID Numbers	HN 4372
Has Data Monitoring Committee	Yes
Information Provided By	Albert Einstein Healthcare Network
Study Sponsor	Albert Einstein Healthcare Network
Collaborators	Not Provided
Investigators	Principal Investigator: Scott Goldstein, DO Albert Einstein Healthcare Network
Verification Date	March 2013

Locations[ + expand ][ + ]