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

Cellulitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cellulitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PrednisoneSee "Prednisone" arm description

Drug:PlaceboSee "Placebo" arm description

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PrednisoneIn addition to standard care for cellulitis, subject will receive a single 60 mg dose of Prednisone orally during their initial visit.

PlaceboIn addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.

Study Status

Completed

Start Date: August 2012

Completed Date: September 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change in VAS for pain - day 1 to 48 hours

Secondary Outcome: Amount of pain medication - day 1 to 48 hours

Study sponsors, principal investigator, and references

Principal Investigator: Scott Goldstein, DO

Lead Sponsor: Albert Einstein Healthcare Network

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01671423

Bergkvist PI, Sjöbeck K. Antibiotic and prednisolone therapy of erysipelas: a randomized, double blind, placebo-controlled study. Scand J Infect Dis. 1997;29(4):377-82.

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