N/A N=40 Randomized Quadruple-blind Supportive Care

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

Cellulitis

Bottom Line

View on ClinicalTrials.gov: NCT01671423 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours — 79.64; 56.45; 39.71; 25.91 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Prednisone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Albert Einstein Healthcare Network
Primary completion: Sep 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours	79.64; 56.45; 39.71; 25.91	—
SECONDARY Amount of Pain Medication - Day 1 to 48 Hours	7; 2	—
SECONDARY Amount of Pain Medication - Day 1 to 7 Days	—	—
SECONDARY Amount of Pain Medication - 48 Hours to 7 Days	—	—
SECONDARY Number of Participants Requiring Additional Medical Assistance Post-Randomization	—	—
SECONDARY Disposition Trend	12; 8; 2; 3	—
SECONDARY Adverse Events (AE)	—	—
SECONDARY Change in Erythema Size - Day 1 to 48 Hours	—	—

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.

Eligibility Criteria

Inclusion Criteria

Age 18 to 70 years
Current episode of cellulitis
Erythema greater than 5 centimeters in any dimension
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:
Steroids
Acetaminophen
Trimethoprim-Sulphamethoxazole (TMP/SMX), Cephalexin, and Clindamycin (must be allergic to all three for exclusion)
Oxycodone and Hydrocodone (must be allergic to both for exclusion)
If subject is going to the Observation unit, allergy to:
Clindamycin and Vancomycin (must be allergic to both for exclusion)
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:
Sepsis
Hypotension (systolic pressure < 90 mmHg or reduction of 40 mmHg from baseline)
Failure of single end organ
Suspicion or presence of septic shock, as defined by:
Severe sepsis
Hypotension that is refractory to fluid management
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01671423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.