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Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis
This study has been completed.
Sponsor:
Albert Einstein Healthcare Network
Information provided by (Responsible Party):
Scott Goldstein, DO, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT01671423
First received: August 14, 2012
Last updated: May 4, 2017
Last verified: May 2017
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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 | Intervention |
|---|---|
| Cellulitis | Drug: Prednisone Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 |
Resource links provided by NLM:
Further study details as provided by Scott Goldstein, DO, Albert Einstein Healthcare Network:
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 ]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.
Secondary Outcome Measures:
- 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
| Enrollment: | 42 |
| Study Start Date: | August 2012 |
| Study Completion Date: | September 2015 |
| Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Prednisone
See "Prednisone" arm description
Other Names:
|
|
Placebo Comparator: Placebo
In addition to standard care for cellulitis, subjects will receive a single placebo pill to take during their initial visit.
|
Drug: Placebo
See "Placebo" arm description
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671423
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671423
Locations
| United States, Pennsylvania | |
| Albert Einstein Medical Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
| Principal Investigator: | Scott Goldstein, DO | Albert Einstein Healthcare Network |
More Information
Publications:
| Responsible Party: | Scott Goldstein, DO, Attending Physician, Albert Einstein Healthcare Network |
| ClinicalTrials.gov Identifier: | NCT01671423 History of Changes |
| Other Study ID Numbers: |
HN 4372 |
| Study First Received: | August 14, 2012 |
| Last Updated: | May 4, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Scott Goldstein, DO, Albert Einstein Healthcare Network:
|
Cellulitis Skin infection Prednisone Steroid Anti-inflammatory |
Additional relevant MeSH terms:
|
Cellulitis Skin Diseases, Infectious Infection Suppuration Connective Tissue Diseases Inflammation Pathologic Processes Prednisone |
Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on August 18, 2017