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

NCT01671423 | Completed Results DMC

• 1 other identifier: HN 4372
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cellulitis

Keywords

Cellulitis; Skin infection; Prednisone; Steroid; Anti-inflammatory

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale(VAS) for Pain - Day 1 to 48 Hours

  The level of pain as measured by a Visual Analog Scale(VAS) measured once at day 1 and once during the 48th hour follow-up visit. Minimum value 0, maximum value 100mm, higher scores corresponds to more pain/worse outcomes.

  Assessed once at day 1 and then once during the 48 hour follow-up

Secondary Outcomes (7)

• Amount of Pain Medication - Day 1 to 48 Hours

  Assessed once during the 48 hour follow-up

• Amount of Pain Medication - Day 1 to 7 Days

  Assessed once during the 7 day follow-up

• Amount of Pain Medication - 48 Hours to 7 Days

  Assessed at the 48 hour follow-up and at the 7 day follow-up

• Number of Participants Requiring Additional Medical Assistance Post-Randomization

  Assessed continuously from day 1 to the day 7 follow-up call

• Disposition Trend

  Assessed once during day 1

Study Arms (2)

Prednisone

ACTIVE COMPARATOR

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

Drug: Prednisone

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Prednisone DRUG

See "Prednisone" arm description

Also known as: Deltasone, Prednicot, Sterapred

Prednisone

Placebo DRUG

See "Placebo" arm description

Also known as: Sugar Pill, Inactive Drug, Control

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• If subject is going to the Observation unit, allergy to:
• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (5)

• Bergkvist PI, Sjobeck K. Antibiotic and prednisolone therapy of erysipelas: a randomized, double blind, placebo-controlled study. Scand J Infect Dis. 1997;29(4):377-82. doi: 10.3109/00365549709011834.

  PMID: 9360253 BACKGROUND

• Kiderman A, Yaphe J, Bregman J, Zemel T, Furst AL. Adjuvant prednisone therapy in pharyngitis: a randomised controlled trial from general practice. Br J Gen Pract. 2005 Mar;55(512):218-21.

  PMID: 15808038 BACKGROUND

• Qi D, Pulinilkunnil T, An D, Ghosh S, Abrahani A, Pospisilik JA, Brownsey R, Wambolt R, Allard M, Rodrigues B. Single-dose dexamethasone induces whole-body insulin resistance and alters both cardiac fatty acid and carbohydrate metabolism. Diabetes. 2004 Jul;53(7):1790-7. doi: 10.2337/diabetes.53.7.1790.

  PMID: 15220203 BACKGROUND

• Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.

  PMID: 8604867 BACKGROUND

• Yen MT, Yen KG. Effect of corticosteroids in the acute management of pediatric orbital cellulitis with subperiosteal abscess. Ophthalmic Plast Reconstr Surg. 2005 Sep;21(5):363-6; discussion 366-7. doi: 10.1097/01.iop.0000179973.44003.f7.

  PMID: 16234700 BACKGROUND

MeSH Terms

Conditions

Cellulitis

Interventions

Prednisone; Sugars

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Carbohydrates

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Scott Goldstein
• Organization: Einstein Medical Center

goldstes@einstein.edu

2154561836

Study Officials

• Scott Goldstein, DO

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: August 23, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 10, 2021
• Results First Posted: February 10, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)