Trial record 11 of 162 for:    Open Studies | "Skin Diseases, Infectious"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Albert Einstein Healthcare Network
Sponsor:
Information provided by (Responsible Party):
Scott Goldstein, DO, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier:
NCT01671423
First received: August 14, 2012
Last updated: June 26, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ 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.


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)

  • 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


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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:
  • Prednisone
  • Deltasone
  • Prednicot
  • Sterapred
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:
  • Sugar Pill
  • Inactive Drug
  • Control

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Contacts
Contact: Kathia Damiron 215-456-6623 DamironK@einstein.edu
Contact: Scott Goldstein, DO 215-456-6679 Goldste@einstein.edu

Locations
United States, Pennsylvania
Albert Einstein Medical Center Recruiting
Philadephia, Pennsylvania, United States, 19141
Principal Investigator: Scott Goldstein, DO         
Sub-Investigator: Milciades A. Mirre-Gonzalez         
Sub-Investigator: Abdullah Khalid         
Sub-Investigator: Kathia Damiron         
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: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein Healthcare Network:
Cellulitis
Skin infection
Prednisone
Steroid
Anti-inflammatory

Additional relevant MeSH terms:
Skin Diseases, Infectious
Cellulitis
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 23, 2014