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Sonographic Features of Cellulitis and Failure of Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01773499
Recruitment Status : Terminated (Unable to enroll significant number of patients.)
First Posted : January 23, 2013
Last Update Posted : March 20, 2015
Information provided by (Responsible Party):
Romolo Gaspari, University of Massachusetts, Worcester

Brief Summary:
Skin and soft tissue infections represent a tremendous burden to the health care community with over 11.6 million ambulatory patients presenting annually in 2003 and 14.2 million in 2005. A Cochrane review of cellulitis found that there is limited data to support any specific antibiotic or even a specific length of antibiotic therapy, and that outpatient therapy for cellulitis is increasing. Soft tissue ultrasound has been shown to have utility in differentiating cellulitis from abscess but its role in patients with cellulitis is not well developed. Although speculative, the investigators hypothesize that sonographic features of cellulitis are associated with clinical improvement and successful therapy following antibiotics for patients with cellulitis.

Condition or disease

Detailed Description:
The primary objective is to determine if changes in the sonographic features of cellulitis are associated with failure of therapy. Patients with cellulitis treated in the ED with either intravenous or oral antibiotics will undergo imaging using a standardized ultrasound protocol. Patients will be screened and enrolled in the ED at the UMASS Memorial Medical Center. The study design is single center prospective observational trial involving adult patients with clinical signs of cellulitis requiring antibiotics but not admitted to the hospital. Patients will be imaged upon initial presentation to the ED. Patients discharged from the ED after the initial visit will return to the ED in 24 to 48 hours for a reassessment. Patients kept in the ED under observational status will undergo an identical reassessment. Clinical staff blinded to the ultrasound results will characterize patients as improving, no change or worsening based on progression of the erythema despite antibiotics or change in clinical status. Researchers blinded to the clinical data will review the ultrasound images to quantify the extent of the sonographic evidence of cellulitis compared to the extent of the erythema by physical exam findings.

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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sonographic Features of Cellulitis and Failure of Therapy
Study Start Date : January 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cellulitis

Patient with Cellulitis
Patients with uncomplicated cellulitis treated as outpatients

Primary Outcome Measures :
  1. Failure of therapy [ Time Frame: 7 days ]
    Patients with change in antibiotics or hospital admission

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Cellulitis

Inclusion Criteria:

  • 18 years or older Symptoms of cellulitis (localized warmth, erythema, swelling or tenderness)

Exclusion Criteria:

Admitted for inpatient antibiotics Unable to consent Septic appearing crepitus on exam animal bite soft tissue abscess osteomylitis cellulitis requiring surgical debridement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01773499

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United States, Massachusetts
UMASS Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
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Principal Investigator: Romolo J Gaspari, MD, PhD UMASS Memorial Medical Center

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Responsible Party: Romolo Gaspari, Associate Professor of Emergency Medicine, University of Massachusetts, Worcester Identifier: NCT01773499    
Other Study ID Numbers: UMASSEDUS3
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015
Keywords provided by Romolo Gaspari, University of Massachusetts, Worcester:
Additional relevant MeSH terms:
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Skin Diseases, Infectious
Connective Tissue Diseases
Pathologic Processes