Sonographic Features of Cellulitis and Failure of Therapy

This study has been terminated.
(Unable to enroll significant number of patients.)
Sponsor:
Information provided by (Responsible Party):
Romolo Gaspari, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01773499
First received: January 17, 2013
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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
Cellulitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sonographic Features of Cellulitis and Failure of Therapy

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Failure of therapy [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Patients with change in antibiotics or hospital admission


Enrollment: 3
Study Start Date: January 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patient with Cellulitis
Patients with uncomplicated cellulitis treated as outpatients

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Cellulitis

Criteria

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

  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: NCT01773499

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

No publications provided

Responsible Party: Romolo Gaspari, Associate Professor of Emergency Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01773499     History of Changes
Other Study ID Numbers: UMASSEDUS3
Study First Received: January 17, 2013
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
cellulitis
ultrasound

Additional relevant MeSH terms:
Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014