- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01773499
Sonographic Features of Cellulitis and Failure of Therapy
March 18, 2015 updated by: Romolo Gaspari, University of Massachusetts, Worcester
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.
Study Overview
Status
Terminated
Conditions
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.
Study Type
Observational
Enrollment (Actual)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- UMass Memorial Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Cellulitis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patient with Cellulitis
Patients with uncomplicated cellulitis treated as outpatients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Failure of therapy
Time Frame: 7 days
|
Patients with change in antibiotics or hospital admission
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Romolo J Gaspari, MD, PhD, UMass Memorial Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
January 17, 2013
First Submitted That Met QC Criteria
January 22, 2013
First Posted (Estimate)
January 23, 2013
Study Record Updates
Last Update Posted (Estimate)
March 20, 2015
Last Update Submitted That Met QC Criteria
March 18, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMASSEDUS3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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