Soft Tissue Ultrasound of Infections
Primary Purpose
Soft Tissue Infections, Cellulitis, Abscess
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Soft Tissue Infections focused on measuring skin, soft tissue, infection, cellulitis, abscess
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- Ability to understand risks/benefits and consent to participation in the study
- Ability to read and understand English or Spanish
- Primary diagnosis for admission is SSTI, including cellulitis, abscess, fasciitis, myositis
- Requiring admission to an inpatient service
Exclusion Criteria:
- Patients in custody of law enforcement
- Patients on a psychiatric hold
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ultrasound
Arm Description
Single interventional group - patients agree to an ultrasound of their skin or soft tissue infection and an ultrasound to an uninfected portion of skin.
Outcomes
Primary Outcome Measures
Discharge diagnosis
Discharge diagnosis will be collected by retrospective chart review
Secondary Outcome Measures
Disposition after admission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01557426
Brief Title
Soft Tissue Ultrasound of Infections
Official Title
Soft Tissue Ultrasound of Infections
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objectives:
This study aims to characterize severe skin and soft tissue infections (SSTIs) in the emergency department through the acquisition of ultrasound images. A wide range of SSTIs will be imaged and recorded, leading to a registry of these infections. The registry will show whether ED (emergency department) sonographers can accurately characterize these infections, as compared to the final hospital diagnosis. The registry will also provide data for a case-control study comparing ultrasonographic characteristics of necrotizing skin and soft tissue infections (NSTIs) to those of non-necrotizing SSTIs.
Research procedures:
In this study, the investigators will approach patients who present to the Emergency Department with a possible skin and/or tissue infection. Study subjects must be ED patients requiring admission to the hospital for the primary problem of an SSTI due to the need for follow-up. If the patient consents to participating in the study, the investigator will obtain and record an ultrasound image of the infected area. An ultrasound image of an uninfected area of skin will also be recorded for comparison. Patient information regarding personal history, physical examination, blood tests and x-rays will also be gathered from participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Infections, Cellulitis, Abscess
Keywords
skin, soft tissue, infection, cellulitis, abscess
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound
Arm Type
Other
Arm Description
Single interventional group - patients agree to an ultrasound of their skin or soft tissue infection and an ultrasound to an uninfected portion of skin.
Intervention Type
Other
Intervention Name(s)
Ultrasound
Intervention Description
A linear ultrasound transducer will be used with ultrasound gel to obtain an image of subcutaneous structures and tissues over the involved body site. Ultrasound video will be recorded whenever possible, however studies that are not recorded will still be included. Video recording will be initiated once the desired image is obtained. Appropriate measurements will be made and views identified using the features of the ultrasound machine. Scanning of the contralateral body segment will then be performed. The ultrasound probe will be thoroughly cleaned and disinfected between ultrasound scans.
Primary Outcome Measure Information:
Title
Discharge diagnosis
Description
Discharge diagnosis will be collected by retrospective chart review
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disposition after admission
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
Ability to understand risks/benefits and consent to participation in the study
Ability to read and understand English or Spanish
Primary diagnosis for admission is SSTI, including cellulitis, abscess, fasciitis, myositis
Requiring admission to an inpatient service
Exclusion Criteria:
Patients in custody of law enforcement
Patients on a psychiatric hold
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Otto Liebmann, MD
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Soft Tissue Ultrasound of Infections
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