Soft Tissue Ultrasound of Infections

This study has been completed.
Information provided by (Responsible Party):
Rhode Island Hospital Identifier:
First received: March 15, 2012
Last updated: April 28, 2015
Last verified: March 2012


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.

Condition Intervention Phase
Soft Tissue Infections
Other: Ultrasound
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Soft Tissue Ultrasound of Infections

Resource links provided by NLM:

Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Discharge diagnosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Discharge diagnosis will be collected by retrospective chart review

Secondary Outcome Measures:
  • Disposition after admission [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: March 2012
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single interventional group - patients agree to an ultrasound of their skin or soft tissue infection and an ultrasound to an uninfected portion of skin.
Other: Ultrasound
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT01557426

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Principal Investigator: Otto Liebmann, MD Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Rhode Island Hospital Identifier: NCT01557426     History of Changes
Other Study ID Numbers: 304321
Study First Received: March 15, 2012
Last Updated: April 28, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
soft tissue

Additional relevant MeSH terms:
Communicable Diseases
Soft Tissue Infections
Connective Tissue Diseases
Pathologic Processes
Skin Diseases, Infectious
Suppuration processed this record on October 13, 2015