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Soft Tissue Ultrasound of Infections

This study is currently recruiting participants.
Verified March 2012 by Rhode Island Hospital
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT01557426
First received: March 15, 2012
Last updated: December 3, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Soft Tissue Infections
Cellulitis
Abscess
 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:

MedlinePlus related topics: Cellulitis
U.S. FDA Resources

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 ]

Estimated Enrollment: 15
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ultrasound
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557426

Contacts
Contact: Karina Bertsch, MSW, CCRP 401-444-9264 kbertsch@lifespan.org

Locations
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Karina Bertsch, MSW, CCRP     401-444-9264     kbertsch@lifespan.org    
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: Otto Liebmann, MD Rhode Island Hospital
  More Information

No publications provided

Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01557426     History of Changes
Other Study ID Numbers: 304321
Study First Received: March 15, 2012
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
skin
soft tissue
infection
cellulitis
abscess

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

ClinicalTrials.gov processed this record on May 21, 2013