Soft Tissue Ultrasound of Infections

Cellulitis Clinical Trial

Official title:

Soft Tissue Ultrasound of Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557426
• Other study ID #: 304321
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2012
• Last updated: April 28, 2015
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: March 2012
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abscess
• Cellulitis
• Communicable Diseases
• Infection
• Soft Tissue Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discharge diagnosis	Discharge diagnosis will be collected by retrospective chart review	2 years	No
Secondary	Disposition after admission		2 years	No