NCT01557426

Soft Tissue Ultrasound of Infections

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Rhode Island Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Infections
• Cellulitis
• Abscess

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-12-01
• Completion: 2015-03-01
• First posted: 2012-03-19
• Last updated: 2015-04-29

Locations

1 site across 1 country: United States