Soft Tissue Ultrasound of Infections

Lifespan

Status and phase: Completed; Phase 1

Conditions: Cellulitis; Soft Tissue Infections; Abscess

Treatments: Other: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT01557426

304321

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Ultrasound

Other group

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.

Treatment:

Other: Ultrasound