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Soft Tissue Ultrasound of Infections

Soft Tissue Ultrasound of Infections

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01557426
Enrollment
15
Registered
2012-03-19
Start date
2012-03-31
Completion date
2015-03-31
Last updated
2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abscess, Cellulitis, Soft Tissue Infections

Keywords

skin, soft tissue, infection, cellulitis, abscess

Brief 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.

Interventions

OTHERUltrasound

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.

Sponsors

Rhode Island Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Discharge diagnosis2 yearsDischarge diagnosis will be collected by retrospective chart review

Secondary

MeasureTime frame
Disposition after admission2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026