Soft Tissue Ultrasound of Infections

Phase 1

Completed

• Conditions: Soft Tissue Infections; Cellulitis; Abscess
• Interventions: Other: Ultrasound

• Registration Number: NCT01557426
• Lead Sponsor: Rhode Island Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Submitted: 2012-03-15
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-19
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Discharge diagnosis	2 years	Discharge diagnosis will be collected by retrospective chart review

Secondary Outcome Measures

Name	Time	Method
Disposition after admission	2 years

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States