Soft Tissue Ultrasound of Infections

NCT01557426 | Completed Phase 1

• 1 other identifier: 304321
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Infections; Cellulitis; Abscess

Keywords

skin; soft tissue; infection; cellulitis; abscess

Outcome Measures

Primary Outcomes (1)

• Discharge diagnosis

  Discharge diagnosis will be collected by retrospective chart review

  2 years

Secondary Outcomes (1)

• Disposition after admission

  2 years

Study Arms (1)

Ultrasound

OTHER

Single interventional group - patients agree to an ultrasound of their skin or soft tissue infection and an ultrasound to an uninfected portion of skin.

Other: Ultrasound

Interventions

Ultrasound OTHER

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.

Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients in custody of law enforcement
• Patients on a psychiatric hold

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Soft Tissue Infections; Cellulitis; Abscess; Infections

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Otto Liebmann, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 19, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 29, 2015

Record last verified: 2012-03

Locations

US (1)