Comparative Effectiveness of Emergency Ultrasound Guided Management of Pediatric Soft Tissue Infections

September 8, 2016 updated by: May Alrahi
To examine the effect of Point-of-Care Ultrasound (POCUS) management guidance on pediatric skin and soft tissue infections treatment failure rate, as well as emergency department process outcome.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children presenting to participating pediatric emergency departments

Description

Inclusion Criteria:

  • history and examination findings consistent with possible abscess or cellulitis per the treating clinician.
  • minimal lesion diameter for inclusion is 1cm.

Exclusion Criteria:

  • suspected soft tissue infections involving or near mucosal membranes (e.g. perirectal, peritonsillar, vulvovaginal areas)
  • facial lesions
  • paronychia or felon
  • parent or patient refusal of consent
  • unsuitable subjects deemed by treating clinicians.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Ultrasound
those who received point-of-care ultrasound as part of their emergency department evaluation/ treatment for suspected soft tissue infections
No Ultrasound
those who did not receive point-of-care ultrasound as part of their emergency department evaluation/ treatment for suspected soft tissue infections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment failure rate
Time Frame: 7-10days
unscheduled return visits need for subsequent procedural intervention need for subsequent admission change in therapy
7-10days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
emergency department process outcome
Time Frame: 7-10days
emergency department (ED) length of stay, need for ED procedural sedation use of alternative imaging in ED
7-10days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

May Alrahi

Collaborators

Baylor College of Medicine
Montefiore Medical Center
Maimonides Medical Center
UCSF Benioff Children's Hospital Oakland
American College of Emergency Physicians
Newark Beth Israel Medical Center

Investigators

  • Principal Investigator: Samuel Lam, MD, Advocate Christ Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

March 27, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHC IRB 5577

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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