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

NCT ID: NCT02099227

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Soft Tissue Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ultrasound

those who received point-of-care ultrasound as part of their emergency department evaluation/ treatment for suspected soft tissue infections

No interventions assigned to this group

No Ultrasound

those who did not receive point-of-care ultrasound as part of their emergency department evaluation/ treatment for suspected soft tissue infections

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American College of Emergency Physicians

OTHER

Sponsor Role collaborator

Newark Beth Israel Medical Center

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role collaborator

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role collaborator

Maimonides Medical Center

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Lam, MD

Role: PRINCIPAL_INVESTIGATOR

advocate christ medical center

Locations

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Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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AHC IRB 5577

Identifier Type: -

Identifier Source: org_study_id

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