Comparative Effectiveness of Emergency Ultrasound Guided... | NCT02099227

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

NCT02099227

Sponsor

Wake Forest University Health Sciences

Status

Completed

Last Update Posted

Oct 4, 2024Actual

Enrollment

280Actual

Phase

Not provided

Conditions

Soft Tissue Infection

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Mar 26, 2014

First Submission Date that Met QC Criteria

Mar 27, 2014

First Posted Date

Mar 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2024

Last Update Posted Date

Oct 4, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Wake Forest University Health SciencesOTHER

Collaborators

Name	Class
American College of Emergency Physicians	OTHER
Newark Beth Israel Medical Center	OTHER
Baylor College of Medicine	OTHER
UCSF Benioff Children's Hospital Oakland

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

280Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

children presenting to participating pediatric emergency departments

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samuel Lam, MD	advocate christ medical center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Advocate Christ Medical Center		Oak Lawn	Illinois	60453	United States