NCT02099227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 4, 2024

Status Verified

September 1, 2016

Enrollment Period

1.5 years

First QC Date

March 26, 2014

Last Update Submit

October 2, 2024

Conditions

Soft Tissue Infection

Keywords

pediatricsoft tissue infectionsultrasonographyeffectiveness

Outcome Measures

Primary Outcomes (1)

  • treatment failure rate

    unscheduled return visits need for subsequent procedural intervention need for subsequent admission change in therapy

    7-10days

Secondary Outcomes (1)

  • emergency department process outcome

    7-10days

Study Arms (2)

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

Eligibility Criteria

Age6 Months - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children presenting to participating pediatric emergency departments

You may qualify if:

  • history and examination findings consistent with possible abscess or cellulitis per the treating clinician.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

MeSH Terms

Conditions

Soft Tissue Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Samuel Lam, MD

    advocate christ medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2014

First Posted

March 28, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 4, 2024

Record last verified: 2016-09

Locations

US(1)