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

Soft Tissue Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099227
• Other study ID #: AHC IRB 5577
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: September 8, 2016
• Start date: March 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 19 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Emergencies
• Infection
• Soft Tissue Infection
• Soft Tissue Infections

Locations

Country	Name	City	State
United States	Advocate Christ Medical Center	Oak Lawn	Illinois

Sponsors (7)

Lead Sponsor	Collaborator
May Alrahi	American College of Emergency Physicians, Children's Hospital & Research Center Oakland, Maimonides Medical Center, Montefiore Medical Center, Newark Beth Israel Medical Center, Texas Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment failure rate	unscheduled return visits need for subsequent procedural intervention need for subsequent admission change in therapy	7-10days	No
Secondary	emergency department process outcome	emergency department (ED) length of stay, need for ED procedural sedation use of alternative imaging in ED	7-10days	No