Clinical Trials Directory

Trials / Completed

CompletedNCT00595881

Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections

Emergency Bedside Ultrasound for the Evaluation of Soft Tissue Infections in the Pediatric Emergency Department

Status
Completed
Phase
Study type
Observational
Enrollment
420 (actual)
Sponsor
Children's Hospital of Philadelphia · Academic / Other
Sex
All
Age
2 Months – 18 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to determine if soft tissue infections in pediatric patients can be more accurately diagnosed (i.e. the presence of a drainable abscess) with the addition of bedside ultrasound to the clinical examination compared to the clinical examination alone.

Detailed description

Skin and soft tissue infections, particularly abscesses caused by community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA) are a growing public health problem. The treatment of a skin abscess usually requires incision and drainage or needle aspiration. In addition to providing definitive therapy, appropriate drainage can allow for organism identification and antibiotic susceptibility testing should antibiotics be utilized. A skin cellulitis, which is treated with systemic antibiotics and supportive care alone, may be hard to distinguish from an abscess, as both have similar clinical features. Therefore, as the presence or absence of purulent material may be difficult to determine, children may undergo an unnecessary drainage procedure. If drainage is avoided, the patient may require a subsequent ED visit if the diagnosis is missed on initial examination. This can lead to worsened clinical outcome, an extra financial burden for the family, and added emotional distress for the patient. Bedside emergency ultrasound (EUS), which has been used since the mid-1980s is being used in adults to detect fluid collections such as soft tissue abscesses. Studies in adult patients have shown that EUS adds useful information to the history and physical examination and may even alter physicians' clinical impressions and management of patients. Currently, it is not known whether children represent a different population for EUS than adults and how EUS would perform in the pediatric outpatient setting. With improved diagnosis of soft tissue infections, better epidemiologic data about organism prevalence, improved and more prompt treatment, and more appropriate use of antibiotic therapy can be done. To date, no study exists evaluating its utility specifically for the evaluation of soft tissue infections in pediatric patients. The goal of this study is to evaluate the test characteristics of EUS in pediatric patients presenting with evidence of soft tissue infection.

Conditions

Interventions

TypeNameDescription
DEVICEBedside emergency ultrasoundUltrasound will be performed on the lesion in question.

Timeline

Start date
2008-07-01
Primary completion
2010-05-01
Completion
2010-05-01
First posted
2008-01-16
Last updated
2012-12-31
Results posted
2012-12-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00595881. Inclusion in this directory is not an endorsement.