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Sponsored by: |
Children's Hospital of Philadelphia |
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Information provided by: | Children's Hospital of Philadelphia |
ClinicalTrials.gov Identifier: | NCT00595881 |
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.
Condition | Intervention |
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Abscess |
Device: Bedside emergency ultrasound |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Emergency Bedside Ultrasound for the Evaluation of Soft Tissue Infections in the Pediatric Emergency Department |
Estimated Enrollment: | 375 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
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Device: Bedside emergency ultrasound
Ultrasound will be performed on the lesion in question.
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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.
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. The primary goal of this study is to evaluate the test characteristics of EUS in pediatric patients presenting with evidence of soft tissue infection. Secondary aims include evaluating the prevalence of soft tissue abscesses and MRSA infections specifically in the study population.
Ages Eligible for Study: | 2 Months to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Marin, MD | 215-590-1970 | marinj@email.chop.edu |
Contact: Elizabeth Alpern, MD, MSCE | 215-590-1944 | alpern@email.chop.edu |
United States, Pennsylvania | |
The Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Elizabeth Alpern, MD, MSCE | Children's Hospital of Philadelphia |
Responsible Party: | The Children's Hospital of Philadelphia ( Elizabeth Alpern, MD, MSCE/ Assistant Professor of Pediatrics ) |
Study ID Numbers: | 2007-6-5388 |
Study First Received: | January 7, 2008 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00595881 |
Health Authority: | United States: Institutional Review Board |
Bedside emergency ultrasound Abscess Cellulitis Soft tissue infection Methicillin resistant staphylococcus aureus (MRSA) |
Cellulitis Methicillin Soft Tissue Infections Abscess |
Suppuration Emergencies Inflammation |
Disease Attributes Pathologic Processes Infection |