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Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00595881
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : December 27, 2012
Last Update Posted : December 31, 2012
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief 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.

Condition or disease Intervention/treatment
Abscess Device: Bedside emergency ultrasound

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.

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Study Type : Observational
Actual Enrollment : 420 participants
Time Perspective: Cross-Sectional
Official Title: Emergency Bedside Ultrasound for the Evaluation of Soft Tissue Infections in the Pediatric Emergency Department
Study Start Date : July 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Ultrasound

Group/Cohort Intervention/treatment
One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
Device: Bedside emergency ultrasound
Ultrasound will be performed on the lesion in question.

Primary Outcome Measures :
  1. Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone. [ Time Frame: 18 mos ]
    The sensitivity and specificity of clinical examination with the addition of bedside emergency ultrasound will be compared against that of clinical examination alone.The number of lesions determined to actually have a drainable fluid collection will serve as the denominator in the calculation of sensitivity, and the number of lesions correctly identified as having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator.The number of lesions determined to not have a drainable fluid collection will serve as the denominator in the calculation of specificity, and the number of lesions correctly identified as not having a drainable fluid collection by clinical exam plus ultrasound and clinical exam alone, respectively, will serve as the numerator. Significance will be defined as a 95% confidence interval surrounding the differences between the two groups for sensitivity and specificity that does not include 0.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the emergency department at a tertiary care children's hospital with annual census of 78,000 patients per year.

Inclusion Criteria:

  • Evidence of at least one of the following: skin elevation, induration, tenderness, fluctuance, or history of purulent drainage from the lesion

Exclusion Criteria:

  • Suspected paronychia or felon
  • Lesion involving the face, perirectal, or vaginal area
  • Surgical wound infection
  • Underlying immunodeficiency
  • Non-soft tissue infectious mass (e.g. lymphadenitis)
  • Suspected non-infectious mass (e.g. hernia, lymph node)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00595881

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United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
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Principal Investigator: Elizabeth Alpern, MD, MSCE Children's Hospital of Philadelphia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Children's Hospital of Philadelphia Identifier: NCT00595881    
Other Study ID Numbers: 2007-6-5388
First Posted: January 16, 2008    Key Record Dates
Results First Posted: December 27, 2012
Last Update Posted: December 31, 2012
Last Verified: February 2012
Keywords provided by Children's Hospital of Philadelphia:
Bedside emergency ultrasound
Soft tissue infection
Methicillin resistant staphylococcus aureus (MRSA)
Additional relevant MeSH terms:
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Soft Tissue Infections
Disease Attributes
Pathologic Processes