Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00595881
First received: January 7, 2008
Last updated: December 27, 2012
Last verified: February 2012
  Purpose

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 Intervention
Abscess
Device: Bedside emergency ultrasound

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Emergency Bedside Ultrasound for the Evaluation of Soft Tissue Infections in the Pediatric Emergency Department

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone. [ Time Frame: 18 mos ] [ Designated as safety issue: No ]
    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.


Enrollment: 420
Study Start Date: July 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ultrasound
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.

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.

  Eligibility

Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595881

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Elizabeth Alpern, MD, MSCE Children's Hospital of Philadelphia
  More Information

No publications provided by Children's Hospital of Philadelphia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00595881     History of Changes
Other Study ID Numbers: 2007-6-5388
Study First Received: January 7, 2008
Results First Received: July 13, 2011
Last Updated: December 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Bedside emergency ultrasound
Abscess
Cellulitis
Soft tissue infection
Methicillin resistant staphylococcus aureus (MRSA)

Additional relevant MeSH terms:
Abscess
Emergencies
Soft Tissue Infections
Suppuration
Infection
Inflammation
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on April 23, 2014