Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections
This study is currently recruiting participants.
Verified by Children's Hospital of Philadelphia, July 2008
Sponsored by: Children's Hospital of Philadelphia
Information provided by: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00595881
  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.


Condition Intervention
Abscess
Device: Bedside emergency ultrasound

MedlinePlus related topics: Ultrasound
Drug Information available for: Methicillin Methicillin sodium
U.S. FDA Resources
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

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

Primary Outcome Measures:
  • Sensitivity of bedside ultrasound when added to the clinical examination [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevalence of abscess and methicillin resistant Staphylococcus aureus as a causative agent [ Time Frame: one year ] [ Designated as safety issue: No ]

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
1: Experimental
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.

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.

  Eligibility

Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Contacts
Contact: Jennifer Marin, MD 215-590-1970 marinj@email.chop.edu
Contact: Elizabeth Alpern, MD, MSCE 215-590-1944 alpern@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia Recruiting
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

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

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

Study placed in the following topic categories:
Cellulitis
Methicillin
Soft Tissue Infections
Abscess
Suppuration
Emergencies
Inflammation

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009