Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections

Abscess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595881
• Other study ID #: 2007-6-5388
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: December 27, 2012
• Start date: July 2008
• Est. completion date: May 2010

Study information

• Verified date: February 2012
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 18 Years

Eligibility

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)

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Abscess
• Emergencies
• Soft Tissue Infections

Intervention

Device:
• Bedside emergency ultrasound
Ultrasound will be performed on the lesion in question.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone.	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.	18 mos	No