Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections

NCT00595881 | Completed Results

• 1 other identifier: 2007-6-5388
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Abscess

Keywords

Bedside emergency ultrasound; Abscess; Cellulitis; Soft tissue infection; Methicillin resistant staphylococcus aureus (MRSA)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ultrasound

One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.

Device: Bedside emergency ultrasound

Interventions

Bedside emergency ultrasound DEVICE

Ultrasound will be performed on the lesion in question.

Ultrasound

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Marin JR, Dean AJ, Bilker WB, Panebianco NL, Brown NJ, Alpern ER. Emergency ultrasound-assisted examination of skin and soft tissue infections in the pediatric emergency department. Acad Emerg Med. 2013 Jun;20(6):545-53. doi: 10.1111/acem.12148.

  PMID: 23758300 DERIVED

MeSH Terms

Conditions

Abscess; Cellulitis; Soft Tissue Infections

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Infectious; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Potential misclassification of lesions based on reference standard. Biased lesion outcome, as ultrasound results were not incorporated into patient care. Single institution

Results Point of Contact

• Title: Jennifer Marin
• Organization: Children's Hospital of Pittsburgh

jennifer.marin@chp.edu

412-692-7692

Study Officials

• Elizabeth Alpern, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 31, 2012
• Results First Posted: December 27, 2012

Record last verified: 2012-02

Locations

US (1)