Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections

NCT ID: NCT00595881

Last Updated: 2012-12-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 420 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-05-31

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.

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.

Conditions

Abscess

Keywords

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

Study Design

• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Ultrasound

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

Bedside emergency ultrasound

Intervention Type: DEVICE

Ultrasound will be performed on the lesion in question.

Interventions

Bedside emergency ultrasound

Ultrasound will be performed on the lesion in question.

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Alpern, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23758300 (View on PubMed)

Other Identifiers

2007-6-5388

Identifier Type: -

Identifier Source: org_study_id