Philadelphia, Pennsylvania 19104


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.


Study summary:

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.


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)


Study is Available At:


Original ID:

2007-6-5388


NCT ID:

NCT00595881


Secondary ID:


Study Acronym:


Brief Title:

Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

2 Months


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital of Philadelphia


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Cross-Sectional


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

750


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Elizabeth Alpern, MD, MSCE
Principal Investigator
Children's Hospital of Philadelphia
Primary Contact:Jennifer Marin, MD
215-590-1970
marinj@email.chop.edu
Backup Contact:Elizabeth Alpern, MD, MSCE
215-590-1944
alpern@email.chop.edu

Study Dates

Start Date:July 2008
Completion Date:March 2010
Completion Type:Anticipated
Primary Completion Date:March 2010
Primary Completion Type:Anticipated
Verification Date:January 2010
Last Changed Date:January 8, 2010
First Received Date:January 7, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Prevalence of abscess and methicillin resistant Staphylococcus aureus as a causative agent
Time Frame:18 mos
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Sensitivity of bedside ultrasound when added to the clinical examination
Time Frame:18 mos
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Bedside emergency ultrasound
Description:Ultrasound will be performed on the lesion in question.
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1
Description:One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital of Philadelphia

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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