An observational study in Abscess, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 2 Months to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-12-31.
Sponsored by Children's Hospital of Philadelphia · Observational
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 420 is above the median of 240 across 2,136 observational studies indexed under Infections.
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Patients will be recruited from the emergency department at a tertiary care children's hospital with annual census of 78,000 patients per year.
Exclusion Criteria:
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.
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.
Time frame: 18 mos
Patients were recruited over a 22 month period
| Milestone | Ultrasound |
|---|---|
| Started | 420 |
| Completed | 420 |
| Not completed | 0 |
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.
| Ratio as a percentage | Clinical Exam Alone | Clinical Exam+ Ultrasound |
|---|---|---|
| Sensitivity | 94.7 (90.2 to 97.9) | 93.1 (88.6 to 97.0) |
| Specificity | 84.2 (74.7 to 91.7) | 81.4 (70.8 to 90.3) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ultrasound | — | 0/420 (0%) | 0/420 (0%) |
| Age, Categorical(Participants) | Ultrasound |
|---|---|
| <=18 years | 420 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age Continuous(years) | Ultrasound |
|---|---|
| Mean | 7.8 ± 6 |
| Sex: Female, Male(Participants) | Ultrasound |
|---|---|
| Female | 218 |
| Male | 202 |
| Region of Enrollment(participants) | Ultrasound |
|---|---|
| United States | 420 |
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia