Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage
Information source: Baylor College of Medicine
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abscess
Intervention: oral trimethoprim/sulfamethoxazole (Drug); Placebo (Drug); Observational Unit Short Stay (Other); Hospitalization (Other)
Phase: Phase 3
Status: Completed
Sponsored by: Baylor College of Medicine
Summary
The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm
with antibiotic versus non-antibiotic treatment after incision and drainage. We will also
compare successful rates of cure and time to healing with IV antibiotics and 23-hour
observation unit stay versus hospitalization with IV antibiotics for abscesses greater than
5 cm but less than 10 cm in pediatric patients.
Clinical Details
Official title: Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm and 23 hr Observation Unit to Inpatient Treatment in the Management of Abscesses 5-10cm in the Pediatric Population.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Proportion of patients having abscess resolution to those that do not for each of the treatment modalities employed. For the < 5 cm arm, compare the proportions of patients with successful outcomes between the placebo and TMP/SMX groups.
Secondary outcome: The 5 - 10 cm arm, will compare the proportions of patients with successful outcomes between the 23-hour observation and hospitalization groups.
Eligibility
Minimum age: 90 Days.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Fluctuant abscess on trunk, scalp, extremities and axilla.
Exclusion Criteria:
- Multiple abscesses
- Abscesses greater than 10 cm
- Abscesses located on the hands, face, and perineum
- Bite wounds
- Immunocompromised patients (including diabetes, sickle cell, chronic steroid therapy,
etc.)
- Previously failed 48 hours or greater therapy on any antibiotic regimen
- Abscess less than 5 cm AND patient has (for exclusion criteria 7 - 10):
- Drug allergy to TMP/SMX
- Fever greater than or equal to 102. 2 degrees F in last 24 hours
- Systemic symptoms on presentation - i. e., nausea, vomiting, diaphoresis, etc. \
- Signs/symptoms of another infection or illness - i. e., influenza, croup, etc. Abscess
5 - 10 cm AND patient has (for exclusion criterion 11): \
- Drug allergy to both Clindamycin AND Vancomycin
Locations and Contacts
Texas Children's Hospital, Houston, Texas 77030, United States
Additional Information
Starting date: December 2007
Last updated: December 2, 2010
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