NCT00691600

Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage

Phase 3 Study Comparing Bactrim to Placebo in the Management of Abscesses < 5cm in the Pediatric Population.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 90 Days – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare rates of cure of abscesses with and without antibiotic treatment after incision and drainage. The purpose of this study is to compare successful rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus non-antibiotic treatment after incision and drainage.

Detailed description

This study is a randomized controlled trial of antibiotic treatment versus placebo after incision and drainage of skin and soft tissue abscesses less than 5 cm in pediatric patients. Eligible patients whose parents/guardians consented them to enrollment were randomized to receive one of two interventions: oral trimethoprim/sulfamethoxazole (TMP/SMX) or placebo after incision and drainage. Every attempt was made to make the placebo capsules and suspensions appear in all aspects like the true drug (was done by the investigational pharmacy department at our institution). Equal numbers of subjects were randomized at the outset to both study groups. Randomization, also done by our investigational pharmacy department, was done in blocks of 20. Patients were followed up in our emergency center at 24 to 48 hours to have any packing removed and to have their clinical/wound status assessed. They were not charged for this visit, and their valet parking was validated. If an individual patient, or an individual patient's wound, was felt to be not improving adequately, that patient was started on formal antibiotic therapy at the treating attending physician's discretion. Primary outcome: 1\. Abscess resolution by parental report 7-10 days after incision and drainage Secondary outcomes: 1. Admission to the hospital because of worsening infection 2. Receipt of antibiotics (placebo arm) or change in antibiotics (antibiotic arm)

Conditions

• Abscess

Interventions

Type	Name	Description
DRUG	oral trimethoprim/sulfamethoxazole	80 mg caps or 8 mg/ml suspension every 12 hours for 10 days
DRUG	Placebo	Placebo caps or suspension every 12 hours for 10 days

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-06-05
• Last updated: 2020-07-01
• Results posted: 2020-06-23

Locations

1 site across 1 country: United States