Conditions: Abscess
Keywords: abscess Abscesses in the pediatric emergency population
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 23
Healthy volunteers: no

Brief 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)

Arms:
arm 1: subjects with abscesses less than 5cm will be randomized to either study med or placebo arm 2: Placebo after incision and drainage of abscess less than 5 cm.

Interventions: intervention 1: oral trimethoprim/sulfamethoxazole intervention 2: Placebo
Intervention descriptions: intervention 1: 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days intervention 2: Placebo caps or suspension every 12 hours for 10 days

Protocol document: