Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

St. Louis University161 enrolled

Overview

The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.

This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound identified skin abscesses who were not on antibiotics. Patients were block randomized to receive placebo or trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3 days \& a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution with development of new lesion (furuncle, carbuncle or abscess) at a different location. Compliance was evaluated by the return of the study medication or by patient report.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

161

Conditions

Skin Diseases, Infectious

Interventions

Trimethoprim-sulfamethoxazoleDRUG

Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL.

Placebo groupDRUG

Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * non-toxic patients * immunocompetent patients * 3 months to 18 years old * English-speaking patients * skin abscesses * not on antibiotics Exclusion Criteria: * toxic patients * immunocompromising co-morbidities * less than 3 months old or older than 18 years of age * non-english speaking * on antibiotics

Locations (1)

Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Skin Abscess Resolution

Time frame: 10-14 days

Secondary Outcomes

New Lesion Development and Spread of Skin Abscesses (on Subject)

The secondary outcomes of interest included the development of new lesions at a different site (\>5cm away from original skin abscess) on day 10 clinical follow-up or self-report and 3 month telephone follow-up.

Time frame: 10-14 days and 3 month

Data from ClinicalTrials.gov

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