Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

Phase 4

Completed

• Conditions: Skin Diseases, Infectious
• Interventions: Drug: Placebo group; Drug: Trimethoprim-sulfamethoxazole

• Registration Number: NCT00679302
• Lead Sponsor: St. Louis University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2006-07
• Primary Completion: 2008-02
• Study Completion: 2008-05
• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-16
• Results First Submitted: 2013-01-29
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-28
• Results First Posted: 2014-04-29
• Last Update Submitted: 2018-04-02
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo group	Maalox and bitter mixture
antibiotic group	Trimethoprim-sulfamethoxazole	Trimethoprim-sulfamethoxazole suspension

Primary Outcome Measures

Name	Time	Method
Skin Abscess Resolution	10-14 days

Secondary Outcome Measures

Name	Time	Method
New Lesion Development and Spread of Skin Abscesses (on Subject)	10-14 days and 3 month	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.

Trial Locations

Locations (1)

Cardinal Glennon Children's Medical Center; 🇺🇸 Saint Louis, Missouri, United States