Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department

Not Applicable

Terminated

• Conditions: Abscess
• Interventions: Drug: Trimethoprim-sulfamethoxazole; Drug: Sugar pill

• Registration Number: NCT00867789
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

The purpose of this study is to determine if there is a difference between an antibiotic, trimethoprim-sulfamethoxazole versus placebo in healing outcomes of soft tissue abscesses following incision and drainage.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-23
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-24
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2020-08-25
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Results First Posted: 2021-01-26
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Age 3 months to 17 years
• Single, localized soft tissue abscesses requiring incision and drainage with purulent material obtained
• Diameter of the abscess less than 5cm as measured by the treating physician

Exclusion Criteria

• Signs of systemic illness or ill-appearing, as determined by the treating physician
• Admission to the hospital following treatment in the Emergency Department
• Known sulfa allergy
• Immunocompromised patients
• Soft tissue abscesses involving the perineum (labia, scrotum, penis, perirectal)
• Previous antibiotic use (for any reason) in the past seven days
• Non-English speaking patients and families

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trimethoprim-sulfamethaxazole	Trimethoprim-sulfamethoxazole	Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)
Sugar pill	Sugar pill	Incision and drainage of the abscess and treatment with oral placebo (100 patients)

Primary Outcome Measures

Name	Time	Method
Health Outcomes After Use With Trimethoprim-sulfamethaxazole	two years

Trial Locations

Locations (1)

Children's Mercy Hospitals and Clinics; 🇺🇸 Kansas City, Missouri, United States