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

Children's Mercy Hospital Kansas City

Status: Terminated

Conditions: Abscess

Treatments: Drug: Sugar pill; Drug: Trimethoprim-sulfamethoxazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00867789

0810-162

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 3 months to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Trimethoprim-sulfamethaxazole

Experimental group

Description:

Incision and drainage of the abscess and treatment with oral TMP-SMX (100 patients)

Treatment:

Drug: Trimethoprim-sulfamethoxazole

Sugar pill

Placebo Comparator group

Description:

Incision and drainage of the abscess and treatment with oral placebo (100 patients)

Treatment:

Drug: Sugar pill