Clinical trial NCT00867789: Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department
Official title: Trimethoprim-sulfamethoxazole Versus Placebo in the Treatment of Cutaneous Abscesses in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abscess
Keywords: abscess
outcomes
antibiotics
incision and drainage
skin abscess
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield
First posted: 2009-03-24
Enrollment: 140
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Health Outcomes After Use With Trimethoprim-sulfamethaxazole
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Joan E Giovanni, MD
role: PRINCIPAL_INVESTIGATOR
References:
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