Prospective Randomized Trial of Bactrim on 7 Day Outcome in Patients With Uncomplicated Abscesses

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-08-31

Brief Summary

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Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) placebo two tablets PO BID X 7 days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary outcome is treatment failure rates at 7 days after incision and drainage. Patients who are clinically worsening or not improving after 48 hours will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat.

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Detailed Description

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Conditions

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Abscesses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bactrim DS (800/160) 2 pills po BID x 7 days

active comparator

Group Type ACTIVE_COMPARATOR

bactrim

Intervention Type DRUG

bactrim DS (800/160) 2 pills PO BID x 7 days

Matched placebo 2 pills po BID x 7 days

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo 2 pills po BID x 7 days

Interventions

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bactrim

bactrim DS (800/160) 2 pills PO BID x 7 days

Intervention Type DRUG

placebo

placebo 2 pills po BID x 7 days

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Additionally, any patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables.
* Pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment.
* Patients with abscesses on face, perirectal, or perianal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
* Patients with fever or evidence of systemic infection
* Finally, patients with sulfa allergy will be excluded.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes