Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection

59th Medical Wing139 enrolled

Overview

Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) 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) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

139

Conditions

Abscess Methicillin-Resistant Staphylococcus Aureus Infection

Interventions

Trim/ Sulfa DSDRUG

bactrim DS (800/160) two tablets PO BID x 7 days

placeboDRUG

matched placebo 2 pills PO BID x 7 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * All patients age 18-65 who present to the emergency department with a skin abscess that requires incision and drainage. Exclusion Criteria: * Patients with diabetes, HIV, cancer or other immunocompromised patients. * 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 head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded. * Finally, patients with sulfa allergy will be excluded.

Locations (1)

Wilford Hall Medical Center

Lackland Air Force Base, Texas, United States

Outcomes

Primary Outcomes

Recurrence Rates of Abscesses

Number of patient with a new abscess in same or different location as previous lesion

Time frame: 30 days after incision and drainage

Data from ClinicalTrials.gov

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