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

Not Applicable

Completed

• Conditions: Methicillin-Resistant Staphylococcus Aureus Infection; Abscess
• Interventions: Drug: Trim/ Sulfa DS; Drug: placebo

• Registration Number: NCT00822692
• Lead Sponsor: 59th Medical Wing

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2009-07-29
• Results First Submitted QC: 2009-07-29
• Results First Posted: 2009-09-03
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bactrim DS	Trim/ Sulfa DS	Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days
matched placebo	placebo	matched placebo 2 pills orally (PO) twice a day (BID) x 7 days

Primary Outcome Measures

Name	Time	Method
Recurrence Rates of Abscesses	30 days after incision and drainage	Number of patient with a new abscess in same or different location as previous lesion

Trial Locations

Locations (1)

Wilford Hall Medical Center; 🇺🇸 Lackland AFB, Texas, United States