Prospective Randomized Double Blind, Placebo-Controlled Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection on 30 Day Recurrence Rates.
Overview
- Phase
- Not Applicable
- Intervention
- Trim/ Sulfa DS
- Conditions
- Abscess
- Sponsor
- 59th Medical Wing
- Enrollment
- 139
- Locations
- 1
- Primary Endpoint
- Recurrence Rates of Abscesses
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Gillian Schmitz
Emergency Physician
59th Medical Wing
Eligibility Criteria
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.
Arms & Interventions
Bactrim DS
Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days
Intervention: Trim/ Sulfa DS
matched placebo
matched placebo 2 pills orally (PO) twice a day (BID) x 7 days
Intervention: placebo
Outcomes
Primary Outcomes
Recurrence Rates of Abscesses
Time Frame: 30 days after incision and drainage
Number of patient with a new abscess in same or different location as previous lesion