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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Abscess, Methicillin-Resistant Staphylococcus Aureus Infection

Intervention / Treatment
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* Drug: Trim/ Sulfa DS
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bactrim DS<br>Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days | Drug: Trim/ Sulfa DS<br>* bactrim DS (800/160) two tablets PO BID x 7 days<br>* Other names: Bactrim;|
| Placebo Comparator: matched placebo<br>matched placebo 2 pills orally (PO) twice a day (BID) x 7 days | Drug: placebo<br>* matched placebo 2 pills PO BID x 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Rates of Abscesses | Number of patient with a new abscess in same or different location as previous lesion | 30 days after incision and drainage | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abscess, Cellulitis, Antibiotics, MRSA