Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
Information source: Wilford Hall Medical Center
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abscess; Methicillin-Resistant Staphylococcus Aureus Infection
Intervention: Septra DS (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Wilford Hall Medical Center Official(s) and/or principal investigator(s):
Gillian R Schmitz, Principal Investigator, Affiliation: Wilford Hall Medical Center
Overall contact:
Gillian R Schmitz, M.D., Phone: 919-724-9185, Email: gillianmd@gmail.com
Summary
Patients will be enrolled in a multi-center study (WHMC and BAMC) 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) septra DS two pills
PO BID x 7 days or 2)placebo. Patients will then return to the ER on days 3 and 7 for wound
repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after
incision and drainage and 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.
Clinical Details
Official title: 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.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: The primary outcome is clinical cure of abscess at 7 days
Secondary outcome: Secondary outcome is recurrence rates of abscesses at 30 days.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All patients age 18-55 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 and Contacts
Gillian R Schmitz, M.D., Phone: 919-724-9185, Email: gillianmd@gmail.com
Wilford Hall Medical Center, Lackland AFB, Texas 78236, United States; Recruiting
Gillian R Schmitz, Phone: 919-724-9185, Email: gillianmd@gmail.com
Gillian R Schmitz, MD, Principal Investigator
Additional Information
Starting date: April 2008
Ending date: June 2009
Last updated: January 13, 2009
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