Clinical trial NCT00822692: Trial of Septra for Uncomplicated Skin Abscesses in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
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 on 30 Day Recurrence Rates.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abscess
Methicillin-Resistant Staphylococcus Aureus Infection
Keywords: Abscess
Cellulitis
Antibiotics
MRSA
Lead sponsor: 59th Medical Wing
Sponsor class: FED
Collaborators: name: U.S. Air Force Office of the Surgeon General
name: Emergency Medicine Foundation
First posted: 2009-01-14
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recurrence Rates of Abscesses
timeFrame: 30 days after incision and drainage
Secondary outcomes:
Other outcomes:
Locations:
city: Lackland AFB
country: United States
facility: Wilford Hall Medical Center
state: Texas
Study officials:
affiliation: 59th Medical Wing
name: Gillian R Schmitz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmitz GR, Bruner D, Pitotti R, Olderog C, Livengood T, Williams J, Huebner K, Lightfoot J, Ritz B, Bates C, Schmitz M, Mete M, Deye G. Randomized controlled trial of trimethoprim-sulfamethoxazole for uncomplicated skin abscesses in patients at risk for community-associated methicillin-resistant Staphylococcus aureus infection. Ann Emerg Med. 2010 Sep;56(3):283-7. doi: 10.1016/j.annemergmed.2010.03.002. Epub 2010 Mar 26.