Prospective Randomized Trial of Bactrim on 7 Day Outcome in Patients With Uncomplicated Abscesses

Last updated: March 1, 2010
Sponsor: Wilford Hall Medical Center
Overall Status: Completed

Phase

3

Condition

Soft Tissue Infections

Skin Wounds

Treatment

N/A

Clinical Study ID

NCT00973765
FWH20080055H_
  • Ages > 16
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Patients will be enrolled in a multi-center study 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) placebo two tablets PO BID X 7 days or 2) bactrim DS (800/160) two tablets PO BID x 7 days. Patients will then return to the emergency department ED) at 48 hours and 7 for wound repacking and evaluation. The primary outcome is treatment failure rates at 7 days after incision and drainage. Patients who are clinically worsening or not improving after 48 hours will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inclusion criteria include all patients age 16 and older who present to the emergencydepartment with a skin abscess that requires incision and drainage.

Exclusion

Exclusion Criteria:

  • Exclusion criteria include patients with diabetes, HIV, cancer or otherimmunocompromised patients.

  • Additionally, any patients who received antibiotics within one week of presentation orwere hospitalized in previous month will be excluded to minimize potential confoundingvariables.

  • Pregnant and breastfeeding patients will also be excluded due to possible safetyconcerns with antibiotic treatment.

  • Patients with abscesses on face, perirectal, or perianal regions, abscesses with knowntracks or fistulas to deeper structures, or abscesses requiring surgical drainage inan operating room are excluded.

  • Patients with fever or evidence of systemic infection

  • Finally, patients with sulfa allergy will be excluded.

Study Design

Total Participants: 212
Study Start date:
November 01, 2007
Estimated Completion Date:
August 31, 2009

Connect with a study center

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas
    United States

    Site Not Available

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