Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00973765
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : March 2, 2010
Last Update Posted : March 9, 2010
Emergency Medicine Foundation
Information provided by:
59th Medical Wing

Brief 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.

Condition or disease Intervention/treatment Phase
Abscesses Drug: bactrim Drug: placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Placebo-Controlled Trial of Bactrim on 7 Day Outcome in Emergency Department Patients With Uncomplicated Abscesses at Risk for Community Acquired Methicillin Resistant Staph Aureus
Study Start Date : November 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arm Intervention/treatment
Active Comparator: bactrim DS (800/160) 2 pills po BID x 7 days
active comparator
Drug: bactrim
bactrim DS (800/160) 2 pills PO BID x 7 days

Placebo Comparator: Matched placebo 2 pills po BID x 7 days
Drug: placebo
placebo 2 pills po BID x 7 days

Primary Outcome Measures :
  1. Treatment Failures at 7 Days [ Time Frame: 7 days ]
    worsening abscess or new recurrence of abscess

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Exclusion criteria include 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 face, perirectal, or perianal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded.
  • Patients with fever or evidence of systemic infection
  • Finally, patients with sulfa allergy will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00973765

Layout table for location information
United States, Texas
Wilford Hall Medical Center
Lackland Air Force Base, Texas, United States
Sponsors and Collaborators
59th Medical Wing
Emergency Medicine Foundation
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gillian Schmitz, MD, Wilford Hall Medical Center Identifier: NCT00973765    
Other Study ID Numbers: FWH20080055H_
First Posted: September 9, 2009    Key Record Dates
Results First Posted: March 2, 2010
Last Update Posted: March 9, 2010
Last Verified: September 2009
Keywords provided by 59th Medical Wing:
uncomplicated abscesses
Additional relevant MeSH terms:
Layout table for MeSH terms
Pathologic Processes
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents