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Completed

NCT Number: NCT00822692

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trim/ Sulfa DS

Drug

bactrim DS (800/160) two tablets PO BID x 7 days

Other names: Bactrim

Placebo

Drug

matched placebo 2 pills PO BID x 7 days

Primary outcomes

  1. Recurrence Rates of Abscesses

    Time frame: 30 days after incision and drainage

    Number of patient with a new abscess in same or different location as previous lesion

Sponsors and collaborators

Lead sponsor

59th Medical Wing

Fed

Collaborators

  • Emergency Medicine Foundation
  • U.S. Air Force Office of the Surgeon General

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 14, 2009
Registry last updated
Dec 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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