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

Abscess Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822692
• Other study ID #: FWH20080055H
• Status: Completed
• Phase: N/A
• First received: January 13, 2009
• Last updated: December 17, 2015
• Start date: July 2008
• Est. completion date: June 2009

Study information

• Verified date: December 2015
• Source: Wilford Hall Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscess
• Infection
• Methicillin-Resistant Staphylococcus Aureus Infection
• Staphylococcal Infections

Intervention

Drug:
• Trim/ Sulfa DS
bactrim DS (800/160) two tablets PO BID x 7 days
• placebo
matched placebo 2 pills PO BID x 7 days

Locations

Country	Name	City	State
United States	Wilford Hall Medical Center	Lackland AFB	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Wilford Hall Medical Center	Emergency Medicine Foundation, U.S. Air Force Office of the Surgeon General

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Rates of Abscesses	Number of patient with a new abscess in same or different location as previous lesion	30 days after incision and drainage	No