NCT01820455

MRSA in a Trauma Population: Does Decolonization Prevent Infection?

Methicillin-resistant Staphylococcus Aureus in a Trauma Population: Does Decolonization Prevent Infection?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University of Tennessee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

All trauma patients admitted to certain Intensive Care Units (ICU) will have Methicillin-resistant Staphylococcus aureus (MRSA) nasal swabs performed to determine MRSA colonization status. Only those patients who are determined to be colonized with MRSA at admission will be included in the study. All patients must be age 18 and older, admitted directly to the ICU from either the Emergency Department or the operating room with trauma-related injuries, and must not have active or recent known history of MRSA infections. Once patients have been determined to be colonized with MRSA, they will be randomized to receive "decolonization" treatment or placebo. "Decolonization" treatment will include Chlorhexidine baths and Mupirocin ointment to both nares for 5 days and placebo will entail "routine" soap baths and Lubricating Jelly. Both groups will be kept on standard contact precautions throughout the course of the study. Repeat nasal swabs will be performed at the completion of the treatment regimen to determine the efficacy. Patients will be screened for invasive MRSA infections as dictated by their clinical course. The primary outcome measure will be invasive MRSA infection rate (pneumonia, urinary tract infection, bacteremia and soft tissue infection). Secondary endpoints include hospital lengths of stay, ICU lengths of stay, mechanical ventilatory support requirements, colonization status at the end of treatment, and death rates. As determined by our power analysis, we aim to enroll 75 patients in each arm over the course of 12-24 months.

Detailed description

Partway through the enrollment period, it was determined that in the best interests of the patients, the protocol would be altered to eliminate the randomization process and treat all patients with the decolonization treatment regimen.

Conditions

• MRSA Colonization

Interventions

Type	Name	Description
DRUG	Chlorhexidine, Mupirocin	Chlorhexidine baths and intranasal mupirocin ointment once daily for five days
DRUG	Soap baths, Lubricating Jelly	Soap and water baths with lubricating jelly to the nares, once daily for 5 days

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-01-01
• Completion: 2014-03-01
• First posted: 2013-03-28
• Last updated: 2014-12-18

Locations

1 site across 1 country: United States