S. Aureus Screening and Decolonization
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|ClinicalTrials.gov Identifier: NCT02182115|
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : November 17, 2017
Last Update Posted : November 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Wound Infection Due to Staphylococcus Aureus MRSA Infection of Postoperative Wound||Drug: antiseptic bundle Drug: standard of care||Phase 4|
The long term goal of this research is to help reduce the incidence of SSIs caused by SA, both MSSA and MRSA strains. This will help improve the safety and effectiveness of health care for Americans. Achievement of this goal requires that we first address the following critical knowledge gaps: (i) which surgical patients should be screened pre-operatively; (ii) which body site(s) should be screened for optimal SA detection, and (iii) which decolonization approach is optimal for outpatient use. The goal of this study is to conduct the research needed to determine pre-operative SA carriage rates (including by strain type and site of carriage), to evaluate the practicality (adherence, cost) of a SA decolonization protocol that is self-administered by patients at home. We are conducting randomized clinical trial (RCT) of the efficacy of nasal mupirocin ointment, chlorhexidine gluconate (CHG) mouth rinse, and CHG pre-operative bathing, as performed by the patient at home for 5 days pre-operatively. This protocol will be compared with the current standard of care, usually 1-2 showers with an antiseptic soap before the procedure. Briefly, the aims are as follows:
Aim 1: Determine the efficacy of a novel decolonization protocol, compared with standard of care, for eradicating SA carriage pre-operatively in surgery out-patients. We hypothesize that the SA eradication rate will be 2-3 times higher in the intervention arm compared with the standard of care arm.
Aim 2: Obtain data to inform sample size calculations and cost estimates for a future trial to prevent SSIs, determine screening requirements, and assess treatment adherence. We will: determine the proportion of pre-operative patients who are SA carriers and the sites of carriage, by SA type, determine adherence to the study intervention and standard of care, reasons for non-compliance, and gather cost data to provide preliminary evidence of potential cost-effectiveness of the intervention.
Aim 3: Identify risk factors (demographic, medical) for SA carriage. Gather preliminary data on SSIs in study subjects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Screening and Decolonization of S. Aureus in Surgery Outpatients|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Active Comparator: standard of care
Surgeon's routine for preoperative showering.
Drug: standard of care
Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.
Other Name: Follow surgeon's instructions for pre-operative bathing.
Experimental: antiseptic bundle
Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.
Drug: antiseptic bundle
Other Name: Medications applied at home by patient for 5 days.
- Eradication of Staphylococcus Aureus (SA) Carriage at All 4 Body Sites Tested. [ Time Frame: Immediately prior to surgery patients are swabbed again at the 4 body sites to see if SA is present or not. ]Participants with no SA post-treatment, proportion (%) of participants in each study arm that had no SA detected on the post-treatment cultures from the 4 body sites sampled with swab cultures.
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 ClinicalTrials.gov identifier (NCT number): NCT02182115
|United States, Minnesota|
|University of Minnesota Medical Center|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Susan E Kline, MD, MPH||University of Minnesota|