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S. Aureus Screening and Decolonization

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.
 
ClinicalTrials.gov Identifier: NCT02182115
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : November 17, 2017
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
Staphylococcus aureus (SA) healthcare-associated infections (HAI) cause significant morbidity and mortality. SA causes 15% of all HAI and 30% of surgical site infections (SSIs). Each year over 40 million Americans undergo operations, 1-10% of whom will acquire SSIs. Such infections double the length of hospitalization and risk of dying, and increase U.S. health care costs by $5-10 billion/year. We need effective interventions to prevent SSIs caused by either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) strains. Nasal carriers of SA (25-30% of adults) have a 2-14 times greater risk than non-carriers of acquiring an SA SSI. A potential prevention approach is routine pre-operative screening of patients, followed by decolonization of identified SA carriers.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

  1. Chlorhexidine gluconate soap applied for bathing daily.
  2. Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily.
  3. Nasal mupirocin to applied inside nostrils twice daily.
Drug: antiseptic bundle
  1. Chlorhexidine gluconate liquid soap for bathing daily.
  2. Chlorhexidine gluconate mouthrinse to use twice daily.
  3. Nasal mupirocin to apply twice daily.
Other Name: Medications applied at home by patient for 5 days.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patient who are 18 years and older, able to give informed consent and willing to complete the study decolonization protocol.
  • Surgery must be scheduled 2 weeks in the future to allow completion of the study protocol prior to the scheduled operation.
  • Patients will be admitted from home the day of the surgery or have the surgery done on an outpatient basis.

Exclusion Criteria:

  • Currently on antibiotic therapy, allergy to mupirocin or CHG.

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 ClinicalTrials.gov identifier (NCT number): NCT02182115


Locations
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United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Susan E Kline, MD, MPH University of Minnesota

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02182115    
Other Study ID Numbers: 1R03HS022912-01 ( U.S. AHRQ Grant/Contract )
1R03HS022912-01 ( U.S. AHRQ Grant/Contract )
First Posted: July 8, 2014    Key Record Dates
Results First Posted: November 17, 2017
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate data will be reported once the study has been completed.
Keywords provided by University of Minnesota:
Staphylococcus aureus infection
Decolonization
Surgical site infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wound Infection
Wounds and Injuries
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents