S. Aureus Screening and Decolonization

NCT ID: NCT02182115

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-08-31

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.

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.

Conditions

Wound Infection Due to Staphylococcus Aureus; MRSA Infection of Postoperative Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard of care

Surgeon's routine for preoperative showering.

Group Type: ACTIVE_COMPARATOR

standard of care

Intervention Type: DRUG

Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.

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.

Group Type: EXPERIMENTAL

antiseptic bundle

Intervention Type: DRUG

1. Chlorhexidine gluconate liquid soap for bathing daily.

2. Chlorhexidine gluconate mouthrinse to use twice daily.

3. Nasal mupirocin to apply twice daily.

Interventions

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.

Intervention Type: DRUG

standard of care

Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.

Intervention Type: DRUG

Other Intervention Names

Medications applied at home by patient for 5 days.; Follow surgeon's instructions for pre-operative bathing.

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan E Kline, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Countries

United States

References

Kline SE, Neaton JD, Lynfield R, Ferrieri P, Kulasingam S, Dittes K, Glennen A, Jawahir S, Kaizer A, Menk J, Johnson JR. Randomized controlled trial of a self-administered five-day antiseptic bundle versus usual disinfectant soap showers for preoperative eradication of Staphylococcus aureus colonization. Infect Control Hosp Epidemiol. 2018 Sep;39(9):1049-1057. doi: 10.1017/ice.2018.151. Epub 2018 Jul 24.

Reference Type: DERIVED

PMID: 30037355 (View on PubMed)

Other Identifiers

1R03HS022912-01

Identifier Type: AHRQ

Identifier Source: secondary_id

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1R03HS022912-01

Identifier Type: AHRQ

Identifier Source: org_study_id

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