S. Aureus Screening and Decolonization

NCT02182115 | Completed Phase 4 Results DMC

• 1 other identifier: 1R03HS022912-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Staphylococcus aureus infection; Decolonization; Surgical site infection

Outcome Measures

Primary Outcomes (1)

• Eradication of Staphylococcus Aureus (SA) Carriage at All 4 Body Sites Tested.

  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.

  Immediately prior to surgery patients are swabbed again at the 4 body sites to see if SA is present or not.

Study Arms (2)

standard of care

ACTIVE COMPARATOR

Surgeon's routine for preoperative showering.

Drug: standard of care

antiseptic bundle

EXPERIMENTAL

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

Interventions

antiseptic bundle DRUG

1. Chlorhexidine gluconate liquid soap for bathing daily. 2. Chlorhexidine gluconate mouthrinse to use twice daily. 3. Nasal mupirocin to apply twice daily.

Also known as: Medications applied at home by patient for 5 days.

antiseptic bundle

standard of care DRUG

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

Also known as: Follow surgeon's instructions for pre-operative bathing.

standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• 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.

  PMID: 30037355 DERIVED

MeSH Terms

Conditions

Staphylococcal Infections; Surgical Wound Infection

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Limitations include the small number of participants with methicillin resistant SA (MRSA) and with SA carriage at non-nares sites. We were unable to assess the decolonization bundle's efficacy for MRSA and for sites other than nares and perianal.

Results Point of Contact

• Title: Dr. Susan Kline
• Organization: University of Minnesota

kline003@umn.edu

612-626-3662

Study Officials

• Susan E Kline, MD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 8, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 5, 2019
• Results First Posted: November 17, 2017

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)