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S. Aureus Screening and Decolonization

Effectiveness of Screening and Decolonization of S. Aureus in Surgery Outpatients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02182115
Enrollment
110
Registered
2014-07-08
Start date
2014-07-31
Completion date
2016-08-31
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Staphylococcus aureus infection, Decolonization, Surgical site infection

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.

Interventions

DRUGantiseptic bundle

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

DRUGstandard of care

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

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard of Care
Surgeon's routine for preoperative showering. 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.
53
Antiseptic Bundle
Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home. Chlorhexidine gluconate soap applied for bathing daily. Chlorhexidine gluconate mouthrinse used to rinse mouth twice daily. Nasal mupirocin to applied inside nostrils twice daily.
57
Total110

Baseline characteristics

CharacteristicStandard of CareAntiseptic BundleTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
12 Participants18 Participants30 Participants
Age, Categorical
Between 18 and 65 years
41 Participants39 Participants80 Participants
Age, Continuous52.5 years
STANDARD_DEVIATION 13.1
58.8 years
STANDARD_DEVIATION 13.3
55.8 years
STANDARD_DEVIATION 13.5
Race/Ethnicity, Customized
Other racial/ethnic groups
8 Participants3 Participants11 Participants
Race/Ethnicity, Customized
Unknown or incomplete racial/ethnic group
1 Participants3 Participants4 Participants
Race/Ethnicity, Customized
White
44 Participants51 Participants95 Participants
Sex: Female, Male
Female
22 Participants31 Participants53 Participants
Sex: Female, Male
Male
31 Participants26 Participants57 Participants
Staphylococcus aureus carriage53 Participants57 Participants110 Participants
STAPHYLOCOCCUS AUREUS TYPE
Methicillin resistant Staphylococcus aureus (MRSA)
5 Participants6 Participants11 Participants
STAPHYLOCOCCUS AUREUS TYPE
Methicillin sensitive Staphylococcus aureus (MSSA)
48 Participants51 Participants99 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 530 / 57
other
Total, other adverse events
0 / 530 / 57
serious
Total, serious adverse events
4 / 5310 / 57

Outcome results

Primary

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.

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Standard of CareEradication of Staphylococcus Aureus (SA) Carriage at All 4 Body Sites Tested.13 Participants
Antiseptic BundleEradication of Staphylococcus Aureus (SA) Carriage at All 4 Body Sites Tested.41 Participants

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026