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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03HS022912-01 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard of care | Active Comparator | Surgeon's routine for preoperative showering. |
|
| antiseptic bundle | Experimental | Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antiseptic bundle | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan E Kline, MD, MPH | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30037355 | Derived | 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. |
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Aggregate data will be reported once the study has been completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Surgeon's routine for preoperative showering. standard of care: Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery. |
| FG001 | Antiseptic Bundle | Patients to use study bundle for 5 days prior to scheduled surgery with the following medications to use at home.
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Antiseptic Bundle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Immediately prior to surgery patients are swabbed again at the 4 body sites to see if SA is present or not. |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care | Used surgeon recommended soap for two pre-op showers, one the night before and one the morning of surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| non-healing wound | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Kline | University of Minnesota | 612-626-3662 | kline003@umn.edu |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| standard of care | Drug | Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery. |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Staphylococcus aureus carriage | Count of Participants | Participants |
|
| STAPHYLOCOCCUS AUREUS TYPE | Count of Participants | Participants |
|
|
|
| 0 |
| 53 |
| 4 |
| 53 |
| 0 |
| 53 |
| EG001 | Antiseptic Bundle | Used three drug antiseptic bundle for 5 days. | 0 | 57 | 10 | 57 | 0 | 57 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| pulmonary embolus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| radial nerve palsy | Nervous system disorders | Non-systematic Assessment |
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| DVT | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| UTI | Renal and urinary disorders | Non-systematic Assessment |
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| bacteremia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| lung collapse | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| subdural hematoma | Nervous system disorders | Non-systematic Assessment |
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| post-op pseudomeningocele | Nervous system disorders | Non-systematic Assessment |
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| thoracic spine fracture post-op | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| uncontrolled post-operative pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Chyle leak | Blood and lymphatic system disorders | Non-systematic Assessment |
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| swallowing difficulties | Gastrointestinal disorders | Non-systematic Assessment |
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| cervical seroma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| gross hematuria | Renal and urinary disorders | Non-systematic Assessment |
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| Clostridium difficile diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |