<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02216227</url>
  </required_header>
  <id_info>
    <org_study_id>CRE 12-291</org_study_id>
    <nct_id>NCT02216227</nct_id>
  </id_info>
  <brief_title>Checklist to Prevent MRSA Surgical Site Infections</brief_title>
  <official_title>Checklist to Prevent MRSA Surgical Site Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of this project are 1) to assess the effectiveness and cost-effectiveness of the&#xD;
      checklist to prevent MRSA SSIs among Veterans undergoing TJA or cardiac surgery, and 2) to&#xD;
      assess barriers and facilitators to checklist implementation.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. The SSI checklist will be effective at reducing MRSA SSIs among total joint arthroplasty&#xD;
           and cardiac surgery patients.&#xD;
&#xD;
        2. Implementation of the checklist will be associated with an overall reduction in SSIs&#xD;
           caused by all pathogens.&#xD;
&#xD;
        3. The SSI Checklist will be cost-saving since it will prevent many expensive SSIs.&#xD;
&#xD;
        4. Preoperative MRSA testing will be a modifiable barrier to implementing the SSI&#xD;
           checklist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims and Design: Methicillin-resistant Staphylococcus aureus (MRSA), accounts for an&#xD;
      estimated 94,000 invasive infections and 19,000 deaths annually in the U.S. In order to&#xD;
      prevent MRSA infections among Veterans, the VA successfully implemented the VA MRSA&#xD;
      Prevention Initiative that has reduced patient-to-patient transmission of MRSA. However, this&#xD;
      Initiative does not prevent most MRSA surgical site infections (SSIs) because MRSA SSIs are&#xD;
      usually caused by MRSA transferring from a patient's nose to their own surgical incision&#xD;
      site. Cardiac surgery and total joint arthroplasty (TJA; e.g. hip or knee surgery) are among&#xD;
      the most common operations performed by the VA and are associated with particularly high&#xD;
      clinical and economic impact. In order to eliminate MRSA SSIs in the VA, the study group&#xD;
      developed a checklist based on a meta-analysis of studies that assessed methods to prevent&#xD;
      gram-positive SSIs among TJA and cardiac surgery patients. This SSI Checklist includes&#xD;
      preoperatively testing a surgical patient's nose for asymptomatic MRSA colonization. If the&#xD;
      patient is MRSA colonized, s/he will be treated with prophylactic nasal mupirocin ointment,&#xD;
      chlorhexidine gluconate baths, and antibiotic prophylaxis with both cefazolin and vancomycin.&#xD;
      The SSI Checklist will be implemented in 10 VA Medical Centers (VAMCs). A high-quality&#xD;
      quasi-experimental study, with a qualitative process evaluation will be performed to assess&#xD;
      the SSI Checklist. The goals of this project are 1) to assess the effectiveness and&#xD;
      cost-effectiveness of the checklist to prevent MRSA SSIs among Veterans undergoing TJA or&#xD;
      cardiac surgery, and 2) to assess barriers and facilitators to checklist implementation.&#xD;
&#xD;
      Methods: This study includes both quantitative and qualitative components. In the&#xD;
      quantitative component, the SSI Checklist will be implemented in 10 VAMCs for 3 years and&#xD;
      outcomes will be compared between the intervention group and two control groups: 1) 5 years&#xD;
      of historic data from the same 10 VAMCs, 2) 8 years (5 historic year and 3 intervention&#xD;
      years) of concurrent data from other VAMCs that did not implement the SSI Checklist. Study&#xD;
      endpoints will include: 1) MRSA SSIs as defined by the Centers for Disease Control and&#xD;
      Prevention (CDC); 2) SSIs caused by other pathogens; 3) cost per SSI prevented, cost per&#xD;
      life-saved, cost per MRSA SSI prevented and cost per quality-adjusted life-year (QALY) saved.&#xD;
      VA databases including VA National Surgical Quality Improvement Program (VASQIP), VA Decision&#xD;
      Support System, VA Inpatient Evaluation Center (IPEC) and Veterans' Informatics &amp; Computing&#xD;
      Infrastructure (VINCI) will be used to collect data. Time series analysis and linear mixed&#xD;
      effects models will be used for the statistical analysis. In the qualitative component, a&#xD;
      process evaluation will be conducted at 6 different VAMCs, which includes collecting data&#xD;
      before, during and after implementation, to examine the contextual factors and stakeholder&#xD;
      perspectives that influence adoption of the SSI Checklist. Observations and semi-structured&#xD;
      interviews will be conducted in Years 1 and 3, along with thematic content analysis, to&#xD;
      examine facilitators and barriers to the implementation at the different study sites. The&#xD;
      Consolidated Framework for Implementation Research will be used to guide the process&#xD;
      evaluation and provide the foundation for a systematic evaluation of local contextual factors&#xD;
      that influence implementation of the SSI Checklist. The products of this study include a&#xD;
      validated SSI Checklist, a business-case analysis, an implementation toolkit, and a team&#xD;
      experienced in checklist implementation for prevention of infections. At the end of this&#xD;
      study period, the study team will meet with operational partners including National&#xD;
      Infectious Disease Program Office (NIDS) and the MRSA / Multidrug-resistant Program Office&#xD;
      (MDRO), and the National Center for Occupational Health and Infection Control (COHIC) to&#xD;
      discuss implementing this checklist nationwide as part of the VA MRSA Prevention Initiative.&#xD;
      This study has high potential to significantly decrease SSI, and in turn morbidity and&#xD;
      mortality due to SSIs, in our Nation's Veterans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2014</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Superficial and deep/organ space MRSA infections</measure>
    <time_frame>90 days postoperatively</time_frame>
    <description>Superficial and deep/organ space MRSA infections, 90 days postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Superficial and deep/organ space MRSA infections</measure>
    <time_frame>one year postoperatively</time_frame>
    <description>The investigators chose 90-days rather than 1 year for the primary outcome measure since not all patients in the study will be able to be followed for 1 year due to the timing of the study. However, since the investigators will be able to follow 83% of the cohort for 1-year post-operatively, the investigators will perform this secondary analysis in which the investigators will include only patients who were followed for one year. However, it is unlikely that the 90-day analysis and 1 year analysis will differ significantly because over 75% of SSIs are detected within 30 days, in fact most SSI manifest within 22 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance with the entire pre-surgical bundle and individual bundle components</measure>
    <time_frame>30-days pre-surgery to day of surgery</time_frame>
    <description>This will be established electronically, through measurement of mupirocin prescription, CHG prescription and swab collection, as well as utilizing the compliance information collected on patient intake on the day of surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of postoperative stay</measure>
    <time_frame>Duration of postoperative stay, an expected average of 3 days</time_frame>
    <description>Duration of postoperative stay, an expected average of 3 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Up to 1-year post-surgery</time_frame>
    <description>All-cause mortality, Up to 1-year post-surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>90-days postsurgery</time_frame>
    <description>Readmission, 90-days postsurgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mupirocin and Chlorhexidine resistance in MRSA positive bacterial isolates</measure>
    <time_frame>30-days pre-surgery to 90-days post-surgery</time_frame>
    <description>The investigators will test bacterial isolates from MRSA positive patients at the 10 interventions sites. The VA is mandated to take nasal swabs from each patient preoperatively. For those patients who are MRSA positive, the investigators will have the bacterial isolates sent to the Iowa City site to be tested for resistance to mupirocin and CHG. The investigators will also collect bacterial isolates from patients who experience surgical site infections during the study. These isolates will also be tested for mupirocin and CHG resistance.&#xD;
The purpose of this testing is to a) ensure the investigators' study checklist does not cause mupirocin or CHG resistance by b) determining if resistance was present at the initial nasal swab, or if resistance occurred after performance of study checklist.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1794</enrollment>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Surgical Site Infection Checklist</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA):&#xD;
ecolonize with intranasal Mupirocin ointment BID x 5 days&#xD;
hlorhexidine gluconate (CHG) bathing (daily x 5 days, using wipes or liquid)&#xD;
efazolin plus Vancomycin (no Vanco for MSSA positive)&#xD;
Patient has a known negative Staph aureus pre-op screening result:&#xD;
HG bathing (night before &amp; morning of surgery using wipes or liquid)&#xD;
efazolin&#xD;
Patient was not screened or results are unknown at time of surgery:&#xD;
ecolonize with intranasal Mupirocin ointment (start BID x 5 days; discontinue if negative screen)&#xD;
HG bathing (start daily bath 5 days before operation if possible; at a minimum bathe the night before &amp; morning of surgery using wipes or liquid)&#xD;
efazolin plus Vancomycin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mupirocin</intervention_name>
    <description>Patients with known positive MRSA or MSSA and patients who have unknown status will decolonize BID x 5 days</description>
    <arm_group_label>Surgical Site Infection Checklist</arm_group_label>
    <other_name>Bactroban</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine gluconate</intervention_name>
    <description>Patients that are MRSA or MSSA positive or have unknown status will bathe in CHG daily x 5 days.&#xD;
Patients that are MRSA or MSSA negative will bathe with CHG the night before and morning of surgery.</description>
    <arm_group_label>Surgical Site Infection Checklist</arm_group_label>
    <other_name>Chlorhexidine Gluconate in IMS, CHG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefazolin</intervention_name>
    <description>All patients will receive Cefazolin during surgery</description>
    <arm_group_label>Surgical Site Infection Checklist</arm_group_label>
    <other_name>Ancef, Kefzol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin</intervention_name>
    <description>Patients who are positive for MRSA, or have unknown MRSA status, will receive vancomycin along with cefazolin during surgery.</description>
    <arm_group_label>Surgical Site Infection Checklist</arm_group_label>
    <other_name>vancocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nasal Povidone Iodine</intervention_name>
    <description>The purpose of this research is to evaluate a SSI checklist. This checklist includes decolonizing a patient's nose and skin and optimizing antibiotics prior to surgery. At the time that we wrote it, the predominate product to decolonize patient's noses was mupirocin. However, in 2017, an FDA final monograph stated that nasal povidone-iodine may be used for pre-surgical decolonization. Nasal povidone-iodine should be able to overcome barriers to checklist implementation that we identified in Aim 3. We now plan to replace the nasal agent mupirocin with the nasal agent povidone-iodine at 3 participating medical centers (Iowa City VA, Minneapolis VA and Portland VA) to assess whether this overcomes the barriers to our SSI checklist.</description>
    <arm_group_label>Surgical Site Infection Checklist</arm_group_label>
    <other_name>Povidone Iodine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Retrospective Control Group Inclusion Criteria:&#xD;
&#xD;
          -  Patients identified in VA databases (e.g. VASQIP) by ICD-9 procedure codes as&#xD;
             undergoing total joint arthroplasty or cardiac surgery at the 10 intervention VA&#xD;
             Medical Centers during the 5 year preintervention period (2008-2013)&#xD;
&#xD;
        Concurrent Non-equivalent Control Group Inclusion Criteria:&#xD;
&#xD;
          -  Patients identified in VA databases (e.g. VASQIP) by ICD-9 procedure codes as&#xD;
             undergoing total joint arthroplasty or cardiac surgery at VA Medical Centers not&#xD;
             included in the intervention group during the 8 years evaluated (5 years&#xD;
             pre-intervention to match with the retrospective control group and 3 years of the&#xD;
             intervention.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For All Patient Groups:&#xD;
&#xD;
          -  Have an ICD-9 diagnosis code consistent with endocarditis&#xD;
&#xD;
          -  Have any documented infection before the surgical procedure&#xD;
&#xD;
          -  Undergo cardiac transplants or cardiac procedures performed using the percutaneous or&#xD;
             thoracotomy approach&#xD;
&#xD;
          -  Undergoing hip and knee revisions&#xD;
&#xD;
          -  Documented allergies to mupirocin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eli N. Perencevich, MD MS BS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Iowa City VA Health Care System, Iowa City, IA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miami VA Healthcare System, Miami, FL</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa City VA Health Care System, Iowa City, IA</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52246-2208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Ann Arbor Healthcare System, Ann Arbor, MI</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis VA Health Care System, Minneapolis, MN</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68105-1873</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Portland Health Care System, Portland, OR</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Texas Health Care System, San Antonio, TX</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Salt Lake City Health Care System, Salt Lake City, UT</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William S. Middleton Memorial Veterans Hospital, Madison, WI</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Carrel M, Goto M, Schweizer ML, David MZ, Livorsi D, Perencevich EN. Diffusion of clindamycin-resistant and erythromycin-resistant methicillin-susceptible Staphylococcus aureus (MSSA), potential ST398, in United States Veterans Health Administration Hospitals, 2003-2014. Antimicrob Resist Infect Control. 2017 Jun 5;6:55. doi: 10.1186/s13756-017-0212-1. eCollection 2017.</citation>
    <PMID>28593043</PMID>
  </reference>
  <reference>
    <citation>Goto M, Schweizer ML, Vaughan-Sarrazin MS, Perencevich EN, Livorsi DJ, Diekema DJ, Richardson KK, Beck BF, Alexander B, Ohl ME. Association of Evidence-Based Care Processes With Mortality in Staphylococcus aureus Bacteremia at Veterans Health Administration Hospitals, 2003-2014. JAMA Intern Med. 2017 Oct 1;177(10):1489-1497. doi: 10.1001/jamainternmed.2017.3958. Erratum In: JAMA Intern Med. 2017 Oct 1;177(10):1544.</citation>
    <PMID>28873140</PMID>
  </reference>
  <reference>
    <citation>Safdar N, Perencevich E. Crossing the quality chasm for Clostridium difficile infection prevention. BMJ Qual Saf. 2015 Jul;24(7):409-11. doi: 10.1136/bmjqs-2015-004344. Epub 2015 May 15. No abstract available.</citation>
    <PMID>25979001</PMID>
  </reference>
  <results_reference>
    <citation>Singh N, Nair R, Goto M, Carvour ML, Carnahan R, Field EH, Lenert P, Vaughan-Sarrazin M, Schweizer ML, Perencevich EN. Risk of Recurrent Staphylococcus aureus Prosthetic Joint Infection in Rheumatoid Arthritis Patients-A Nationwide Cohort Study. Open Forum Infect Dis. 2019 Oct 19;6(11):ofz451. doi: 10.1093/ofid/ofz451. eCollection 2019 Nov.</citation>
    <PMID>31737738</PMID>
  </results_reference>
  <results_reference>
    <citation>Pfeiffer CD, Williams HB, Flegal H, Klutts JS, Evans M, Jones MM. 493. Laboratory Evaluation and Epidemiology of Carbapenemase-Producing Carbapenem-Resistant Enterobacteriaceae in Department of Veterans Affairs, 2017. [Abstract]. Open forum infectious diseases. 2019 Oct 23; 6(Supplement_2):S240-S241.</citation>
  </results_reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>March 10, 2021</last_update_submitted>
  <last_update_submitted_qc>March 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MRSA</keyword>
  <keyword>surgical site infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iodine</mesh_term>
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Vancomycin</mesh_term>
    <mesh_term>Cefazolin</mesh_term>
    <mesh_term>Mupirocin</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 2, 2022</submitted>
    <returned>September 12, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02216227
org study id: CRE 12-291
nct id: NCT02216227
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The goals of this project are 1) to assess the effectiveness and cost-effectiveness of the
      checklist to prevent MRSA SSIs among Veterans undergoing TJA or cardiac surgery, and 2) to
      assess barriers and facilitators to checklist implementation.

      Hypotheses:

        1. The SSI checklist will be effective at reducing MRSA SSIs among total joint arthroplasty
           and cardiac surgery patients.

        2. Implementation of the checklist will be associated with an overall reduction in SSIs
           caused by all pathogens.

        3. The SSI Checklist will be cost-saving since it will prevent many expensive SSIs.

        4. Preoperative MRSA testing will be a modifiable barrier to implementing the SSI
           checklist.
Aims and Design: Methicillin-resistant Staphylococcus aureus (MRSA), accounts for an
      estimated 94,000 invasive infections and 19,000 deaths annually in the U.S. In order to
      prevent MRSA infections among Veterans, the VA successfully implemented the VA MRSA
      Prevention Initiative that has reduced patient-to-patient transmission of MRSA. However, this
      Initiative does not prevent most MRSA surgical site infections (SSIs) because MRSA SSIs are
      usually caused by MRSA transferring from a patient's nose to their own surgical incision
      site. Cardiac surgery and total joint arthroplasty (TJA; e.g. hip or knee surgery) are among
      the most common operations performed by the VA and are associated with particularly high
      clinical and economic impact. In order to eliminate MRSA SSIs in the VA, the study group
      developed a checklist based on a meta-analysis of studies that assessed methods to prevent
      gram-positive SSIs among TJA and cardiac surgery patients. This SSI Checklist includes
      preoperatively testing a surgical patient's nose for asymptomatic MRSA colonization. If the
      patient is MRSA colonized, s/he will be treated with prophylactic nasal mupirocin ointment,
      chlorhexidine gluconate baths, and antibiotic prophylaxis with both cefazolin and vancomycin.
      The SSI Checklist will be implemented in 10 VA Medical Centers (VAMCs). A high-quality
      quasi-experimental study, with a qualitative process evaluation will be performed to assess
      the SSI Checklist. The goals of this project are 1) to assess the effectiveness and
      cost-effectiveness of the checklist to prevent MRSA SSIs among Veterans undergoing TJA or
      cardiac surgery, and 2) to assess barriers and facilitators to checklist implementation.

      Methods: This study includes both quantitative and qualitative components. In the
      quantitative component, the SSI Checklist will be implemented in 10 VAMCs for 3 years and
      outcomes will be compared between the intervention group and two control groups: 1) 5 years
      of historic data from the same 10 VAMCs, 2) 8 years (5 historic year and 3 intervention
      years) of concurrent data from other VAMCs that did not implement the SSI Checklist. Study
      endpoints will include: 1) MRSA SSIs as defined by the Centers for Disease Control and
      Prevention (CDC); 2) SSIs caused by other pathogens; 3) cost per SSI prevented, cost per
      life-saved, cost per MRSA SSI prevented and cost per quality-adjusted life-year (QALY) saved.
      VA databases including VA National Surgical Quality Improvement Program (VASQIP), VA Decision
      Support System, VA Inpatient Evaluation Center (IPEC) and Veterans' Informatics & Computing
      Infrastructure (VINCI) will be used to collect data. Time series analysis and linear mixed
      effects models will be used for the statistical analysis. In the qualitative component, a
      process evaluation will be conducted at 6 different VAMCs, which includes collecting data
      before, during and after implementation, to examine the contextual factors and stakeholder
      perspectives that influence adoption of the SSI Checklist. Observations and semi-structured
      interviews will be conducted in Years 1 and 3, along with thematic content analysis, to
      examine facilitators and barriers to the implementation at the different study sites. The
      Consolidated Framework for Implementation Research will be used to guide the process
      evaluation and provide the foundation for a systematic evaluation of local contextual factors
      that influence implementation of the SSI Checklist. The products of this study include a
      validated SSI Checklist, a business-case analysis, an implementation toolkit, and a team
      experienced in checklist implementation for prevention of infections. At the end of this
      study period, the study team will meet with operational partners including National
      Infectious Disease Program Office (NIDS) and the MRSA / Multidrug-resistant Program Office
      (MDRO), and the National Center for Occupational Health and Infection Control (COHIC) to
      discuss implementing this checklist nationwide as part of the VA MRSA Prevention Initiative.
      This study has high potential to significantly decrease SSI, and in turn morbidity and
      mortality due to SSIs, in our Nation's Veterans.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Superficial and deep/organ space MRSA infections
time frame: 90 days postoperatively
description: Superficial and deep/organ space MRSA infections, 90 days postoperatively.
measure: Superficial and deep/organ space MRSA infections
time frame: one year postoperatively
description: The investigators chose 90-days rather than 1 year for the primary outcome measure since not all patients in the study will be able to be followed for 1 year due to the timing of the study. However, since the investigators will be able to follow 83% of the cohort for 1-year post-operatively, the investigators will perform this secondary analysis in which the investigators will include only patients who were followed for one year. However, it is unlikely that the 90-day analysis and 1 year analysis will differ significantly because over 75% of SSIs are detected within 30 days, in fact most SSI manifest within 22 days.
measure: Compliance with the entire pre-surgical bundle and individual bundle components
time frame: 30-days pre-surgery to day of surgery
description: This will be established electronically, through measurement of mupirocin prescription, CHG prescription and swab collection, as well as utilizing the compliance information collected on patient intake on the day of surgery.
measure: Length of postoperative stay
time frame: Duration of postoperative stay, an expected average of 3 days
description: Duration of postoperative stay, an expected average of 3 days.
measure: All-cause mortality
time frame: Up to 1-year post-surgery
description: All-cause mortality, Up to 1-year post-surgery.
measure: Readmission
time frame: 90-days postsurgery
description: Readmission, 90-days postsurgery.
measure: Mupirocin and Chlorhexidine resistance in MRSA positive bacterial isolates
time frame: 30-days pre-surgery to 90-days post-surgery
description: The investigators will test bacterial isolates from MRSA positive patients at the 10 interventions sites. The VA is mandated to take nasal swabs from each patient preoperatively. For those patients who are MRSA positive, the investigators will have the bacterial isolates sent to the Iowa City site to be tested for resistance to mupirocin and CHG. The investigators will also collect bacterial isolates from patients who experience surgical site infections during the study. These isolates will also be tested for mupirocin and CHG resistance.
The purpose of this testing is to a) ensure the investigators' study checklist does not cause mupirocin or CHG resistance by b) determining if resistance was present at the initial nasal swab, or if resistance occurred after performance of study checklist.
arm group label: Surgical Site Infection Checklist
arm group type: Experimental
description: Patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA):
ecolonize with intranasal Mupirocin ointment BID x 5 days
hlorhexidine gluconate (CHG) bathing (daily x 5 days, using wipes or liquid)
efazolin plus Vancomycin (no Vanco for MSSA positive)
Patient has a known negative Staph aureus pre-op screening result:
HG bathing (night before & morning of surgery using wipes or liquid)
efazolin
Patient was not screened or results are unknown at time of surgery:
ecolonize with intranasal Mupirocin ointment (start BID x 5 days; discontinue if negative screen)
HG bathing (start daily bath 5 days before operation if possible; at a minimum bathe the night before & morning of surgery using wipes or liquid)
efazolin plus Vancomycin
intervention type: Drug
intervention name: Mupirocin
description: Patients with known positive MRSA or MSSA and patients who have unknown status will decolonize BID x 5 days
arm group label: Surgical Site Infection Checklist
other name: Bactroban
intervention type: Drug
intervention name: Chlorhexidine gluconate
description: Patients that are MRSA or MSSA positive or have unknown status will bathe in CHG daily x 5 days.
Patients that are MRSA or MSSA negative will bathe with CHG the night before and morning of surgery.
arm group label: Surgical Site Infection Checklist
other name: Chlorhexidine Gluconate in IMS, CHG
intervention type: Drug
intervention name: Cefazolin
description: All patients will receive Cefazolin during surgery
arm group label: Surgical Site Infection Checklist
other name: Ancef, Kefzol
intervention type: Drug
intervention name: Vancomycin
description: Patients who are positive for MRSA, or have unknown MRSA status, will receive vancomycin along with cefazolin during surgery.
arm group label: Surgical Site Infection Checklist
other name: vancocin
intervention type: Drug
intervention name: Nasal Povidone Iodine
description: The purpose of this research is to evaluate a SSI checklist. This checklist includes decolonizing a patient's nose and skin and optimizing antibiotics prior to surgery. At the time that we wrote it, the predominate product to decolonize patient's noses was mupirocin. However, in 2017, an FDA final monograph stated that nasal povidone-iodine may be used for pre-surgical decolonization. Nasal povidone-iodine should be able to overcome barriers to checklist implementation that we identified in Aim 3. We now plan to replace the nasal agent mupirocin with the nasal agent povidone-iodine at 3 participating medical centers (Iowa City VA, Minneapolis VA and Portland VA) to assess whether this overcomes the barriers to our SSI checklist.
arm group label: Surgical Site Infection Checklist
other name: Povidone Iodine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eli N. Perencevich, MD MS BS
role: Principal Investigator
affiliation: Iowa City VA Health Care System, Iowa City, IA
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country: United States
citation: Carrel M, Goto M, Schweizer ML, David MZ, Livorsi D, Perencevich EN. Diffusion of clindamycin-resistant and erythromycin-resistant methicillin-susceptible Staphylococcus aureus (MSSA), potential ST398, in United States Veterans Health Administration Hospitals, 2003-2014. Antimicrob Resist Infect Control. 2017 Jun 5;6:55. doi: 10.1186/s13756-017-0212-1. eCollection 2017.
PMID: 28593043
citation: Goto M, Schweizer ML, Vaughan-Sarrazin MS, Perencevich EN, Livorsi DJ, Diekema DJ, Richardson KK, Beck BF, Alexander B, Ohl ME. Association of Evidence-Based Care Processes With Mortality in Staphylococcus aureus Bacteremia at Veterans Health Administration Hospitals, 2003-2014. JAMA Intern Med. 2017 Oct 1;177(10):1489-1497. doi: 10.1001/jamainternmed.2017.3958. Erratum In: JAMA Intern Med. 2017 Oct 1;177(10):1544.
PMID: 28873140
citation: Safdar N, Perencevich E. Crossing the quality chasm for Clostridium difficile infection prevention. BMJ Qual Saf. 2015 Jul;24(7):409-11. doi: 10.1136/bmjqs-2015-004344. Epub 2015 May 15. No abstract available.
PMID: 25979001
citation: Singh N, Nair R, Goto M, Carvour ML, Carnahan R, Field EH, Lenert P, Vaughan-Sarrazin M, Schweizer ML, Perencevich EN. Risk of Recurrent Staphylococcus aureus Prosthetic Joint Infection in Rheumatoid Arthritis Patients-A Nationwide Cohort Study. Open Forum Infect Dis. 2019 Oct 19;6(11):ofz451. doi: 10.1093/ofid/ofz451. eCollection 2019 Nov.
PMID: 31737738
citation: Pfeiffer CD, Williams HB, Flegal H, Klutts JS, Evans M, Jones MM. 493. Laboratory Evaluation and Epidemiology of Carbapenemase-Producing Carbapenem-Resistant Enterobacteriaceae in Department of Veterans Affairs, 2017. [Abstract]. Open forum infectious diseases. 2019 Oct 23; 6(Supplement_2):S240-S241.
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection
mesh term: Iodine
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
mesh term: Povidone-Iodine
mesh term: Vancomycin
mesh term: Cefazolin
mesh term: Mupirocin
mesh term: Povidone
sharing ipd: No
submitted: November 2, 2022
returned: September 12, 2023