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Checklist to Prevent MRSA Surgical Site Infections

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ClinicalTrials.gov Identifier: NCT02216227
Recruitment Status : Recruiting
First Posted : August 13, 2014
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Mupirocin Drug: Chlorhexidine gluconate Drug: Cefazolin Drug: Vancomycin Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10748 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Checklist to Prevent MRSA Surgical Site Infections
Actual Study Start Date : April 1, 2014
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Arm Intervention/treatment
Experimental: Surgical Site Infection Checklist

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
Drug: Mupirocin
Patients with known positive MRSA or MSSA and patients who have unknown status will decolonize BID x 5 days
Other Name: Bactroban

Drug: Chlorhexidine gluconate

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.

Other Name: Chlorhexidine Gluconate in IMS, CHG

Drug: Cefazolin
All patients will receive Cefazolin during surgery
Other Name: Ancef, Kefzol

Drug: Vancomycin
Patients who are positive for MRSA, or have unknown MRSA status, will receive vancomycin along with cefazolin during surgery.
Other Name: vancocin




Primary Outcome Measures :
  1. Superficial and deep/organ space MRSA infections [ Time Frame: 90 days postoperatively ]

Secondary Outcome Measures :
  1. Superficial and deep/organ space MRSA infections [ Time Frame: one year postoperatively ]
    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.

  2. Compliance with the entire pre-surgical bundle and individual bundle components [ Time Frame: 30-days pre-surgery to day of surgery ]
    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.

  3. Length of postoperative stay [ Time Frame: Duration of postoperative stay, an expected average of 3 days ]
  4. All-cause mortality [ Time Frame: Up to 1-year post-surgery ]
  5. Readmission [ Time Frame: 90-days postsurgery ]
  6. Mupirocin and Chlorhexidine resistance in MRSA positive bacterial isolates [ Time Frame: 30-days pre-surgery to 90-days post-surgery ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Retrospective Control Group Inclusion Criteria:

  • Patients identified in VA databases (e.g. VASQIP) by ICD-9 procedure codes as undergoing total joint arthroplasty or cardiac surgery at the 10 intervention VA Medical Centers during the 5 year preintervention period (2008-2013)

Concurrent Non-equivalent Control Group Inclusion Criteria:

  • Patients identified in VA databases (e.g. VASQIP) by ICD-9 procedure codes as undergoing total joint arthroplasty or cardiac surgery at VA Medical Centers not included in the intervention group during the 8 years evaluated (5 years pre-intervention to match with the retrospective control group and 3 years of the intervention.)

Exclusion Criteria:

For All Patient Groups:

  • Have an ICD-9 diagnosis code consistent with endocarditis
  • Have any documented infection before the surgical procedure
  • Undergo cardiac transplants or cardiac procedures performed using the percutaneous or thoracotomy approach
  • Undergoing hip and knee revisions
  • Documented allergies to mupirocin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216227


Contacts
Contact: Eli N Perencevich, MD MS BS (319) 338-0581 ext 3535 eli.perencevich@va.gov

Locations
United States, Florida
Miami VA Healthcare System, Miami, FL Recruiting
Miami, Florida, United States, 33125
Contact: Gio J Baracco Lira, MD    305-575-7000 ext 4430    Gio.Baracco@va.gov   
Sub-Investigator: Gio J Baracco, MD         
United States, Iowa
Iowa City VA Health Care System, Iowa City, IA Recruiting
Iowa City, Iowa, United States, 52246-2208
Contact: Eli N Perencevich, MD MS BS    319-338-0581 ext 3535    eli.perencevich@va.gov   
Principal Investigator: Eli N. Perencevich, MD MS BS         
Sub-Investigator: Heather S Reisinger, PhD         
Sub-Investigator: Marin L. Schweizer-Looby, PhD BS         
Sub-Investigator: Mary S. Vaughan-Sarrazin, PhD MA         
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Daniel J Morgan, MD MS    (410) 706-1734    Daniel.Morgan2@va.gov   
Sub-Investigator: Daniel Josiah Morgan, MD MS         
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Kalpana Gupta, MD MPH    857-203-5086    kalpana.gupta@va.gov   
Sub-Investigator: Kalpana Gupta, MD MPH         
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Suzanne F Bradley, MD    734-845-3072    Suzanne.Bradley2@va.gov   
Sub-Investigator: Sarah L. Krein, PhD RN         
Sub-Investigator: Suzanne F Bradley, MD         
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Joseph R Thurn, MD MPH    612-467-4185    seph.thurn@va.gov   
Sub-Investigator: Joseph R Thurn, MD MPH         
United States, Nebraska
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE Recruiting
Omaha, Nebraska, United States, 68105-1873
Contact: Marvin J Bittner, MD    402-995-5219    Marvin.Bittner@va.gov   
Sub-Investigator: Marvin J Bittner, MD         
United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: Graeme N Forrest, MBBS MD    503-220-8262 ext 52118    Graeme.forrest@va.gov   
Sub-Investigator: Christopher D. Pfeiffer, MD MHS         
Sub-Investigator: Graeme N. Forrest, MBBS MD         
United States, Texas
South Texas Health Care System, San Antonio, TX Recruiting
San Antonio, Texas, United States, 78229
Contact: Jose A Cadena Zuluaga, MD    210-617-5300    Jose.Cadena-Zuluaga@va.gov   
Sub-Investigator: Luci Leykum, MD MBA MSc         
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City, UT Recruiting
Salt Lake City, Utah, United States, 84148
Contact: Michael A Rubin, MD PhD    (801) 582-1565 ext 1960    michael.rubin2@va.gov   
Sub-Investigator: Michael Adam Rubin, MD PhD         
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI Recruiting
Madison, Wisconsin, United States, 53705
Contact: Christopher J Crnich, MD PhD MS    (608) 256-1901    christopher.crnich@va.gov   
Sub-Investigator: Christopher John Crnich, MD PhD MS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Eli N. Perencevich, MD MS BS Iowa City VA Health Care System, Iowa City, IA

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02216227     History of Changes
Other Study ID Numbers: CRE 12-291
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
MRSA
surgical site infection

Additional relevant MeSH terms:
Surgical Wound Infection
Infection
Communicable Diseases
Wound Infection
Postoperative Complications
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Vancomycin
Cefazolin
Mupirocin
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action