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Checklist to Prevent MRSA Surgical Site Infections

Primary Purpose

Surgical Site Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mupirocin
Chlorhexidine gluconate
Cefazolin
Vancomycin
Nasal Povidone Iodine
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection focused on measuring MRSA, surgical site infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Miami VA Healthcare System, Miami, FL
  • Iowa City VA Health Care System, Iowa City, IA
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • Minneapolis VA Health Care System, Minneapolis, MN
  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
  • VA Portland Health Care System, Portland, OR
  • South Texas Health Care System, San Antonio, TX
  • VA Salt Lake City Health Care System, Salt Lake City, UT
  • William S. Middleton Memorial Veterans Hospital, Madison, WI

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgical Site Infection Checklist

Arm 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

Outcomes

Primary Outcome Measures

Superficial and deep/organ space MRSA infections
Superficial and deep/organ space MRSA infections, 90 days postoperatively.

Secondary Outcome Measures

Superficial and deep/organ space MRSA infections
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.
Compliance with the entire pre-surgical bundle and individual bundle components
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.
Length of postoperative stay
Duration of postoperative stay, an expected average of 3 days.
All-cause mortality
All-cause mortality, Up to 1-year post-surgery.
Readmission
Readmission, 90-days postsurgery.
Mupirocin and Chlorhexidine resistance in MRSA positive bacterial isolates
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.

Full Information

First Posted
July 22, 2014
Last Updated
March 10, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02216227
Brief Title
Checklist to Prevent MRSA Surgical Site Infections
Official Title
Checklist to Prevent MRSA Surgical Site Infections
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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: The SSI checklist will be effective at reducing MRSA SSIs among total joint arthroplasty and cardiac surgery patients. Implementation of the checklist will be associated with an overall reduction in SSIs caused by all pathogens. The SSI Checklist will be cost-saving since it will prevent many expensive SSIs. Preoperative MRSA testing will be a modifiable barrier to implementing the SSI checklist.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
MRSA, surgical site infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1794 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical Site Infection Checklist
Arm Type
Experimental
Arm 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(s)
Mupirocin
Other Intervention Name(s)
Bactroban
Intervention Description
Patients with known positive MRSA or MSSA and patients who have unknown status will decolonize BID x 5 days
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate
Other Intervention Name(s)
Chlorhexidine Gluconate in IMS, CHG
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Other Intervention Name(s)
Ancef, Kefzol
Intervention Description
All patients will receive Cefazolin during surgery
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Other Intervention Name(s)
vancocin
Intervention Description
Patients who are positive for MRSA, or have unknown MRSA status, will receive vancomycin along with cefazolin during surgery.
Intervention Type
Drug
Intervention Name(s)
Nasal Povidone Iodine
Other Intervention Name(s)
Povidone Iodine
Intervention 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.
Primary Outcome Measure Information:
Title
Superficial and deep/organ space MRSA infections
Description
Superficial and deep/organ space MRSA infections, 90 days postoperatively.
Time Frame
90 days postoperatively
Secondary Outcome Measure Information:
Title
Superficial and deep/organ space MRSA infections
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.
Time Frame
one year postoperatively
Title
Compliance with the entire pre-surgical bundle and individual bundle components
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.
Time Frame
30-days pre-surgery to day of surgery
Title
Length of postoperative stay
Description
Duration of postoperative stay, an expected average of 3 days.
Time Frame
Duration of postoperative stay, an expected average of 3 days
Title
All-cause mortality
Description
All-cause mortality, Up to 1-year post-surgery.
Time Frame
Up to 1-year post-surgery
Title
Readmission
Description
Readmission, 90-days postsurgery.
Time Frame
90-days postsurgery
Title
Mupirocin and Chlorhexidine resistance in MRSA positive bacterial isolates
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.
Time Frame
30-days pre-surgery to 90-days post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli N. Perencevich, MD MS BS
Organizational Affiliation
Iowa City VA Health Care System, Iowa City, IA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami VA Healthcare System, Miami, FL
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Iowa City VA Health Care System, Iowa City, IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246-2208
Country
United States
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105-1873
Country
United States
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
South Texas Health Care System, San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
William S. Middleton Memorial Veterans Hospital, Madison, WI
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28593043
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.
Results Reference
background
PubMed Identifier
28873140
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.
Results Reference
background
PubMed Identifier
25979001
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.
Results Reference
background
PubMed Identifier
31737738
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.
Results Reference
result
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.
Results Reference
result

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Checklist to Prevent MRSA Surgical Site Infections

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