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Surgical Site InfectionNCT02216227

Checklist to Prevent MRSA Surgical Site Infections

A study testing Mupirocin, Chlorhexidine gluconate and Cefazolin in people with Surgical Site Infection, run by VA Office of Research and Development at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Surgical Site Infection
What is being tested?
Mupirocin, Chlorhexidine gluconate and Cefazolin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23,005 participants
Where
11 sitesUnited States
Study dates
1 Apr 2014to 28 Feb 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    Baltimore, Maryland, 21201

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130

  • Iowa City VA Health Care System, Iowa City, IA

    Iowa City, Iowa, 52246-2208

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    Madison, Wisconsin, 53705

  • Miami VA Healthcare System, Miami, FL

    Miami, Florida, 33125

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417

  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

    Omaha, Nebraska, 68105-1873

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97239

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utah, 84148

  • South Texas Health Care System, San Antonio, TX

    San Antonio, Texas, 78229

Other trials in United States

About this study

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.
Read the 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.

Being tested
Mupirocin, Chlorhexidine gluconate, Cefazolin, Vancomycin, Nasal Povidone Iodine
Keywords
MRSA, surgical site infection
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MupirocinDrug

    Also called Bactroban

    Patients with known positive MRSA or MSSA and patients who have unknown status will decolonize BID x 5 days

  • Chlorhexidine gluconateDrug

    Also called Chlorhexidine Gluconate in IMS, CHG

    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.

  • CefazolinDrug

    Also called Ancef, Kefzol

    All patients will receive Cefazolin during surgery

  • VancomycinDrug

    Also called vancocin

    Patients who are positive for MRSA, or have unknown MRSA status, will receive vancomycin along with cefazolin during surgery.

  • Nasal Povidone IodineDrug

    Also called Povidone Iodine

    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.

Study groups in NCT02216227
Study groupRoleWhat they receive
Surgical Site Infection ChecklistExperimentalPatient has a known positive Staph aureus pre-op screening result (MRSA or MSSA): * decolonize with intranasal Mupirocin ointment BID x 5 days * chlorhexidine gluconate (CHG) bathing (daily x 5 days, using wipes or liquid) * cefazolin plus Vancomycin (no Vanco for MSSA positive) Patient has a known negative Staph aureus pre-op screening result: * CHG bathing (night before \& morning of surgery using wipes or liquid) * cefazolin Patient was not screened or results are unknown at time of surgery: * decolonize with intranasal Mupirocin ointment (start BID x 5 days; discontinue if negative screen) * CHG bathing (start daily bath 5 days before operation if possible; at a minimum bathe the night before \& morning of surgery using wipes or liquid) * cefazolin plus Vancomycin
Receives: Drug: Mupirocin; Drug: Chlorhexidine gluconate; Drug: Cefazolin; Drug: Vancomycin; Drug: Nasal Povidone Iodine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants With Superficial and Deep/Organ Space MRSA Infections Within 90 Days

    Participants with superficial and deep/organ space MRSA infections, 90 days postoperatively, as measured by VA electronic health data.

    Measured: 90 days postoperatively

Secondary outcomes (6)

  1. Participants With Superficial and Deep/Organ Space MRSA Infections Within 1 Year

    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.

    Measured: one year postoperatively

  2. Participants Compliant 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.

    Measured: 30-days pre-surgery to day of surgery

  3. Length of Postoperative Stay

    Duration of postoperative stay, an expected average of 3 days.

    Measured: Duration of postoperative stay, an expected average of 3 days

  4. All-cause Mortality

    All-cause mortality, Up to 1-year post-surgery.

    Measured: Up to 1-year post-surgery

  5. Readmission

    Readmission, 90-days postsurgery.

    Measured: 90-days postsurgery

  6. Participants With Mupirocin and Chlorhexidine Resistant MRSA Positive Bacterial Isolates

    The investigators will test bacterial isolates from MRSA positive patients at the 11 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.

    Measured: 30-days pre-surgery to 90-days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2014 (estimated)
  2. Study start1 Apr 2014
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23,005 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02216227
Sponsor's protocol ID
CRE 12-291
Status last verified
Mar 2026
First submitted
22 Jul 2014
Last updated
31 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28593043

  • 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.

    PubMed 28873140

  • 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.

    PubMed 25979001

  • 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.

    PubMed 31737738

  • 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.

  • Suzuki H, Clore GS, Perencevich EN, Hockett-Sherlock SM, Goto M, Nair R, Branch-Elliman W, Richardson KK, Gupta K, Beck BF, Alexander B, Balkenende EC, Schweizer ML. Development of a fully automated surgical site infection detection algorithm for use in cardiac and orthopedic surgery research. Infect Control Hosp Epidemiol. 2021 Oct;42(10):1215-1220. doi: 10.1017/ice.2020.1387. Epub 2021 Feb 23.

    PubMed 33618788

  • Suzuki H, Perencevich EN, Hockett Sherlock S, Clore GS, O'Shea AMJ, Forrest GN, Pfeiffer CD, Safdar N, Crnich C, Gupta K, Strymish J, Lira GB, Bradley S, Cadena-Zuluaga J, Rubin M, Bittner M, Morgan D, DeVries A, Miell K, Alexander B, Schweizer ML. Implementation of a Prevention Bundle to Decrease Rates of Staphylococcus aureus Surgical Site Infection at 11 Veterans Affairs Hospitals. JAMA Netw Open. 2023 Jul 3;6(7):e2324516. doi: 10.1001/jamanetworkopen.2023.24516.

    PubMed 37471087

  • Hockett Sherlock S, Goedken CC, Balkenende EC, Dukes KC, Perencevich EN, Reisinger HS, Forrest GN, Pfeiffer CD, West KA, Schweizer M. Strategies for the implementation of a nasal decolonization intervention to prevent surgical site infections within the Veterans Health Administration. Front Health Serv. 2022 Aug 17;2:920830. doi: 10.3389/frhs.2022.920830. eCollection 2022.

    PubMed 36925849

Questions about this trial

What is this clinical trial studying?

A study testing Mupirocin, Chlorhexidine gluconate and Cefazolin in people with Surgical Site Infection, run by VA Office of Research and Development at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Superficial and Deep/Organ Space MRSA Infections Within 90 Days (time frame: 90 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02216227, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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