Checklist to Prevent MRSA Surgical Site Infections
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02216227|
Recruitment Status : Recruiting
First Posted : August 13, 2014
Last Update Posted : July 17, 2018
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection||Drug: Mupirocin Drug: Chlorhexidine gluconate Drug: Cefazolin Drug: Vancomycin||Not Applicable|
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)|
|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|
Experimental: Surgical Site Infection Checklist
Patient has a known positive Staph aureus pre-op screening result (MRSA or MSSA):
Patient has a known negative Staph aureus pre-op screening result:
Patient was not screened or results are unknown at time of surgery:
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
All patients will receive Cefazolin during surgery
Other Name: Ancef, Kefzol
Patients who are positive for MRSA, or have unknown MRSA status, will receive vancomycin along with cefazolin during surgery.
Other Name: vancocin
- Superficial and deep/organ space MRSA infections [ Time Frame: 90 days postoperatively ]
- 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.
- 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.
- Length of postoperative stay [ Time Frame: Duration of postoperative stay, an expected average of 3 days ]
- All-cause mortality [ Time Frame: Up to 1-year post-surgery ]
- Readmission [ Time Frame: 90-days postsurgery ]
- 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.
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
|Contact: Eli N Perencevich, MD MS BS||(319) 338-0581 ext email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|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.email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Sub-Investigator: Christopher John Crnich, MD PhD MS|
|Principal Investigator:||Eli N. Perencevich, MD MS BS||Iowa City VA Health Care System, Iowa City, IA|