Checklist to Prevent MRSA Surgical Site Infections

NCT02216227 | Completed Results

• 1 other identifier: CRE 12-291
• Study Type: interventional
• Target: 23,005
• Locations: 1 country
• Sites: 11

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

Conditions

Surgical Site Infection

Keywords

MRSA; surgical site infection

Outcome Measures

Primary Outcomes (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.

  90 days postoperatively

Secondary Outcomes (6)

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

  one year postoperatively

• Participants Compliant With the Entire Pre-surgical Bundle and Individual Bundle Components

  30-days pre-surgery to day of surgery

• Length of Postoperative Stay

  Duration of postoperative stay, an expected average of 3 days

• All-cause Mortality

  Up to 1-year post-surgery

• Readmission

  90-days postsurgery

Study Arms (1)

Surgical Site Infection Checklist

EXPERIMENTAL

Patient 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

Drug: Mupirocin; Drug: Chlorhexidine gluconate; Drug: Cefazolin; Drug: Vancomycin; Drug: Nasal Povidone Iodine

Interventions

Mupirocin DRUG

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

Also known as: Bactroban

Surgical Site Infection Checklist

Chlorhexidine gluconate DRUG

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.

Also known as: Chlorhexidine Gluconate in IMS, CHG

Surgical Site Infection Checklist

Cefazolin DRUG

All patients will receive Cefazolin during surgery

Also known as: Ancef, Kefzol

Surgical Site Infection Checklist

Vancomycin DRUG

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

Also known as: vancocin

Surgical Site Infection Checklist

Nasal Povidone Iodine DRUG

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.

Also known as: Povidone Iodine

Surgical Site Infection Checklist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (11)

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

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

Baltimore, Maryland, 21201, United States

Location

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

Boston, Massachusetts, 02130, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

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

Omaha, Nebraska, 68105-1873, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229, United States

Location

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

Salt Lake City, Utah, 84148, United States

Location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

Location

Related Publications (8)

• 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 BACKGROUND

• 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.

  PMID: 28873140 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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.

  RESULT

• 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.

  PMID: 33618788 RESULT

• 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.

  PMID: 37471087 RESULT

• 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.

  PMID: 36925849 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Mupirocin; chlorhexidine gluconate; Chromogranins; Cefazolin; Vancomycin; Povidone-Iodine

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

Secondary Outcomes measures data was not available due to funding constraints.

Results Point of Contact

• Title: Eli N Perencevich, MD MS BS
• Organization: Iowa City VA Health Care System, Iowa City, IA

eli.perencevich@va.gov

319-338-0581

Study Officials

• Eli N. Perencevich, MD MS BS

  Iowa City VA Health Care System, Iowa City, IA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: August 13, 2014
• Study Start: April 1, 2014
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 31, 2026
• Results First Posted: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)