Quality Assessment of a Multifaceted, Perioperative Infection Control Bundle

Surgical site infections increase patient morbidity and healthcare costs. The Centers for Disease Control and Prevention emphasizes improved basic preventive measures to reduce bacterial transmission and infections for patients undergoing surgery. We conducted a previous study that showed our treatment bundle is highly effective.

Our current study planned to examine patterns/rate of S. aureus transmission to improve feedback widespread implementation of the perioperative infection prevention program at Iowa.

The purpose of this study is to assess the fidelity of the set of interventions in controlling perioperative S. aureus and to provide data feedback via surveillance involving epidemiology of transmission for system optimization.

Study Overview

• Status: Withdrawn
• Conditions: Perioperative Transmission

Detailed Description

The operating room schedule will be reviewed each day by the research assistant.

At the start of each case, the technician will obtain an OR PathTrac kit and will fill out required card indicating the OR number, the surgery date, and the type of surgery. The cards will be placed back into the kit. Sample collection will be directed via use of the kit. The first sample is the adjustable pressure-limiting valve and agent dial of the machine before patient entry (measures terminal cleaning), then provider (attending and assistant) hands after they enter but before patient interaction, then the provider nose and mouth after induction of anesthesia and patient stabilization, then provider hands, then same environmental sites, then provider sites again, then stopcock.

A transmission event will be defined as detection of S. aureus pathogens among 2 distinct, epidemiologically-related reservoirs within a surveillance unit. The software platform will process transmission dynamics in order to continually summarize the epidemiology of S. aureus transmission, with results updated daily as case-pair data is continually entered into the program. This information will be continually displayed to identify the most common reservoir of origin, the most common transmission locations (vectors), and involvement of key portals of entry (stopcocks). These will become improvement targets with feedback provided via automated failure mode analysis reports. The research assistant will use the reports to continually optimize the interventions during the observational period.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery at the University of Iowa

Description

Inclusion Criteria:

• Adult (at least 18 years old) patient undergoing surgery requiring anesthesia and placement of a peripheral and/or central intravenous catheter.

Exclusion Criteria:

• <18 years old, Shellfish, iodine, chlorhexidine allergies, no anesthesia and/or placement of peripheral and/or central intravenous catheter required

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative transmission of S. aureus	S. aureus transmission event	24 hours

Collaborators and Investigators

• Sponsor: Randy Loftus
• Investigators: Principal Investigator: Randyt W Loftus, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 202006248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Request for information must be submitted as a proposal for PI review. Not before 2 years. Use subject to PI review
• IPD Sharing Time Frame: 2 years from study completion
• IPD Sharing Access Criteria: A written proposal submitted to PI for review
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No