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Clinical Trials/NCT04449705
NCT04449705WithdrawnNot Applicable

Quality Assessment of a Multifaceted, Perioperative Infection Control Bundle

Randy Loftus1 site in 1 countryStarted: July 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
1
Primary Endpoint
Perioperative transmission of S. aureus

Study Overview

Brief Summary

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.

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Perioperative transmission of S. aureus

Time Frame: 24 hours

S. aureus transmission event

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Randy Loftus
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Randy Loftus

Principle Investigator

University of Iowa

Study Sites (1)

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