Quality Assessment of a Multifaceted, Perioperative Infection Control Bundle

Sponsor
Randy Loftus (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04449705
Collaborator
(none)
0
1
3
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 [Patient Registry]
    Actual Enrollment :
    0 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Quality Assessment of a Multifaceted, Perioperative Infection Control Bundle
    Anticipated Study Start Date :
    Jul 1, 2020
    Anticipated Primary Completion Date :
    Sep 30, 2020
    Anticipated Study Completion Date :
    Sep 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Perioperative transmission of S. aureus [24 hours]

      S. aureus transmission event

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Randy Loftus

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Randy Loftus, Principle Investigator, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT04449705
    Other Study ID Numbers:
    • 202006248
    First Posted:
    Jun 29, 2020
    Last Update Posted:
    Jun 15, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 15, 2021