Reducing Perioperative S. Aureus Transmission

June 7, 2022 updated by: Randy Loftus

Reducing Perioperative S. Aureus Transmission Via Use of an Evidence-Based, Multimodal Program Driven by an Innovative Software Platform (OR Path Trac)

The purpose of this study is to prevent the spread of S. aureus, a dangerous bacterium, within the operating room and between patients undergoing surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to prevent the spread of S. aureus, a dangerous bacterium, within the operating room and between patients undergoing surgery. The investigators will combine several approaches in a "bundle" of activities to achieve this goal. The bundle will include removal of bacterial pathogens from patient skin sites before surgery, from provider hands before, during, and after surgery, from environmental surfaces before and after terminal cleaning, and from the injection ports of patient intravenous catheters. The investigators will use a new surveillance system to evaluate how well the bundle, and each component of the bundle, is working. Surveillance will identify S. aureus transmission events, and movement of S. aureus between reservoirs before, during, and after surgery (perioperative). Surveillance will map transmission events to identify actionable steps to improve the bundle. An infection control perioperative team will act on the surveillance reports to proactively address the action items, and to measure the effect of their efforts for the treatment group. The investigators will compare perioperative S. aureus transmission events for patients receiving the bundle to perioperative S. aureus transmission events for patients receiving usual care.

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age
  • Undergoing surgery (orthopedic total joint, orthopedic spine, Gynecological/Oncology, thoracic, general, hernia, colorectal, open vascular, plastic surgery and open urological)
  • Ability to sign informed consent
  • Require general or regional anesthesia

Exclusion Criteria:

  • Less than 18 years of age
  • Inability to sign informed consent
  • Procedures not included above
  • Not requiring general or regional anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard of Care
Patient will receive by mail a kit containing swab for the nares, armpit and groin.
ACTIVE_COMPARATOR: Swab kit plus povidone-iodine soap
Patient will receive by mail a kit containing swab for the nares, armpit and groin. In addition the patient will receive decolonization treatment including povidone-iodine soap for presurgical cleansing two days prior to surgery.
Device: Swab and decolonization using povidone-iodine cleansing
Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitate the Reduction of S. Aureus Tranmission
Time Frame: Up to 180 days following surgery
Compare the number of S. aureus transmission events for patients who receive the standard presurgical preparation verses patients who receive decolonization interventions.
Up to 180 days following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify the Number of Preoperative Patients Positive for S. Aureus Using Collection Kits
Time Frame: Preoperative
To identify the number of patients in the preoperative setting who test positive for S. aureus.
Preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Randy Loftus

Collaborators

RDB Bioinformatics, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2018

Primary Completion (ACTUAL)

January 1, 2021

Study Completion (ACTUAL)

January 1, 2021

Study Registration Dates

First Submitted

August 15, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (ACTUAL)

August 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201802843

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.

IPD Sharing Time Frame

IPD will be available for sharing immediately after publication and ending 5 years following article publication.

IPD Sharing Access Criteria

IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal

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

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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