Improving Case Selection for Perioperative S. Aureus Transmission Surveillance to Reduce Surgical Site Infections

July 6, 2021 updated by: Randy Loftus
The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices. The second patient in the dyad will receive usual care. Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits. The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events. Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures. It also identifies actionable steps to improve the bundle. The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Patients undergoing planned oncologic gynecological and plastic surgery will be entered as dyads into a worksheet each day that will rank and select the optimal cases. The research assistants consent both patients in the dyad to the study while they are in the Day of Surgery Admissions area. The first patient in the dyad will receive the bundle, which includes patient decolonization methods, environmental cleaning in the OR, a hand hygiene system located on the IV pole for the anesthesia provider, and intravascular catheter and syringe tip disinfection practices. The second patient in the dyad will receive usual care. Both patients will be surveyed by obtaining swab samples at the beginning and end of the surgery using the OR PathTrac kits. The OR PathTrac kits are obtained from and analyzed for S. aureus isolates by RDB Bioinformatics. The OR PathTrac software (RDB Bioinformatics, Omaha, NE 68154) uses algorithms to guide analysis of the S. aureus isolates and to identify transmission events. Transmission stories are processed by the software to generate transmission maps that identify improvement successes and failures. It also identifies actionable steps to improve the bundle. The perioperative infection control team then uses this information to continually optimize the bundle, and the software to measure the effect.

Study Type

Observational

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

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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled to undergo oncologic gynecological and plastic surgery requiring general/regional anesthesia.

Description

Inclusion Criteria:

  • Patients scheduled to undergo oncologic gynecological and plastic surgery requiring general/regional anesthesia.
  • informed, written consent.

Exclusion Criteria:

  • Patients <18 years of age.
  • Patients scheduled to undergo procedures outside of the surgical service lines listed above.
  • Patients not requiring general or regional anesthesia.
  • Patients who have a documented allergy or have an allergic reaction to to iodine, shellfish, or chlorhexidine.
  • Patients who have not provided informed, written consent.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
First patient in the case pair
This patient will receive the treatment bundle. S. aureus transmission surveillance will be conducted.
Other: Treatment Bundle (as defined below)
Patient decolonization within one hour of incision, improved environmental cleaning (frequency and quality, including but not limited to targeted use of no touch disinfection with UV-C treatment), provider hand hygiene leveraging proximity, improved catheter disinfection, and surveillance optimization.
Second patient in the case pair
This patient will receive usual care. S. aureus transmission surveillance will be conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time course in S. aureus transmission decline with the intervention.
Time Frame: Up to 52 weeks
S. aureus transmission events by time.
Up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systematic selection of sequential cases in operating rooms for surveillance to reduce sample size and increase power.
Time Frame: Up to 52 weeks
The outcome is the proportional reduction in the necessary sample size of pairs of cases achieved by systematic selection of sample cases as compared with random selection.
Up to 52 weeks

Collaborators and Investigators

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

Sponsor

Randy Loftus

Collaborators

RDB Bioinformatics

Investigators

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

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)

March 9, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 6, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201911589

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared upon written request and reviewed by the principal investigator for consideration.

IPD Sharing Time Frame

Upon request and evaluation, if approved by the PI for release, at least one year from publication date.

IPD Sharing Access Criteria

Submitted research protocol approved by the principal investigator, Dr. Loftus

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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