Povidone Iodine Nasal Application to Prevent Intraoperative Spread of SARS-CoV-2

November 16, 2023 updated by: University of Iowa

Exploring the Impact of Nasal Povidone Iodine for Prevention of Intraoperative Spread of SARS-CoV-2 Nucleic Acid Particles and Assessment of Infectivity of Transmitted Particles

The primary aim is to test whether preoperative asepsis with 5% nasal povidone iodine versus no preoperative asepsis with 5% nasal povidone iodine reduces proximal and distal SARS-CoV-2 transmission in operating rooms among patients who are acutely infected with SARS-CoV-2. The secondary aim is to test viral infectivity.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Primary Objectives:

The primary aim is to test whether preoperative asepsis versus no preoperative asepsis reduces intraoperative SARS-CoV-2 transmission among patients acutely infected with SARS-CoV-2 (within 10 days of surgery).

Primary Endpoints:

Proximal and distal contamination with SARS-CoV-2 via nucleic acid detection.

Each patient will undergo induction of anesthesia and stabilization for the planned procedure. Approximately 50% of patients will have received 3M 5% povidone iodine 2 times prior to incision (each nares treated 2 times, 4 swabs, a total of 1 vial per patient) with the first time being before anesthesia administration and the second after anesthesia administration or usual care. Then, the investigators will sample locations for which the investigators detected SARS-CoV-2 transmission during the pilot: anesthesia work area reservoirs (anesthesia attending and assistant hands, patient nasopharynx, axilla and groin, and the anesthesia machine vaporizer at case end and at case start, and the patient intravenous stopcock at case end) and the operating room environment (anesthesia cart handles, anesthesia provider mouse, top of anesthesia cart, anesthesia suction cannister, circulating nurse mouse, walls at 6 feet, walls at the base of the floor, and air intake registers). A subset of all samples except patient nasopharynx, axilla, and groin at case beginning will be combined and processed together. Subsets of patient nasopharynx, axilla, and groin samples at case beginning will be combined and processed together. All samples will be stored separately. All samples will be collected before cleaning, transported to the laboratory, and analyzed using real-time PCR for viral detection. Samples will be saved for analysis of viral infectivity and for potential evaluation of each individual sample.

Secondary Objectives:

The secondary aim is to determine transmission of particles with infectivity.

Secondary Endpoints:

Proximal and distal environmental contamination with SARS-CoV-2 via viral culture.

All samples received in the laboratory will be assessed for infectivity in collaboration with Dr. Stanley Perlman, a preeminent expert in coronaviruses. Serial 1:10 dilutions of the 1mL primary collections in phosphate buffered saline (PBS) will be used to inoculate Vero E6 cells, incubating for 45 minutes at 37°C for plaque assay. Medium containing virus will be removed, and the cells allowed to incubate overnight in D10 media. Plaque counts will be determined the following day by combining 1% neutral red with 2× media plus agarose and incubating the cells for approximately 3 hours. All samples will be tested in triplicate with replicate experiments.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

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

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 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients
  • Undergoing surgery (elective, urgent, or emergent)
  • Requiring general anesthesia
  • Acutely infected (<= 10 days from diagnosis) with SARS-CoV-2

Exclusion Criteria:

  • Not general anesthesia
  • Not acutely infected (<= 10 days from diagnosis) with SARS-CoV-2
  • Allergy to povidone iodine
  • Unable to provide consent
  • Pregnant individuals

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Povidone Iodine
5% povidone iodine will be swabbed in patients' nares (experimental group), one in each nostril, twice before incision.
Drug: Povidone Iodine 5% Soln,Top,Kit
5% povidone iodine will be swabbed in patients nares of the experimental group.
Other Names:
  • MPN: 192401
  • 3M Skin and Nasal Antiseptic Preoperative Preparation
No Intervention: Usual Care
Half of the patients will not receive 5% povidone iodine and will proceed with usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of SARS-CoV-2 nucleic acid particles in proximal and distal operating room locations using real time PCR in SARS-CoV-2 acutely infected patients receiving perioperative application of nasal 5% povidone iodine.
Time Frame: 4 hours
The proximal (anesthesia attending and assistant hands, patient nasopharynx, axilla, and groin, anesthesia machine vaporizer, and patient intravenous stopcock) and distal (anesthesia cart handles, anesthesia provider mouse, top of anesthesia cart, anesthesia suction canister, circulating nurse house, walls at 6 feet and at base of the floor, and air intake registers) locations will be evaluated with real time PCR for the presence of SARS-CoV-2 nucleic acid particles. This will be evaluate for patients receiving normal care and for patients receiving nasal 5% povidone iodine preoperatively. All of the samples except for patient nasopharynx, axilla, and groin at case beginning will be pooled together and evaluated. Patient nasopharynx, axilla, and groin at case beginning will be evaluated separately.
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral load of the proximal and distal samples collected for the primary outcome will be evaluated with tissue cultures using Vero E6 cells and plaque counting.
Time Frame: 4 hours
Serial 1:10 dilutions of the 1mL primary collections in phosphate buffered saline (PBS) will be used to inoculate Vero E6 cells, incubating for 45 minutes at 37°C for plaque assay. Medium containing virus will be removed, and the cells allowed to incubate overnight in D10 media. Plaque counts will be determined the following day by combining 1% neutral red with 2x media plus agarose and incubating the cells for approximately 3 hours. All samples will be tested in triplicates with replicate experiments. The amount of plaques counted will be converted into PFU/ml as the outcome measure.
4 hours

Collaborators and Investigators

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

Sponsor

University of Iowa

Collaborators

3M

Investigators

  • Study Director: Randy W Loftus, MD, University of Iowa
  • Principal Investigator: Stephanie N Gibbons, BS, 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

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 (Estimated)

July 3, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

February 27, 2023

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202212396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share the IPD upon review of requests. Requests will be determined appropriate or not by the PI in which the PI will decide whether or not to share the data no early than 1 year following publication of the manuscript.

IPD Sharing Time Frame

Data will not be shared earlier than 1 year after publication of the manuscript and will be available for request for the following 2 years.

IPD Sharing Access Criteria

I will need to determine if the request for the data is ethical and that the data will be helpful but also not used to draw false conclusions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • 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

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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