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

Sponsor

Randy Loftus (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05745467

Collaborator

3M (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Acute Respiratory Disease	Drug: Povidone Iodine 5% Soln,Top,Kit	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Sixty-two adult patients with acute SARS-CoV-2 infection undergoing surgery (elective, urgent or emergent) at the University of Iowa will be randomized 1:1 to each of two groups, 3M 5% povidone iodine (treatment) or usual care. Vaccination status will be recorded. Patients randomized to treatment will receive 2 doses of 3M 5% nasal povidone iodine preoperatively given that this dose is commonly used to prevent surgical site infections.7 The first dose will occur prior to induction of anesthesia and the second dose will occur after induction of anesthesia and patient stabilization (in preoperative holding for elective patients or in the operating room for urgent/emergent surgery) but before incision and will involve application to each nares using 2 swabs per nares, 4 swabs per patient.Sixty-two adult patients with acute SARS-CoV-2 infection undergoing surgery (elective, urgent or emergent) at the University of Iowa will be randomized 1:1 to each of two groups, 3M 5% povidone iodine (treatment) or usual care. Vaccination status will be recorded. Patients randomized to treatment will receive 2 doses of 3M 5% nasal povidone iodine preoperatively given that this dose is commonly used to prevent surgical site infections.7 The first dose will occur prior to induction of anesthesia and the second dose will occur after induction of anesthesia and patient stabilization (in preoperative holding for elective patients or in the operating room for urgent/emergent surgery) but before incision and will involve application to each nares using 2 swabs per nares, 4 swabs per patient.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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. [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.

Secondary Outcome Measures

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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 105 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Randy Loftus
3M

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Randy Loftus, Associate Professor of Anesthesia, University of Iowa

ClinicalTrials.gov Identifier:

NCT05745467

Other Study ID Numbers:

123456789

First Posted:

Feb 27, 2023

Last Update Posted:

Feb 27, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Randy Loftus, Associate Professor of Anesthesia, University of Iowa

Additional relevant MeSH terms:

Respiration Disorders

Respiratory Tract Diseases

Povidone-Iodine

Povidone

Study Results

No Results Posted as of Feb 27, 2023