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

NCT05745467 | Withdrawn Phase 4

• 1 other identifier: 202212396
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

SARS-CoV-2 Acute Respiratory Disease

Keywords

General anesthetic; povidone iodine; transmission; infectivity

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• 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

Study Arms (2)

Povidone Iodine

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Half of the patients will not receive 5% povidone iodine and will proceed with usual care.

Interventions

Povidone Iodine 5% Soln,Top,Kit DRUG

5% povidone iodine will be swabbed in patients nares of the experimental group.

Also known as: MPN: 192401, 3M Skin and Nasal Antiseptic Preoperative Preparation

Povidone Iodine

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Iowa: lead
• 3M: collaborator

Related Publications (14)

• Dexter F, Parra MC, Brown JR, Loftus RW. Perioperative COVID-19 Defense: An Evidence-Based Approach for Optimization of Infection Control and Operating Room Management. Anesth Analg. 2020 Jul;131(1):37-42. doi: 10.1213/ANE.0000000000004829.

  PMID: 32217947 BACKGROUND

• Loftus RW, Dexter F, Goodheart MJ, McDonald M, Keech J, Noiseux N, Pugely A, Sharp W, Sharafuddin M, Lawrence WT, Fisher M, McGonagill P, Shanklin J, Skeete D, Tracy C, Erickson B, Granchi T, Evans L, Schmidt E, Godding J, Brenneke R, Persons D, Herber A, Yeager M, Hadder B, Brown JR. The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201934. doi: 10.1001/jamanetworkopen.2020.1934.

  PMID: 32219407 BACKGROUND

• Loftus RW, Dexter F, Robinson ADM. High-risk Staphylococcus aureus transmission in the operating room: A call for widespread improvements in perioperative hand hygiene and patient decolonization practices. Am J Infect Control. 2018 Oct;46(10):1134-1141. doi: 10.1016/j.ajic.2018.04.211. Epub 2018 Jun 12.

  PMID: 29907449 BACKGROUND

• Loftus RW, Dexter F, Robinson ADM. Methicillin-resistant Staphylococcus aureus has greater risk of transmission in the operating room than methicillin-sensitive S aureus. Am J Infect Control. 2018 May;46(5):520-525. doi: 10.1016/j.ajic.2017.11.002. Epub 2018 Jan 4.

  PMID: 29307750 BACKGROUND

• Loftus RW, Dexter F, Robinson ADM, Horswill AR. Desiccation tolerance is associated with Staphylococcus aureus hypertransmissibility, resistance and infection development in the operating room. J Hosp Infect. 2018 Nov;100(3):299-308. doi: 10.1016/j.jhin.2018.06.020. Epub 2018 Jun 30.

  PMID: 29966756 BACKGROUND

• Loftus RW, Koff MD, Brown JR, Patel HM, Jensen JT, Reddy S, Ruoff KL, Heard SO, Yeager MP, Dodds TM. The epidemiology of Staphylococcus aureus transmission in the anesthesia work area. Anesth Analg. 2015 Apr;120(4):807-18. doi: 10.1213/ANE.0b013e3182a8c16a.

  PMID: 24937345 BACKGROUND

• Robinson ADM, Dexter F, Renkor V, Reddy S, Loftus RW. Operating room PathTrac analysis of current intraoperative Staphylococcus aureus transmission dynamics. Am J Infect Control. 2019 Oct;47(10):1240-1247. doi: 10.1016/j.ajic.2019.03.028. Epub 2019 Apr 27.

  PMID: 31036398 BACKGROUND

• Wu S, Wang Y, Jin X, Tian J, Liu J, Mao Y. Environmental contamination by SARS-CoV-2 in a designated hospital for coronavirus disease 2019. Am J Infect Control. 2020 Aug;48(8):910-914. doi: 10.1016/j.ajic.2020.05.003. Epub 2020 May 12.

  PMID: 32407826 BACKGROUND

• Wu J, Huang Y, Tu C, Bi C, Chen Z, Luo L, Huang M, Chen M, Tan C, Wang Z, Wang K, Liang Y, Huang J, Zheng X, Liu J. Household Transmission of SARS-CoV-2, Zhuhai, China, 2020. Clin Infect Dis. 2020 Nov 19;71(16):2099-2108. doi: 10.1093/cid/ciaa557.

  PMID: 32392331 BACKGROUND

• Loftus RW, Dexter F, Parra MC, Brown JR. In Response: 'Perioperative COVID-19 Defense: An Evidence-Based Approach for Optimization of Infection Control and Operating Room Management'. Anesth Analg. 2020 Jul;131(1):e27-e28. doi: 10.1213/ANE.0000000000004854. No abstract available.

  PMID: 32250978 BACKGROUND

• Chin AWH, Chu JTS, Perera MRA, Hui KPY, Yen HL, Chan MCW, Peiris M, Poon LLM. Stability of SARS-CoV-2 in different environmental conditions. Lancet Microbe. 2020 May;1(1):e10. doi: 10.1016/S2666-5247(20)30003-3. Epub 2020 Apr 2. No abstract available.

  PMID: 32835322 BACKGROUND

• Wagner JA, Dexter F, Greeley DG, Schreiber K. Operating room air delivery design to protect patient and surgical site results in particles released at surgical table having greater concentration along walls of the room than at the instrument tray. Am J Infect Control. 2021 May;49(5):593-596. doi: 10.1016/j.ajic.2020.10.003. Epub 2020 Oct 9.

  PMID: 33039512 BACKGROUND

• Loftus RW, Dexter F, Evans LC, Robinson ADM, Odle A, Perlman S. An assessment of the impact of recommended anesthesia work area cleaning procedures on intraoperative SARS-CoV-2 contamination, a case-series analysis. J Clin Anesth. 2021 Oct;73:110350. doi: 10.1016/j.jclinane.2021.110350. Epub 2021 May 25. No abstract available.

  PMID: 34098391 BACKGROUND

• STONE JD, BURNET FM. The action of halogens on influenza virus with special reference to the action of iodine vapour on virus mists. Aust J Exp Biol Med Sci. 1945;23:205-12. doi: 10.1038/icb.1945.32. No abstract available.

  PMID: 21006104 BACKGROUND

MeSH Terms

Interventions

Povidone-Iodine

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Randy W Loftus, MD

  University of Iowa

  STUDY DIRECTOR

• Stephanie N Gibbons, BS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 27, 2023
• Study Start: July 3, 2024
• Primary Completion: July 1, 2025
• Study Completion: April 1, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.