Povidone Iodine Nasal Application to Prevent Intraoperative Spread of SARS-CoV-2
NCT ID: NCT05745467
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2024-07-03
2026-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nasal Decolonization for Orthopedic Trauma Patients
NCT04146116
Comparison of Two Preoperative Antiseptic Solutions Alcohol Based in Abdominal Elective Surgeries
NCT03859908
Reducing Perioperative S. Aureus Transmission
NCT03638947
PVP Iodine vs Chlorhexidine in Alcohol for Disinfection of the Surgical Site
NCT03685604
Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics
NCT00692484
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Povidone Iodine
5% povidone iodine will be swabbed in patients' nares (experimental group), one in each nostril, twice before incision.
Povidone Iodine 5% Soln,Top,Kit
5% povidone iodine will be swabbed in patients nares of the experimental group.
Usual Care
Half of the patients will not receive 5% povidone iodine and will proceed with usual care.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Povidone Iodine 5% Soln,Top,Kit
5% povidone iodine will be swabbed in patients nares of the experimental group.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Undergoing surgery (elective, urgent, or emergent)
* Requiring general anesthesia
* Acutely infected (\<= 10 days from diagnosis) with SARS-CoV-2
Exclusion Criteria
* Not acutely infected (\<= 10 days from diagnosis) with SARS-CoV-2
* Allergy to povidone iodine
* Unable to provide consent
* Pregnant individuals
18 Years
105 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
3M
INDUSTRY
University of Iowa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Randy W Loftus, MD
Role: STUDY_DIRECTOR
University of Iowa
Stephanie N Gibbons, BS
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202212396
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.