A Phase 4 interventional study of Povidone Iodine 5% Soln,Top,Kit in SARS-CoV-2 Acute Respiratory Disease, sponsored by University of Iowa. Withdrawn. Open to participants aged 18 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by University of Iowa · Phase 4, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
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
Half of the patients will not receive 5% povidone iodine and will proceed with usual care.
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
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.
Time frame: 4 hours
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.
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.
Time frame: 4 hours
No study locations are listed for this record.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr
This study is withdrawn, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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