Povidone Iodine Nasal Application to Prevent Intraoperative Spread of SARS-CoV-2
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About
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.
Full 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.
Sex
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Stephanie N Gibbons, BS; Randy W Loftus, MD
Data sourced from clinicaltrials.gov
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