University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
NCT Number: NCT04443803
In a case-series analysis, up to 20 patients undergoing elective or urgent/emergent surgery that are COVID-19 positive will be approached for patient consent.
OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) collection kits will be utilized for sampling of 48 sampled time/locations per patient. Patient sampling locations will include the nasopharynx and oropharynx. Operating room environmental locations will include areas in the patient care arena such as the anesthesia machine. Samples of each location will be obtained before and after treatment with UV-C (Helios, Surfacide), germicidal, ultraviolet light and other infection control practices that are currently in place, such as utilization of preoperative chlorhexidine wipes, nasal iodine, improved hand hygiene, and improved vascular care.
UV-C light for environmental cleaning is not regulated by the FDA.
Samples will be processed by RT-PCR for presence of SARS-CoV-2 nucleic acid. Positive samples will be sent to Dr. Stanley Perlman's lab to assess viability. Samples will also be assessed for S. aureus as a process control. We will characterize the epidemiology of perioperative SARS-CoV-2 spread as a quality improvement initiative to improve our current perioperative infection control bundle and to serve as the platform for national dissemination of a perioperative COVID-19 defense strategy.
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Notify Me18 year–120 year
All sexes
Observational
Iowa City, Iowa, 52242, United States
The operating room schedule will be reviewed each day by a research assistant for COVID-19 positive patients. Additionally, the research assistant will receive a page for every emergency surgery that takes place in the OR.
OR PathTrac collection kits will be utilized for sampling of 48 specific locations/times throughout each case. These samples include:
A transmission event will be defined as 2 samples with detection of SARS-CoV-2 by RT-PCR, with samples obtained from 2 distinct, epidemiologically-related reservoirs within a surveillance unit. The OR PathTrac software platform will process transmission dynamics in order to continually summarize the epidemiology of SARS-CoV transmission, with results updated daily as case-pair data is continually entered into the program. This information will be continually displayed to identify the most common reservoir of origin, the most common transmission locations (vectors), and involvement of key portals of entry (stopcocks). These will become improvement targets with feedback provided via automated failure mode analysis reports. The research assistants will use the reports to continually optimize the interventions during the observational period. The incidence and epidemiology of transmission will be mapped before and after UV-C treatment and positive samples for SARS-CoV-2 examined for viability by a UIHC laboratory.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 24 hours
Sars-CoV-2 transmission event
Randy Loftus
Other
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