Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04449705 |
| Other study ID # |
202006248 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
September 30, 2020 |
Study information
| Verified date |
June 2021 |
| Source |
University of Iowa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Surgical site infections increase patient morbidity and healthcare costs. The Centers for
Disease Control and Prevention emphasizes improved basic preventive measures to reduce
bacterial transmission and infections for patients undergoing surgery. We conducted a
previous study that showed our treatment bundle is highly effective.
Our current study planned to examine patterns/rate of S. aureus transmission to improve
feedback widespread implementation of the perioperative infection prevention program at Iowa.
The purpose of this study is to assess the fidelity of the set of interventions in
controlling perioperative S. aureus and to provide data feedback via surveillance involving
epidemiology of transmission for system optimization.
Description:
The operating room schedule will be reviewed each day by the research assistant.
At the start of each case, the technician will obtain an OR PathTrac kit and will fill out
required card indicating the OR number, the surgery date, and the type of surgery. The cards
will be placed back into the kit. Sample collection will be directed via use of the kit. The
first sample is the adjustable pressure-limiting valve and agent dial of the machine before
patient entry (measures terminal cleaning), then provider (attending and assistant) hands
after they enter but before patient interaction, then the provider nose and mouth after
induction of anesthesia and patient stabilization, then provider hands, then same
environmental sites, then provider sites again, then stopcock.
A transmission event will be defined as detection of S. aureus pathogens among 2 distinct,
epidemiologically-related reservoirs within a surveillance unit. The software platform will
process transmission dynamics in order to continually summarize the epidemiology of S. aureus
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 assistant will use the reports to
continually optimize the interventions during the observational period.
