Clinical trial NCT06274918: Reducing ESKAPE Transmission in the Operating Room
Official title: Reducing Intraoperative ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter Spp.) Transmission Via Use of an Evidence-Based, Hand Hygiene Program Optimized by OR PathTrac
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedure, Unspecified
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: RDB Bioinformatics
name: Georgia-Pacific
First posted: 2024-02-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing surgery requiring general anesthesia and intravascular access.

Brief summary: This study is designed to examine the impact of a personalized, body worn alcohol dispenser on the epidemiology of ESKAPE transmission in the anesthesia work area for patients undergoing surgery requiring general anesthesia.

Detailed description: A solid body of published and preliminary evidence leveraging systematic phenotypic and whole cell genome analysis and innovative surveillance technology has provided great insight into the epidemiology of perioperative bacterial transmission and healthcare-associated infection (HAI) development. This work has led us to three primary assertions that serve as the foundation of our scientific premise: 1) Further progress towards HAI prevention is needed, 2) Prevention of perioperative ESKAPE transmission is an important improvement target, and 3) An evidence-based, multi-faceted program can reduce perioperative ESKAPE transmission. Further work to generate intraoperative hand hygiene improvement is indicated. We hypothesize that the proposed program will generate sustained reductions in OR ESKAPE exposure and S. aureus transmission that will lead to sustained reductions in perioperative HAIs.

Eligibility criteria: Inclusion Criteria: Adult patients undergoing surgery requiring general anesthesia and peripheral IV and/or central line placement.

Exclusion Criteria:

Pediatric patient, not requiring general anesthesia and/or IV/central line placement.

Primary outcomes:
measure: ESKAPE transmission events with and without the body worn device
timeFrame: Up to 96 hours from the surgial procedure
Secondary outcomes:
measure: The epidemiology of ESKAPE transmission events
timeFrame: Up to 90 days from surgery
measure: The epidemiology of ESKAPE transmission events
timeFrame: Up to 90 days from surgery
measure: The epidemiology of ESKAPE transmission events
timeFrame: Up to 90 days from surgery
measure: The epidemiology of ESKAPE transmission events
timeFrame: Up to 90 days from surgery
measure: The epidemiology of ESKAPE transmission events
timeFrame: Up to 90 days from surgery
measure: 90-Day Healthcare-Associated Infections
timeFrame: 90 days following surgery
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Andrew Pugely, MD
role: PRINCIPAL_INVESTIGATOR
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