Reducing ESKAPE Transmission in the Operating Room

Recruiting

• Conditions: Surgical Procedure, Unspecified
• Interventions: Device: Personalized Body-Worn Alcohol Dispenser

• Registration Number: NCT06274918
• Lead Sponsor: University of Iowa

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.

Study Timeline

• Study First Submitted: 2023-01-31
• Study Start: 2023-02-01
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Study First Posted: 2024-02-23
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Adult patients undergoing surgery requiring general anesthesia and peripheral IV and/or central line placement.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Personalized body worn alcohol dispenser	Personalized Body-Worn Alcohol Dispenser	Anesthesia providers (attending anesthesiologist and their assistant (resident physician/Certified-Registered Nurse Anesthetist (CRNA), or student nurse assistant (SRNA) will receive a personalized, body worn alcohol dispenser in addition to usual hand hygiene devices/products for hand decontamination during surgery requiring general anesthesia.

Primary Outcome Measures

Name	Time	Method
ESKAPE transmission events with and without the body worn device	Up to 96 hours from the surgial procedure	Reduce the number of Enterococcus, Staphylococcus aureus, Pseudomonas, and other gram-negative (i.e., Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events

Secondary Outcome Measures

Name	Time	Method
The epidemiology of ESKAPE transmission events	Up to 90 days from surgery	To characterize the epidemiology of ESKAPE transmission with and without the device according to mode (within or between-case).
90-Day Healthcare-Associated Infections	90 days following surgery	Number of infections occurring within 90 days of surgery

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States