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Completed

NCT Number: NCT06274918

Reducing ESKAPE Transmission in the Operating Room

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.

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Key information

Conditions

Surgical Procedure, Unspecified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalized Body-Worn Alcohol Dispenser

Device

This is an alcohol dispenser that will be worn on the Anesthesia Providers scrub pants, near the hip. It will be worn by both the attending physician and the resident physician/CRNA/SRNA. The device is produced by Georgia-Pacific.

Primary outcomes

  1. ESKAPE transmission events with and without the body worn device

    Time frame: 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 outcomes

  1. The epidemiology of ESKAPE transmission events

    Time frame: Up to 90 days from surgery

    To characterize the epidemiology of ESKAPE transmission with and without the device according to incidence.

  2. The epidemiology of ESKAPE transmission events

    Time frame: Up to 90 days from surgery

    To characterize the epidemiology of ESKAPE transmission with and without the device according to reservoir of origin.

  3. The epidemiology of ESKAPE transmission events

    Time frame: Up to 90 days from surgery

    To characterize the epidemiology of ESKAPE transmission with and without the device according to transmission location(s).

  4. The epidemiology of ESKAPE transmission events

    Time frame: Up to 90 days from surgery

    To characterize the epidemiology of ESKAPE transmission with and without the device according to portal of entry (stopcock).

  5. The epidemiology of ESKAPE transmission events

    Time frame: 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).

  6. 90-Day Healthcare-Associated Infections

    Time frame: 90 days following surgery

    Number of infections occurring within 90 days of surgery

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • Georgia-Pacific
  • RDB Bioinformatics

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 23, 2024
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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