Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID04900298

Reducing Intraoperative ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter Spp.) Transmission in the Adult Operating Room Using a Personal Hand Hygiene System and OR PathTrac

Led by Oregon Health and Science University · Updated on 2024-06-21

40

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

Sponsors

O

Oregon Health and Science University

Lead Sponsor

G

Georgia-Pacific Consumer Products LP

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether using a personal hand hygiene system called SafeHaven by anesthesia providers in adult operating rooms can reduce exposure to harmful bacteria known as ESKAPE pathogens during surgery. The study compares the use of this device combined with a novel tracking system, OR PathTrac, against standard hand hygiene practices to see how well they prevent bacterial transmission. This prospective, single-center, unmasked, controlled before-and-after study focuses on adult surgical patients in various specialties at one research center. Participants are assigned to one of two groups: one where anesthesia providers use the SafeHaven hand hygiene device, and a control group using standard hand hygiene care. The SafeHaven device contains 64% ethyl alcohol and offers real-time feedback on hand hygiene performance, worn on the provider's waist during surgery. Operating rooms are randomly selected for each paired case of surgeries, with the first 10 pairs assigned to the control group and the next 10 to the intervention group. Patients aged 18 to 99 undergoing surgery in specified specialties at the center will be monitored. Researchers will collect microbial cultures during the perioperative period, typically within 12 hours, to count reservoirs of ESKAPE bacteria. Additional tracking of transmission events will be done using OR PathTrac software for 30 days after surgery. The study includes monitoring hand hygiene adherence and bacterial transmission to assess the system's impact on surgical wound infection and cross infection rates.

CONDITIONS

Brief Title

Reducing Intraoperative ESKAPE Transmission Through Use of a Personal Hand Hygiene System

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older having surgery in an adult operating suite involving orthopedics/spine, orthopedics/total joint, gynecology/oncology, colorectal, open vascular, open urological, general abdominal, acute care, cardiothoracic, or plastic/breast specialties
  • Faculty physicians, resident physicians, or certified registered nurse anesthetists providing care for adults during surgery at the research center
Not Eligible

You will not qualify if you...

  • Patients with a known infection at the time of surgery
  • Prisoners
  • Pregnant women
  • Patients lacking capacity to consent
  • Patients allergic to hand hygiene solution components like ethyl alcohol
  • Refusal of consent
  • Anesthesia providers with open hand sores or known skin infections
  • Anesthesia providers refusing consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Perioperative time, typically less than 12 hours

Participants undergo surgery in selected operating rooms. Anesthesia providers in the intervention arm use a personal hand hygiene device throughout the perioperative period to reduce bacterial transmission.

1 surgery visit (in-person)

Surveillance

Duration - 30 days following surgery

Participants are monitored for bacterial transmission events using OR PathTrac software for 30 days following surgery.

Follow-up visits as per routine care

Trial Site Locations

Total: 1 location

1

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

B

Brandon M Togioka, MD

S

Sydney Rose, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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