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

NCT ID: NCT04900298

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-06-30

Brief Summary

The investigators hypothesize that the use of a personal hand hygiene system (SafeHavenTM) by anesthesia providers in the adult operating room, combined with a novel infectious pathogen tracking system (OR PathTrac) will decrease participant exposure to pathologic bacteria in the adult operating room.

Detailed Description

This will be a prospective, single center, unmasked, controlled before and after study.

Intervention Arm: Use of SafeHaven hand hygiene system in the operating room

Control Arm: Standard of care hand hygiene

Operating Room Selection: Two patients (case-pair) having surgery in a serial manner in a randomly selected operating room will be evaluated for detection of pathogenic bacteria. The operating room for investigation will be randomly selected through the following process:

1. All the operating rooms with scheduled surgeries in the South Operating Rooms on a particular day will be entered into a random number generator (example: operating rooms 2, 3, 5, 7).

2. The random generator will sort these operating rooms into a rank list (example: operating rooms 5, 3, 2, 7).

3. The investigators will start at the top of this list and work down until the first operating room meeting all inclusion criteria is found (example: operating room 5 only has one surgery, operating room 3 has pediatric surgery, operating room 2 meets inclusion criteria)

4. This process will be duplicated for each case-pair

The goal of the study is to map transmission of bacteria through the operating room and compare mapping with the SafeHaven Hand Hygiene system to mapping without the SafeHaven Hand Hygiene system. Thus, case-pairs will be randomized to the same assignment. For example, subject 1 and 2 will have surgery in South Operating Room 8 and both will be randomized to the control group. The first 10 case-pairs will be assigned to the control arm and the second 10 case-pairs will be assigned to the intervention arm.

Conditions

Surgical Wound Infection; Cross Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Use of SafeHaven hand hygiene system in the operating room

Group Type: EXPERIMENTAL

SafeHaven Automated Hand Hygiene Device

Intervention Type: DEVICE

Anesthesia providers in the intervention arm will be given a personal hand hygiene device, containing 64% ethyl alcohol, which provides actionable real-time performance feedback. The personalized device will be affixed to the provider's waist and will remain there for use throughout the perioperative period. Performance feedback is given to the anesthesia provider in real time with the number of personal hand hygiene events and an hourly hand hygiene rate, which is displayed on the device. Devices will be handed out to participating providers in the preoperative bay and retrieved in the post-anesthesia care unit upon case completion.

Control Arm

Standard of care hand hygiene

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SafeHaven Automated Hand Hygiene Device

Anesthesia providers in the intervention arm will be given a personal hand hygiene device, containing 64% ethyl alcohol, which provides actionable real-time performance feedback. The personalized device will be affixed to the provider's waist and will remain there for use throughout the perioperative period. Performance feedback is given to the anesthesia provider in real time with the number of personal hand hygiene events and an hourly hand hygiene rate, which is displayed on the device. Devices will be handed out to participating providers in the preoperative bay and retrieved in the post-anesthesia care unit upon case completion.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Patients ≥ 18 years of age having surgery in an adult operating suite at the research center involving the following specialties: orthopedics/spine, orthopedics/total joint, gynecology/oncology, colorectal, open vascular, and open urological, general abdominal, acute care, cardiothoracic, and plastic/breast.

• Faculty physicians, resident physicians, or certified registered nurse anesthetists that provide care for adults having surgery at the research center.

Exclusion Criteria

• Patients with a known infection at the time of surgery.
• Prisoners
• Pregnant Women
• Patients lacking capacity to consent
• Patients with an allergy to a component of hand hygiene solution, such as ethyl alcohol
• Refusal of consent

• Refusal of consent
• Open sores of the hands
• Known skin infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgia-Pacific Consumer Products LP

UNKNOWN

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

RDB Informatics

UNKNOWN

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Brandon M Togioka

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brandon M Togioka, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brandon M Togioka, MD

Role: CONTACT

togioka@ohsu.edu

503-494-4572

Sydney Rose, MD

Role: CONTACT

rosesy@ohsu.edu

503-494-1358

Facility Contacts

Brandon M Togioka, MD

Role: primary

togioka@ohsu.edu

503-494-4572

Sarah Feller

Role: backup

fellersa@ohsu.edu

Other Identifiers

22966

Identifier Type: -

Identifier Source: org_study_id