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

NCT04900298 | Recruiting FDA Device

• 1 other identifier: 22966
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Wound Infection; Cross Infection

Outcome Measures

Primary Outcomes (1)

• Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) reservoirs identified using microbial culture collection kits

  The following reservoirs will be cultured at case start (anesthesia machine adjustable pressure limiting valve, patient nare, patient axilla, patient groin, anesthesia provider dominant hand, primary assigned anesthesia assistant) and at case end (anesthesia machine adjustable pressure limiting valve, patient nare, patient axilla, patient groin, anesthesia provider dominant hand, primary assigned anesthesia assistant, and internal lumen of intravenous tubing stopcock) within the operating room suite using a sterile collection kit.

  Perioperative Time, typically less than 12 hours

Secondary Outcomes (2)

• Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events using OR PathTrac Software.

  30 days following surgery

• Quantitate the reduction in ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) transmission events

  30 days following surgery

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Use of SafeHaven hand hygiene system in the operating room

Device: SafeHaven Automated Hand Hygiene Device

Control Arm

NO INTERVENTION

Standard of care hand hygiene

Interventions

SafeHaven Automated Hand Hygiene Device 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 Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Faculty physicians, resident physicians, or certified registered nurse anesthetists that provide care for adults having surgery at the research center.
• Refusal of consent
• Open sores of the hands
• Known skin infection

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Georgia-Pacific Consumer Products LP: collaborator
• University of Iowa: collaborator
• RDB Informatics: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection; Cross Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iatrogenic Disease; Disease Attributes

Study Officials

• Brandon M Togioka, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brandon M Togioka, MD

CONTACT

503-494-4572; togioka@ohsu.edu

Sydney Rose, MD

CONTACT

503-494-1358; rosesy@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a prospective, single center, unmasked, controlled before and after study. Two patients (case-pair) having surgery in a serial manner in a randomly selected operating room will be evaluated for the detection of pathogenic bacteria. The first twenty patients (10 case-pairs) will be enrolled in the control (standard care) arm followed by 20 patients (10 case-pairs) being enrolled in the intervention (SafeHaven) arm.

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 25, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)