Recruiting

SafeHavenTM & OR PathTrac

Sponsor:

Oregon Health and Science University

Code:

NCT04900298

Conditions

Surgical Wound Infection

Cross Infection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SafeHaven Automated Hand Hygiene Device

Study Details

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

Study ID

NCT04900298

Start date

Jan 1, 2022

Status verified date

Jun, 2024

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Patient 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.

Patient 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

Anesthesia Provider Inclusion Criteria:

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

Anesthesia Provider Exclusion Criteria:

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Use of SafeHaven hand hygiene system in the operating room

no intervention: Control Arm

Standard of care hand hygiene

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.

Primary outcome measure

  • Number of ESKAPE (Enterococcus, S. Aureus, Klebsiella, Acinetobacter, Pseudomonas, and Enterobacter spp.) reservoirs identified using microbial culture collection kits [ Time Frame: Perioperative Time, typically less than 12 hours ]

Central Contacts and Locations

Central contacts

Brandon M Togioka, MD

503-494-4572togioka@ohsu.edu

Sydney Rose, MD

503-494-1358rosesy@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Brandon M Togioka, MD

503-494-4572togioka@ohsu.edu

Sarah Feller

fellersa@ohsu.edu

Principal Investigator:

Brandon M Togioka, MD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Jun 21, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-06-21.