Personal Hand Hygiene System for Surgical Site Infection

(ESKAPE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Brandon M Togioka, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Oregon Health and Science University

Disqualifiers: Known infection, Prisoners, Pregnant, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a new hand cleaning and germ tracking system to reduce infections in adult surgery patients. The goal is to ensure doctors have cleaner hands and to monitor harmful bacteria in the operating room.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment SafeHaven Automated Hand Hygiene Device for preventing surgical site infections?

Research shows that automated hand hygiene systems can improve hand hygiene practices, which are crucial for preventing infections in healthcare settings. These systems, by monitoring and providing feedback, have been associated with better hand hygiene compliance and reduced healthcare-associated infections. ^{1 2 3 4 5}

How is the SafeHaven Personal Hand Hygiene System different from other treatments for surgical site infections?

The SafeHaven Personal Hand Hygiene System is unique because it uses an automated and electronic system to monitor and improve hand hygiene compliance, which is crucial for preventing surgical site infections. Unlike traditional methods, it involves sensors and badges to track hand hygiene events, providing real-time feedback to healthcare workers. ^{1 2 3 6 7}

Research Team

Brandon M Togioka, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for adult anesthesia providers and patients undergoing certain surgeries at the research center. Providers must be involved in adult surgeries, while patients need to be adults having specific types of surgery like orthopedics or cardiothoracic. Excluded are those with open hand sores, prisoners, pregnant women, anyone unable to consent, known infections at surgery time, refusal to consent, skin infections or allergies to hand hygiene solutions.

Inclusion Criteria

I am 18 or older and having surgery in one of the listed specialties at the research center.

Exclusion Criteria

I have an infection at the time of my surgery.

Patients with an allergy to a component of hand hygiene solution, such as ethyl alcohol

Pregnant Women

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Perioperative

Use of SafeHaven hand hygiene system or standard care hand hygiene during surgery; microbial cultures collected at case start and end

Less than 12 hours

1 visit (in-person)

Follow-up

Participants are monitored for ESKAPE pathogen transmission events using OR PathTrac software

30 days

Treatment Details

Interventions

• SafeHaven Automated Hand Hygiene Device (Other)

Trial Overview The study tests a personal hand hygiene system called SafeHavenTM used by anesthesia providers during operations. It aims to reduce exposure to harmful bacteria in the operating room when combined with an infectious pathogen tracking system named OR PathTrac.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

Use of SafeHaven hand hygiene system in the operating room

Group II: Control Arm Active Control 1 Intervention

Standard of care hand hygiene

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

John Hunter

Oregon Health and Science University

Chief Medical Officer since 2024

MD, specific details unavailable

Ann Madden Rice

Oregon Health and Science University

Chief Executive Officer

FACHE certification, extensive leadership experience in academic health centers

Georgia-Pacific Consumer Products LP

Collaborator

Trials

1

Recruited

40+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Dr. Afable

University of Iowa

Chief Medical Officer since 2005

MD from Loyola Stritch School of Medicine, MPH from the University of Illinois

Joel Harris

University of Iowa

Chief Executive Officer since 2023

B.A. in Economics from the University of Iowa, Post-baccalaureate Certificate in Narrative Communications from Northwestern University

RDB Informatics

Collaborator

Trials

1

Recruited

40+

Findings from Research

An automated monitoring and feedback system implemented in a community hospital led to a significant increase in hand hygiene events in inpatient units, with an average increase of 0.17 events per patient-hour after feedback was provided.

Despite the positive results in inpatient settings, outpatient units did not show significant changes in hand hygiene performance, highlighting the need for tailored strategies in different healthcare environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and impact of an automated group monitoring and feedback system to promote hand hygiene among health care personnel. Conway, LJ., Riley, L., Saiman, L., et al.[2021]

The implementation of an automated hand hygiene monitoring system (AHHMS) combined with additional strategies led to an 85% increase in hand hygiene performance rates in a 93-bed hospital, indicating that technology alone is not enough without supportive measures.

While the AHHMS helped reduce non-Clostridioides difficile healthcare-associated infections (HAIs) by 56%, the increase in C. difficile infections by 60% suggests that careful monitoring and additional strategies are needed to manage all types of infections effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an automated hand hygiene monitoring system and additional promotional activities on hand hygiene performance rates and healthcare-associated infections. Boyce, JM., Laughman, JA., Ader, MH., et al.[2020]

The installation of electronic hand hygiene (HH) monitoring devices significantly improved compliance among healthcare practitioners, as observed through increased alcohol rub usage and monitoring data.

While the devices raised awareness and encouraged better HH practices, some practitioners expressed irritation and concerns about 'gaming the system', which could undermine the overall effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the use of an electronic hand hygiene monitoring and prompt device: influence and acceptability. Dyson, J., Madeo, M.[2022]

A comprehensive hand hygiene program in a hospital setting, involving over 160,000 observations from 2011 to 2019, maintained compliance rates above 95%, highlighting its effectiveness in promoting infection prevention.

Common reasons for hand hygiene misses included 'touching self' and 'touching phone', which were identified through thematic analysis, allowing for targeted education and improved communication among healthcare staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The power of feedback: Implementing a comprehensive hand hygiene observer program. Wilson, KB., Satchell, L., Smathers, SA., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation and impact of an automated group monitoring and feedback system to promote hand hygiene among health care personnel. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of an automated hand hygiene monitoring system and additional promotional activities on hand hygiene performance rates and healthcare-associated infections. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Investigating the use of an electronic hand hygiene monitoring and prompt device: influence and acceptability. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

An automated hand hygiene compliance system is associated with improved monitoring of hand hygiene. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The power of feedback: Implementing a comprehensive hand hygiene observer program. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

An electronic hand hygiene surveillance device: a pilot study exploring surrogate markers for hand hygiene compliance. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Automated and electronically assisted hand hygiene monitoring systems: a systematic review. [2022]