Personal Hand Hygiene System for Surgical Site Infection

(ESKAPE Trial)

Overseen By Brandon M Togioka, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Known infection, Prisoners, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

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.

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 4 5}

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 6 7}

Who Is on the Research Team?

Brandon M Togioka, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SafeHaven Automated Hand Hygiene Device

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.

How Is the Trial Designed?

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

SafeHaven Automated Hand Hygiene Device is already approved in United States for the following indications:

Approved in United States as SafeHaven for:

• Prevention of intraoperative transmission of pathologic bacteria

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Georgia-Pacific Consumer Products LP

Collaborator

Trials

1

Recruited

40+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

RDB Informatics

Collaborator

Trials

1

Recruited

40+

Published Research Related to This Trial

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]

The automated hand hygiene compliance system (HHCS) significantly outperformed human observers in tracking hand hygiene events, recording 632,404 events compared to just 480 by humans, and helped the hospital achieve over 95% compliance rates.

While the HHCS showed potential in reducing rates of multidrug-resistant organisms and certain healthcare-associated infections, these reductions were not statistically significant, indicating that further research is needed to fully understand its impact on infection rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An automated hand hygiene compliance system is associated with improved monitoring of hand hygiene. McCalla, S., Reilly, M., Thomas, R., et al.[2018]

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]

The pilot study evaluated an electronic hand hygiene surveillance device in a 700-bed hospital, showing that direct observation revealed a hand hygiene compliance rate of only 32.3% among healthcare workers, indicating a need for improved practices.

The electronic monitoring system demonstrated high accuracy, capturing 98% of room entries and 95% of dispenser use, suggesting it is a feasible and effective tool for ongoing monitoring of hand hygiene compliance in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An electronic hand hygiene surveillance device: a pilot study exploring surrogate markers for hand hygiene compliance. Sahud, AG., Bhanot, N., Radhakrishnan, A., et al.[2022]

A systematic review of 42 articles found that while various electronic systems for monitoring hand hygiene exist, less than 20% of studies evaluated their efficiency or accuracy, indicating a gap in reliable data.

There is currently insufficient evidence to recommend specific automated hand hygiene monitoring systems, highlighting the need for future research on their accuracy, effectiveness, and cost-effectiveness before widespread adoption in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated and electronically assisted hand hygiene monitoring systems: a systematic review. Ward, MA., Schweizer, ML., Polgreen, PM., et al.[2022]

Citations

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]