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 tests a new hand hygiene system called SafeHaven to determine if it can reduce the spread of bacteria in operating rooms. The researchers aim to discover whether this system helps keep patients safer during surgeries by preventing infections. Participants will either use the new system or continue with standard hand hygiene practices. Suitable candidates for the trial are patients aged 18 and older who are scheduled for specific surgeries, such as orthopedic, gynecological, or heart procedures at the research center. Anesthesia providers at the center will also test the system's effectiveness. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance surgical safety practices.

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 prior data suggests that the SafeHaven Automated Hand Hygiene Device is safe for use in the operating room?

Research has shown that automated hand hygiene systems, such as SafeHaven, are generally safe and easy to use. These systems enhance hand washing by monitoring and encouraging proper techniques. They are non-invasive, meaning they don't involve entering the body or using medications.

Studies have found that systems like SafeHaven can improve hand hygiene by 85%. This improvement correlates with fewer hospital-acquired infections, suggesting they help keep people safer.

No major problems have been reported with these devices, indicating they typically don't cause harm or discomfort. The absence of a trial phase means the device is already considered safe to use, similar to other non-invasive hygiene products. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SafeHaven Automated Hand Hygiene Device because it offers a cutting-edge solution for reducing surgical site infections. Unlike the standard practice of manual hand washing or using hand sanitizers, which rely heavily on personal compliance and consistency, SafeHaven automates the hand hygiene process in the operating room. This system ensures high adherence to hygiene protocols by automatically dispensing the right amount of sanitizer at the right time, minimizing human error. By potentially increasing the consistency and reliability of hand hygiene, SafeHaven could significantly decrease infection rates, leading to safer surgical outcomes.

What evidence suggests that the SafeHaven Automated Hand Hygiene Device is effective for reducing surgical site infections?

Research has shown that automated hand hygiene systems like SafeHaven can greatly increase hand cleaning frequency. One study found that using an automated system boosted hand cleaning by 85%. In this trial, participants in the intervention arm will use the SafeHaven system, a wearable device that encourages regular hand cleaning, reducing the risk of spreading infections in hospitals. The system also employs cloud technology to monitor hand cleaning, enhancing its effectiveness in maintaining cleanliness. These improvements are particularly vital in operating rooms, where preventing infections is crucial. ^{1 2 3 4 6}

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

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]

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 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 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]

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]

Citations

1. withpower.com withpower.com/trial/phase-surgical-wound-infection-2022-e6037

Personal Hand Hygiene System for Surgical Site Infection The implementation of an automated hand hygiene monitoring system (AHHMS) combined with additional strategies led to an 85% increase in hand hygiene performance ...

2. hfmmagazine.com hfmmagazine.com/articles/4112-automated-hand-hygiene-system-evolution-continues

Automated hand-hygiene system evolution continues Vendors have reported positive results. Hagedorn notes that within the first 18 months of implementing SwipeSense to monitor hand-hygiene ...

3. owens-minor.com owens-minor.com/wp-content/uploads/2022/03/Product-card-5-19_123750_01_SafeHaven_Brochure_R14.pdf

Transforming Hand Hygiene with Wearable, Workflow- ... The SafeHaven® system combines a wearable, wireless sanitizing device with reliable cloud-based reporting to help improve hand hygiene practices and reduce HAI ...

4. infectioncontroltoday.com infectioncontroltoday.com/view/hand-hygiene-monitoring-technology-advice-product-evaluation-and-purchasing

Hand Hygiene Monitoring Technology: Advice for Product ... Patient satisfaction survey results where the patient responded "always" increased by 9 percent overall. Reference: Improving Hand Hygiene ...

5. cambridge.org cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/impact-of-an-automated-hand-hygiene-monitoring-system-combined-with-a-performance-improvement-intervention-on-hospitalacquired-infections/B0F461E64B2FF8A5A1B43B03678DDC8C

Impact of an automated hand hygiene monitoring system ... We assessed the effect of improvements in electronically measured hand hygiene adherence on the incidence of hospital-acquired infections.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32460928/

Impact of an automated hand hygiene monitoring system ... We assessed the effect of improvements in electronically measured hand hygiene adherence on the incidence of hospital-acquired infections.