What is the mechanism of action of this treatment?

Improved hand hygiene practices, such as those studied in the SafeHavenTM trial, are essential in preventing Surgical Site Infections (SSIs). These practices involve using alcohol-based hand rubs or soap and water to eliminate harmful bacteria on the hands of healthcare providers. By reducing the transmission of pathogens during surgical procedures, the incidence of SSIs is significantly lowered. This is crucial for SSI patients as it enhances recovery outcomes, reduces the need for extended antibiotic use, and minimizes the risk of severe complications like sepsis.

What side effects are associated with this type of intervention?

The most common treatments for Surgical Site Infections (SSIs) involving improved hand hygiene practices, such as the use of alcohol-based hand rubs or antiseptic solutions, can lead to side effects like skin irritation, dryness, and dermatitis. Rarely, allergic reactions to specific ingredients in these products may occur. Overuse of antiseptics can also contribute to the development of resistant bacterial strains.

What prior FDA approvals exist?

The FDA has approved various treatments for Surgical Site Infections (SSIs), including antibiotics such as cephalosporins, penicillins, and vancomycin, which are commonly used to treat or prevent infections. Additionally, antiseptic solutions like chlorhexidine and povidone-iodine are approved for preoperative skin preparation to reduce the risk of SSIs. While specific FDA approvals for hand hygiene systems like SafeHavenTM are not detailed, the emphasis on improved hand hygiene practices aligns with general infection control measures endorsed by the FDA to prevent SSIs.

What other types of research exist?

Promising alternatives to SafeHavenTM for improving hand hygiene practices and reducing SSIs include: 1) Alcohol-based handrubs, which have been shown to be as effective as traditional soap and water in preventing SSIs in surgical settings. 2) Multimodal hand hygiene interventions tailored to specific hospital settings, as recommended by the World Health Organization, which have improved hand hygiene adherence among healthcare workers. 3) Antimicrobial stewardship interventions, which optimize the use of prophylactic antibiotics in surgical procedures to prevent SSIs.

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Personal Hand Hygiene System for Surgical Site Infection (ESKAPE Trial)

N/A

Recruiting

Led By Brandon M Togioka, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

Patients with a known infection at the time of surgery

Refusal of consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days following surgery

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include skin irritation or allergic reactions due to components of the hand hygiene solution such as ethyl alcohol.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an infection at the time of my surgery.

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I have not refused to give my consent for participation.

Select...

I am unable to give consent due to my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days following surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Acinetobacter

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

Use of SafeHaven hand hygiene system in the operating room

Group II: Control ArmActive Control1 Intervention

Standard of care hand hygiene

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Improved hand hygiene practices, such as those studied in the SafeHavenTM trial, are essential in preventing Surgical Site Infections (SSIs). These practices involve using alcohol-based hand rubs or soap and water to eliminate harmful bacteria on the hands of healthcare providers. By reducing the transmission of pathogens during surgical procedures, the incidence of SSIs is significantly lowered. This is crucial for SSI patients as it enhances recovery outcomes, reduces the need for extended antibiotic use, and minimizes the risk of severe complications like sepsis.

Cluster-randomized, crossover trial of the efficacy of plain soap and water versus alcohol-based rub for surgical hand preparation in a rural hospital in Kenya.