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Mayo Clinic Pulsed Xenon UV Room Disinfection Study Reports 47% Reduction in C.diff. Infection Rates

 

Even with the world’s most robust infection prevention strategy and protocols, the Mayo Clinic wanted to further reduce its patients’ risk for contracting C.diff and conducted a controlled study to evaluate the effectiveness of Xenex Disinfection Systems’ pulsed xenon ultraviolet (UV) light room disinfection technology. The study, published in the American Journal of Infection Control, found that adding pulsed xenon UV disinfection to the hospital’s disinfection efforts resulted in a 47% reduction in C.diff infection rates on the intervention units that has been sustained for two years. In addition, the facility saw an increase in patient satisfaction scores for environmental cleanliness and a 52% reduction in Vancomycin-resistant enterococci (VRE) infection rates.

Based on the significant C.diff infection rate reductions in the intervention units, the Mayo Clinic expanded pulsed xenon UV room disinfection to 14 additional hospital units with high rates of C.diff infection utilizing 12 robots. This wide-scale implementation resulted in a facility-wide reduction in its Standardized Infection Rate (SIR) from 0.774 to 0.571. SIR rates are used by the Centers for Medicare & Medicaid Services (CMS) to calculate hospital reimbursement.

Many hospital patients, especially those on antibiotics, are susceptible to C.diff, which can live for up to five months on surfaces in the hospital. A person with C.diff may contaminate their hospital room and bathroom, leaving C.diff spores on the walls, handles and other high-touch surfaces. These spores can be easily transferred to the next patient or healthcare worker in that room. For this study, the Mayo Clinic deployed two Xenex LightStrike™ Germ-Zapping Robots™ that utilize intense pulsed xenon UV light to quickly destroy pathogens like C.diff and VRE that may be lurking on high-touch surfaces in a room, such as bedrails, tray tables and doorknobs. The robot is easy to use and does not require warm-up or cool-down time, so it’s easily transported from room to room.

In the controlled trial, the first of its kind using pulsed xenon UV disinfection technology, three hospital units (two hematology and bone marrow transplant units and one medical-surgical unit) were designated for pulsed xenon UV intervention, and three units with similar patient populations served as control units. Because of the high C.diff infection rates, all patient rooms on the targeted units were cleaned with bleach daily and at terminal cleaning. In addition to tracking C.diff infection rates, hand hygiene, isolation compliance, and antimicrobial usage were followed on all the units. The only difference in the infection control programs between the controlled units and intervention units was the addition of LightStrike pulsed xenon UV disinfection. LightStrike robots were used after terminal cleaning in 85% of all discharges on the targeted intervention units.

“The Mayo Clinic has a world class infection prevention program that is extremely well-run and well monitored. Their success in reducing C.diff rates is strong evidence that pulsed xenon UV room disinfection can be a very effective tool in a hospital’s infection prevention bundle,” said Dr. Mark Stibich, Chief Scientific Officer at Xenex. “This is very exciting research for several reasons. First, the hospital achieved and sustained lower C.diff rates. Second, hospitals may be confused about the different kinds of UV technologies and their effectiveness, especially after a previous study using mercury UV devices did not show a reduction in C.diff infection rates. This data – and the story of how the Mayo Clinic achieved success in a controlled trial – demonstrates that Xenex’s pulsed xenon UV disinfection technology should be added to the infection prevention bundle as standard of care to enhance patient safety.”

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CLINICAL TRIAL IN PROGRESS 

Pulsed UV Xenon Disinfection to Prevent Resistant Healthcare Associated Infection

Recruitment Status : Recruiting

First Posted : November 21, 2017
Last Update Posted : November 27, 2018

ClinicalTrials.gov Identifier: NCT03349268

Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349268

 

Contacts
Contact: Keith S. Kaye, MD, MPH 734-615-1901 keithka@med.umich.edu
Contact: Jolene E Daniel 734-615-1901 jolened@med.umich.edu

 

Locations
United States, Michigan
Detroit Medical Center Recruiting
Detroit, Michigan, United States, 48205
Contact: Paul Kilgore, MD    313-577-1215    paul.kilgore@wayne.edu
Sponsors and Collaborators
University of Michigan
Agency for Healthcare Research and Quality (AHRQ)
Xenex Disinfection Services LLC
Detroit Medical Center
Henry Ford Health System
TEMPVA Research Group, Inc.
Wayne State University
Investigators
Principal Investigator: Keith S. Kaye, MD, MPH University of Michigan

STUDY DESCRIPTION:

Brief Summary:

The objective is to conduct a prospective, sham controlled, double-blinded, interventional crossover trial to compare standard terminal cleaning plus PX-UV (intervention) with standard terminal cleaning plus sham PX-UV (control) with crossover at 12 months, following a 6-month washout period. Outcome measures include the rates of HAIs, as well as the recurrence of genetically identical clinical strains of HAIs among patients on study units. The study will be conducted in 2 hospitals covering 16 total hospital units at Detroit Medical Center. Our central hypothesis is that the addition of PX-UV to standard terminal cleaning will be associated with a significant reduction in the rate of HAIs, as well as a reduction in the recovery of genetically identical strains of MDROs. The impact of PX-UV disinfection on rates of HAIs on study units will be determined by comparing rates of HAIs on a) study units where PX-UV is added to standard terminal cleaning practices to b) units where a sham UV disinfection system is added to standard terminal cleaning; and by comparing rates of HAIs on the same medical ward during each of two 12-month phases of a crossover study (one phase when a PX-UV device is added and one when a sham device is added to standard terminal cleaning).

The long-term goal of this project is to establish the efficacy of terminal cleaning plus PX-UV in reducing rates of HAIs due to the following multi-drug resistant organisms (MDROs): C. difficile, vancomycin-resistant enterococci (VRE), Klebsiella pneumoniae and Escherichia coli producing extended-spectrum beta-lactamases (ESBLs), methicillin-resistant Staphylococcus aureus (MRSA) and Acinetobacter baumannii.

At the conclusion of the proposed project, novel data will be generated from this rigorously controlled study regarding the effectiveness of PX-UV in reducing HAIs in a representative, real-world healthcare setting.

To learn more about this Clinical study in progress – please click on the following link to be redirected to clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT03349268?cond=Clostridium+Difficile&draw=5&rank=240

 

 

Learn More About Clostridium difficile (C.diff., C.difficile) infection and Recurrent CDI Clinical Trials In Progress

 

 

 

The C Diff Foundation has implemented a global campaign to raise awareness of Clostridium difficile infection (C.difficile) clinical trials, clinical studies, clinical research and observational studies evaluating interventions for C. difficile prevention, treatments, and environmental safety.

In the USA: Nearly half a million Americans suffer from Clostridium difficile (C. diff.) infections in a single year according to a study released in 2015 by the Centers for Disease Control and Prevention (CDC). Approximately 29,000 patients died within 30 days of the initial diagnosis of C. difficile. Of those, about 15,000 deaths were estimated to be directly attributable to C. difficile infections making C. difficile a very important cause of infectious disease death in the United States.

“Clostridium difficile infections are not only the most common cause of healthcare-acquired infections in the United States but also very common in the community in younger patients who previously were thought to be less susceptible to C. difficile. The rate of recurrent C. difficile infections is increasing tremendously and this increase is higher than the rate of primary C. difficile infections,” stated Sahil Khanna, MD, Assistant Professor of Medicine Division of Gastroenterology and Hepatology, Director of the C. difficile Clinic, Fecal Microbiota Transplantation program and C. difficile related Clinical Trials, Mayo Clinic, Rochester, MN.

Dr. Khanna also added, “It is imperative and important for clinical trials to be done to advance the development of new treatments, new medications, and new ways to prevent and treat Clostridium difficile infections.”

Individuals volunteer to participate in clinical trials in hopes of improving their own health, to access treatments that might not be available otherwise, often because they are new and not yet widely available. They help others by contributing to advances in medicine. There can also be potential risks participating in clinical trials and clinical studies. All of the known risks associated with a particular trial and or study will be discussed during the informed consent process. It will be thoroughly explained in the informed consent document that a volunteer will receive from the research staff prior to participating in any study.

To learn more about clinical research (e.g., Clostridium difficile, C.difficile) visit the U.S. Food and Drug Administration http://www.fda.gov or telephone 1-800-835-4709, The National Institutes of Health (NIH) http://www.nih.gov and ClinicalTrials.gov.

“Clinical trials are vital to improving our knowledge about how best to prevent and treat C. difficile infections. Informing patients of clinical trials is important, and in recent years several clinical trials have led to significant improvements in the treatments available for patients with C. difficile infections,” stated Mark Wilcox, MD, FRCPath, Consultant Microbiologist, Head of Microbiology and Academic Lead of Pathology Leeds Teaching Hospitals, Professor of Medical Microbiology University of Leeds Institute of Biomedical and Clinical Sciences, Lead on Clostridium difficile for Public Health England, UK.

About the U.S. Food and Drug Administration (FDA):
The FDA is responsible for protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drug, and vaccines and other biological products and medical devices intended for human use are safe and effective. FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.

About the National Institutes of Health (NIH):
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency making important discoveries that improve health and save lives.

About ClinicalTrials.gov
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.