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Effect of MVX (Titanium Dioxide) on the Microbial Colonization of Surfaces in an Intensive Care Unit (TITANIC)

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ClinicalTrials.gov Identifier: NCT02348346
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
drs. B. de Jong, Gelderse Vallei Hospital

Brief Summary:

Environmental cleanliness As antimicrobial resistance is a major and overall deteriorating public health problem international cooperation is necessary. Continued progress is needed to implement and improve programmes for the prevention and control of antimicrobial resistance and HAIs.

Environmental cleanliness might be one of the most important initiatives to reduce HAIs. Hospital surfaces are heavily contaminated with bacteria with the highest numbers on surfaces closest to the patients. Bed rails, nurse call buttons, curtains, towel dispensers, door handles, sinks, floors, clinical information stations, medical devices, stethoscopes, staff toilets etc. Actually, general hospital wards and Intensive Care Units are loaded with an abundance of potential pathogens 8,9,10. Surviving days, weeks or even months in the environment 11. Colonizing patients with bacteria from the hospital environment and getting HAIs or even die.

As most ventilator-associated pneumonias (VAPs) are the result of nosocomial microorganisms the environment plays an important role in the acquisition of pathogenic bacteria by contaminating health care workers hands and equipment 12,13. Furthermore, ICUs and wards struggle with colonized patients with ESBL-bacteria from sinks eventually leading to dead or outbreaks of group A streptococcus infections from contaminated curtains 14,15.

As key healthcare-associated pathogens have the capacity to persist for weeks to months on hospital surfaces indirect transmission is a serious threat, especially as antimicrobial resistance increases. Hospitalization in a room in which the previous patient had been colonized or infected with nosocomial pathogens (e.g. MRSA, VRE, multidrug-resistant Acinetobacter, Pseudomonas or C. difficile) has been shown to be a risk factor for colonization of infection with the same pathogen for the next patient16. Furthermore, the most important risk factor for hand and glove contamination of healthcare workers with multidrug-resistant bacteria has been demonstrated to be positive environmental cultures 17. To decrease the frequency and level of contamination of environmental surfaces the Centre for Disease Control and Prevention recommends routine disinfection of medical equipment and environmental surfaces to prevent the spread of potential pathogens through the hospital ward or ICU 18. Improved room cleaning has shown to decrease the risk for MRSA, VRE and C. difficile acquisition. Unfortunately, environmental cleaning is frequently inadequate. Less than 50% of hospital room surfaces are adequately cleaned and disinfected even by environmental services personnel. Environmental services personnel have low wages, are under time pressure to clean rooms quickly with high turn-over rates of patients. Novel materials and cleaning technologies have been developed as ultraviolet germicidal irradiation (UVGI) or hydrogen peroxide vapor (HPV). However, both technologies are expensive and can just be used for terminal cleaning and not during routine daily care 16. Self-disinfecting surfaces may overcome these problems. Once applied antimicrobial surfaces will continuously reduce the bioburden of nosocomial pathogens preventing transmission and decrease HAIs.

MVX One of these self-disinfecting products is MVX. MVX contains titanium dioxide which by the use of nanotechnology is now available for use in the health sector. Working as a photocatalyticum it generates, in the presence of light, hydroxy radicals and oxygen radicals for at least five years after coating hospital surfaces (durability test TUV Rheinland). Laboratory tests show that MVX is effective in killing bacteria, viruses and fungi (see attachment 1 for summary test results).

The positive results reported on the effects of MVX from laboratory evaluations still have to be confirmed in the clinical setting. After getting the CE-marking Gelderse Vallei Hospital in Ede, the Netherlands, will be the first hospital in Europe to study the efficacy of MVX in the Intensive Care Unit (ICU).


Condition or disease Intervention/treatment
Environmental Contamination Other: MVX (titanium dioxide)

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Effect of MVX (Titanium Dioxide) on the Microbial Colonization of Surfaces in an Intensive Care Unit
Study Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: MVX (titanium dioxide)
    The investigators have designed a prospective pre-post evaluation time-based pilot study addressing the microbial colonization of surfaces in four rooms of the ICU before and after coating with titanium dioxide (MVX). During a pre-intervention period cultures will be taken every 7 days from 10 prespecified and marked sites per room for a total duration of 4 weeks (sink, wall, floor, bed rail, door handle, ceiling, keyboard patient room, nurse call button, bedside table and monitor arm). After coating of the rooms with MVX another 4 weeks observation period will be used to gather samples in the post-intervention period.


Primary Outcome Measures :
  1. Reduction in colony forming units cultured from T, S and E plates and culture sites taken in four week period after coating the rooms compared to amount of CFUs cultured from cultures and from culture sites taken in period before application MVX. [ Time Frame: Up to 10 weeks ]
    Reduction in the total amount of all colony forming units (CFUs) cultured from all cultures (T, S and E plates) and from all culture sites taken in the four week period after coating of the rooms compared to the total amount of CFUs cultured from all cultures and from all culture sites taken in the period before application of MVX.


Secondary Outcome Measures :
  1. Reduction in colony forming units cultured from T plates and from culture sites taken in four week period after coating the rooms compared to amount of CFUs cultured from T plates and from culture sites taken in the period before application of MVX. [ Time Frame: Up to 10 weeks ]
  2. Reduction in colony forming units cultured from S plates and from culture sites taken in four week period after coating the rooms compared to CFUs cultured from all S plates and from all culture sites taken in the period before application of MVX. [ Time Frame: Up to 10 weeks ]
  3. Reduction in colony forming units cultured from E plates and from culture sites taken in four week period after coating the rooms compared to the CFUs cultured from all E plates and from all culture sites taken in the period before application of MVX. [ Time Frame: Up to 10 weeks ]
  4. Number of positive microbiological culture plates (plates with ≥ 1 CFUs after 48 hrs of incubation) [ Time Frame: Up to 10 weeks ]
  5. Number of positive culture sites (plates of culture sites with ≥ 1 CFUs after 48 hrs of incubation) [ Time Frame: Up to 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the Intensive Care Unit
Criteria

Inclusion Criteria:

  • All patients admitted to the Intensive Care Unit and allocated to one of the four rooms

Exclusion Criteria:

  • None

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): NCT02348346


Locations
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Netherlands
Gelderse Vallei Hospital
Ede, Gelderland, Netherlands, 6716 RP
Sponsors and Collaborators
drs. B. de Jong
Investigators
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Principal Investigator: Arthur van Zanten, MD, PhD Gelderse Vallei Hospital

Publications of Results:
1. European Centre for Disease Prevention and Control. Annual Epidemiological Report 2013. Reporting on 2011 surveillance data and 2012 epidemic intelligence data. Stockholm: ECDC; 2013.

Other Publications:
2. European Centre for Disease Prevention and Control. Antimicrobial resistance surveillance in Europe 2012. Annual Report of the European Antimicrobial Resistance Surveillance Network (EARS-Net). Stockholm: ECDC; 2013.
3. www.who.int/gpsc/country_work/gpsc_ccisc_fact_sheet_en.pdf
4. European Centre for Disease Prevention and Control. Point prevalence survey of healthcare-associated infections and antimicrobial use in European long-term care facilities. April-May 2013. Stockholm: ECDC;2014.
16. Steinberg et al. The role of the hospital environment in the prevention of healthcare-associated infections by contact transmission. HERD 2013;7(1):46-73.
18. www.cdc.gov/hicpac/pdf/guidelines/disinfection_nov_2008.pdf
19. Leng et al. Efficacy of titanium dioxide compounds in preventing environmental contamination by meticillin resistant Staphylococcus aureus (MRSA). Int J Infect Control 2013, v9:i3.

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Responsible Party: drs. B. de Jong, MD, Gelderse Vallei Hospital
ClinicalTrials.gov Identifier: NCT02348346    
Other Study ID Numbers: MVX 1.0
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
Keywords provided by drs. B. de Jong, Gelderse Vallei Hospital:
self-disinfecting surfaces
titanium dioxide
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Titanium dioxide
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents
Photosensitizing Agents