Environmental Contamination Clinical Trial
Official title:
Effect of MVX (Titanium Dioxide) on the Microbial Colonization of Surfaces in an Intensive Care Unit
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).
Introduction and background
Background The annual epidemiological report and annual report of the EARS-NET of the
European Centre for Disease Prevention and Control (ECDC) describes a continuing
deteriorating situation in European countries. Antimicrobial resistance is increasing in
Escherichia coli and Klebsiella pneumoniae isolates and surveillance data show high
percentages of ESBL-positive isolates. Of particular concern is the increased percentage of
Klebsiella pneumoniae and other bacterial groups resistant to carbapanems (last line
antibiotics). Furthermore, the percentage of methicillin-resistant Staphylococcus aureus is
still high and remains a public health priority On any given day 5.7% of the patients in
European hospitals has a healthcare-associated infection (HAI) with a prevalence of at least
one HAI of 19.5% for patients admitted to Intensive Care Units. HAIs are accountable for at
least 37000 attributable deaths with annual financial losses estimated at €7 billion
reflecting 16 million extra days of hospital stay. Each year 4 131 000 patients are affected
by approximately 4 544 100 episodes of HAIs.
The total number of HAIs in European long-term care facilities (LTCFs) is estimated at 4.2
million per year.
8% to 12% of patients in developed countries is confronted with an adverse event (AE) during
their hospital stay leading to (permanent) disability or even dead. As HAIs belong to one of
the most important AEs they have a considerable economic impact prolonging hospital length
of stay, increase readmission rates and necessitate additional ambulatory care or extra
societal costs. The total preventable direct medical costs of AEs in the Netherlands are
estimated as 1% of the national health care budget (94.2 billion 2013 - Statistics
Netherlands).
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. Surviving days, weeks or even months in the
environment. 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. 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.
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 patient. 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. 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. 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. 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.
To the best of our knowledge there is just one study who examined the efficacy of titanium
dioxide in reducing MRSA contamination in a hospital environment 19. In this cross-sectional
observational study two ICU isolation rooms were coated and four beds in a 'Intermediate
Care Area' (ICA). However, this study had some serious limitations. As 81% of all the
samples (N=698) were taken from untreated surfaces there was a high chance of sampling bias.
Especially as just 9% of all the samples were taken from the ICA, containing four of the six
coated beds/rooms, against 48% of the ICU and 42% of a general ward. Furthermore, as just
10.6% of the samples were positive (N=74) we can really doubt about the validity of this
study by the small sample size. Finally, countries with a low prevalence of MRSA (e.g. the
Netherlands) are more interested in the prevalence of Enterobacteriaecae or non-MRSA
(potential pathogenic microorganisms) and using a (semi)quantitative method.
This makes that 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).
;
Observational Model: Ecologic or Community, Time Perspective: Prospective