Environmental Contamination Clinical Trial
— TITANICOfficial title:
Effect of MVX (Titanium Dioxide) on the Microbial Colonization of Surfaces in an Intensive Care Unit
| Verified date | August 2016 |
| Source | Gelderse Vallei Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Netherlands: Independant Ethic Committee |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | May 2016 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All patients admitted to the Intensive Care Unit and allocated to one of the four rooms Exclusion Criteria: |
Observational Model: Ecologic or Community, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Gelderse Vallei Hospital | Ede | Gelderland |
| Lead Sponsor | Collaborator |
|---|---|
| drs. B. de Jong |
Netherlands,
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.
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.
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.
Crnich CJ, Safdar N, Maki DG. The role of the intensive care unit environment in the pathogenesis and prevention of ventilator-associated pneumonia. Respir Care. 2005 Jun;50(6):813-36; discussion 836-8. Review. — View Citation
Hoonhout LH, de Bruijne MC, Wagner C, Zegers M, Waaijman R, Spreeuwenberg P, Asscheman H, van der Wal G, van Tulder MW. Direct medical costs of adverse events in Dutch hospitals. BMC Health Serv Res. 2009 Feb 9;9:27. doi: 10.1186/1472-6963-9-27. — View Citation
Hota B. Contamination, disinfection, and cross-colonization: are hospital surfaces reservoirs for nosocomial infection? Clin Infect Dis. 2004 Oct 15;39(8):1182-9. Epub 2004 Sep 27. — View Citation
Joseph NM, Sistla S, Dutta TK, Badhe AS, Rasitha D, Parija SC. Role of intensive care unit environment and health-care workers in transmission of ventilator-associated pneumonia. J Infect Dev Ctries. 2010 Jun 3;4(5):282-91. — View Citation
Mahida N, Beal A, Trigg D, Vaughan N, Boswell T. Outbreak of invasive group A streptococcus infection: contaminated patient curtains and cross-infection on an ear, nose and throat ward. J Hosp Infect. 2014 Jul;87(3):141-4. doi: 10.1016/j.jhin.2014.04.007. Epub 2014 May 10. — View Citation
Moore G, Muzslay M, Wilson AP. The type, level, and distribution of microorganisms within the ward environment: a zonal analysis of an intensive care unit and a gastrointestinal surgical ward. Infect Control Hosp Epidemiol. 2013 May;34(5):500-6. doi: 10.1086/670219. — View Citation
Oberauner L, Zachow C, Lackner S, Högenauer C, Smolle KH, Berg G. The ignored diversity: complex bacterial communities in intensive care units revealed by 16S pyrosequencing. Sci Rep. 2013;3:1413. doi: 10.1038/srep01413. — View Citation
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Shiferaw T, Beyene G, Kassa T, Sewunet T. Bacterial contamination, bacterial profile and antimicrobial susceptibility pattern of isolates from stethoscopes at Jimma University Specialized Hospital. Ann Clin Microbiol Antimicrob. 2013 Dec 13;12:39. doi: 10.1186/1476-0711-12-39. — View Citation
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Wolf I, Bergervoet PW, Sebens FW, van den Oever HL, Savelkoul PH, van der Zwet WC. The sink as a correctable source of extended-spectrum ß-lactamase contamination for patients in the intensive care unit. J Hosp Infect. 2014 Jun;87(2):126-30. doi: 10.1016/j.jhin.2014.02.013. Epub 2014 Apr 18. — View Citation
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* Note: There are 20 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 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. | Up to 10 weeks | No |
| Secondary | 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. | Up to 10 weeks | No | |
| Secondary | 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. | Up to 10 weeks | No | |
| Secondary | 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. | Up to 10 weeks | No | |
| Secondary | Number of positive microbiological culture plates (plates with = 1 CFUs after 48 hrs of incubation) | Up to 10 weeks | No | |
| Secondary | Number of positive culture sites (plates of culture sites with = 1 CFUs after 48 hrs of incubation) | Up to 10 weeks | No |