Air, SurfacesNCT05083819
Microbiological Assessment of Air and Surfaces of Operation Rooms in Assuit University Hospitals
An observational study of Air, Surfaces, run by Assiut University.
Trial summary
1. To determine the bacteriological load on air and surfaces within the ORs. 2. To isolate and identify pathogenic strains of bacteria on equipments and contact surfaces. 3. To compare between adenosine triphosphate bioluminescence assay and the ordinary cultures in order to verify whether the methods of hygienization… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Air, Surfaces
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Dec 2021to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Because there is no patient in our study , the study will be carried out on these samples which classified into the following groups as follows: * Group 1: 100 samples before starting the surgery in the morning * Group 2: 100 samples between the surgeries **These samples will be taken by ordinary swabs, the adenosine triphosphate bioluminescence and the air sampler.
Who may be able to join
- The study will be carried out in the operation rooms.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
- To determine the bacteriological load on air and surfaces within the ORs.
- To isolate and identify pathogenic strains of bacteria on equipments and contact surfaces.
- To compare between adenosine triphosphate bioluminescence assay and the ordinary cultures in order to verify whether the methods of hygienization and disinfection implemented were in fact effective.
Read the detailed description
Healthcare-associated infections often have multiple etiologies, of which cleanliness of hospital surfaces can play a large role. This is perhaps most important in the operating room, where a sterile environment is paramount to decreasing the burden of hospital-acquired morbidity and surgical site infections. Contaminated hospital surfaces greatly contribute to the transmission of healthcare associated pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus spp (VRE), and Clostridium difficile Surgical site infections (SSIs) are infections that occur after surgery in the part of the body where the surgery took place and account for about 14-20% of all hospital-acquired (nosocomial) infections. Some are superficial, involving only the skin, while others are more serious and can involve tissues under the skin, organs, or implanted material. Factors causing SSIs are known to be multifarious. Superficial SSIs are most often associated with environmental factors, such as environmental contamination by fungi and bacteria, surface contamination, humidity, differential pressure and temperature of the OR, while factors that determine deep and organ/space SSIs are more often associated with patient characteristics (age, sex, transfusion, nasogastric feeding and nutrition, as measured by the level of albumin in the blood), type of intervention and preoperative stay .
SSIs continue to be a major problem in modern medicine, with both individual and economic consequences. They are the most frequent nosocomial infections in low- and middle-income countries, affecting up to one third of patients who have undergone a surgical procedure, while in high-income countries they are the second most frequent type .
Contaminated surfaces and fomites are considered an important reservoir of (multi-resistant) microorganisms in hospitals. Therefore, cleaning of the environment is important for reducing bacterial spread, controlling antimicrobial resistance and improving patient .
Air quality in ORs should be assessed during microbiological commissioning of new ORs and whenever required thereafter. OR ventilations are very much variable from country to country, within a country and even within a hospital as per requirement and availability. Ventilation systems are classified as conventional plenum ventilation (CV), laminar flow ventilation (LAF), wall mounted air conditioners and free-standing air conditioners.
Microbial monitoring of ORs (and also of other controlled environments, such as recovery rooms) is therefore essential to obtain representative estimates of the bioburden of the environment. It includes quantitation of the microbial content of room air, compressor air that enters the critical area, surfaces, equipment, sanitization containers, floors, walls and personnel garments and also the search for Legionella pneumophila in the water systems. Information gathered from the data compiled and analysed can then be useful in the investigation of the source of the contamination and the subsequent adoption of preventive measures.
The assessment of the cleanliness of surfaces in hospitals is mostly conducted by visual inspection. This method is not sensitive and subjective and therefore unreliable. Recently, a more objective technique was introduced to measure biological contamination. This technique is based on the measurement of adenosine triphosphate (ATP), a molecule that is present in all organic cells.
Traditional microbiological techniques are the most commonly used methods to evaluate hygienic quality, but they require specific skills, long execution and analysis times and are therefore unsuitable for routine monitoring. In the last decade alternative methods for assessing environmental cleanliness have been proposed, including the adenosine triphosphate (ATP) bioluminescence assay,based on the measurement of levels of ATP present on an environmental surface. Bioluminescence test exploits the chemiluminescence properties of luciferin-luciferase reagent, which reacts with any ATP residue present on a substrate, emitting light and measuring the presence of organic matter.
The air Sampler is a high-performance instrument that is based on the principle of the Andersen air sampler, which aspirates air through a perforated plate. The resulting airflow is directed onto a 90 mm Petri dish containing agar. For each air sample collection, the air Sampler equipment is placed on a firm support at about 1 m above the ground, the perforated lid is opened by rotating to the right and cleaned with isopropanol. Next, a closed 90 mm Petri dish filled with agar isplaced on top of the dish support, the lid was taken off the Petri dish, the air Sampler perforated lid is closed, the angle of the sampling head is adjusted and the equipment is programmed to aspire 500 L of air (flow rate of 100L/min). After the collection cycle, the sampling head is opened and the Petri dish is closed with the Petri dish cover and placed in the cooler to later be transported to the laboratory.
Microbial monitoring of ORs (and also of other controlled environments, such as recovery rooms) is therefore essential to obtain representative estimates of the bioburden of the environment. It includes quantitation of the microbial content of room air, compressor air that enters the critical area, surfaces, equipment, sanitization containers, floors, walls and personnel garments and also the search for Legionella pneumophila in the water systems. Information gathered from the data compiled and analysed can then be useful in the investigation of the source of the contamination and the subsequent adoption of preventive measures.
Since then research has provided evidence of the importance of establishing environmental monitoring programs to control and maintain an aseptic hospital environment, especially in operating rooms.
- Conditions
- Air, Surfaces
What is being measured
The primary outcome is the main question the study is designed to answer.
1.To determine the bacteriological load on air and surfaces within the ORs.
To isolate and identify pathogenic strains of bacteria on equipments and contact surfaces.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Air, SurfacesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Hussien Mahran Shehata, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083819
- Sponsor's protocol ID
- Microbiological assessment
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
ALFONSO-SANCHEZ, J. L., MARTINEZ, I. M., MARTíN-MORENO, J. M., GONZáLEZ, R. S. & BOTíA, F. 2017. Analyzing the risk factors influencing surgical site infections: the site of environmental factors. Canadian Journal of Surgery, 60, 155. ALMEIDA, B. I. M. 2017. Microbiological assessment of air and surfaces of surgery rooms from a lisbon hospital. DANCER, S. J. 2008. Importance of the environment in meticillin-resistant Staphylococcus aureus acquisition: the case for hospital cleaning. The Lancet infectious diseases, 8, 101-113. MORA, M., MAHNERT, A., KOSKINEN, K., PAUSAN, M. R., OBERAUNER-WAPPIS, L., KRAUSE, R., PERRAS, A. K., GORKIEWICZ, G., BERG, G. & MOISSL-EICHINGER, C. 2016. Microorganisms in confined habitats: microbial monitoring and control of intensive care units, operating rooms, cleanrooms and the International Space Station. Frontiers in microbiology, 7, 1573. ORGANIZATION, W. H. 2016. Global guidelines for the prevention of surgical site infection, World Health Organization. RICHARD, R. D. & BOWEN, T. R. 2017. What orthopaedic operating room surfaces are contaminated with bioburden? A study using the ATP bioluminescence assay. Clinical Orthopaedics and Related Research®, 475, 1819-1824. SANNA, T., DALLOLIO, L., RAGGI, A., MAZZETTI, M., LORUSSO, G., ZANNI, A., FARRUGGIA, P. & LEONI, E. 2018. ATP bioluminescence assay for evaluating cleaning practices in operating theatres: applicability and limitations. BMC infectious diseases, 18, 1-7. TSHOKEY, T., SOMARATNE, P. & AGAMPODI, S. B. 2016. Comparison of two air sampling methods to monitor operating room air quality and assessment of air quality in two operating rooms with different ventilation systems in the national hospital of Sri Lanka. VAN ARKEL, A., WILLEMSEN, I., KILSDONK-BODE, L., VLAMINGS-WAGENAARS, S., VAN OUDHEUSDEN, A., WAEGEMAEKER, P. D., LEROUX-ROELS, I., VERELST, M., MAAS, E. & VAN OOSTEN, A. 2020. ATP measurement as an objective method to measure environmental contamination in 9 hospitals in the Dutch/Belgian border area. Antimicrobial Resistance & Infection Control, 9, 1-8. VANDINI, A., TEMMERMAN, R., FRABETTI, A., CASELLI, E., ANTONIOLI, P., BALBONI, P. G., PLATANO, D., BRANCHINI, A. & MAZZACANE, S. 2014. Hard surface biocontrol in hospitals using microbial-based cleaning products. PLoS One, 9, e108598. WEBER, D. J., ANDERSON, D. & RUTALA, W. A. 2013. The role of the surface environment in healthcare-associated infections. Current opinion in infectious diseases, 26, 338-344.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Assessment of Air and Surfaces of Operation Rooms in Assuit University Hospitals
- ClinicalTrials.gov ID
- NCT05083819
- Acronym / sponsor ID
- Microbiological assessment
- Conditions
- Air, Surfaces
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine the bacteriological load on air and surfaces within the ORs.
- To isolate and identify pathogenic strains of bacteria on equipments and contact surfaces.
- To compare between adenosine triphosphate bioluminescence assay and the ordinary cultures in order to verify whether the methods of hygienization and disinfection implemented were in fact effective.
Detailed description
Healthcare-associated infections often have multiple etiologies, of which cleanliness of hospital surfaces can play a large role. This is perhaps most important in the operating room, where a sterile environment is paramount to decreasing the burden of hospital-acquired morbidity and surgical site infections. Contaminated hospital surfaces greatly contribute to the transmission of healthcare associated pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus spp (VRE), and Clostridium difficile Surgical site infections (SSIs) are infections that occur after surgery in the part of the body where the surgery took place and account for about 14-20% of all hospital-acquired (nosocomial) infections. Some are superficial, involving only the skin, while others are more serious and can involve tissues under the skin, organs, or implanted material. Factors causing SSIs are known to be multifarious. Superficial SSIs are most often associated with environmental factors, such as environmental contamination by fungi and bacteria, surface contamination, humidity, differential pressure and temperature of the OR, while factors that determine deep and organ/space SSIs are more often associated with patient characteristics (age, sex, transfusion, nasogastric feeding and nutrition, as measured by the level of albumin in the blood), type of intervention and preoperative stay .
SSIs continue to be a major problem in modern medicine, with both individual and economic consequences. They are the most frequent nosocomial infections in low- and middle-income countries, affecting up to one third of patients who have undergone a surgical procedure, while in high-income countries they are the second most frequent type .
Contaminated surfaces and fomites are considered an important reservoir of (multi-resistant) microorganisms in hospitals. Therefore, cleaning of the environment is important for reducing bacterial spread, controlling antimicrobial resistance and improving patient .
Air quality in ORs should be assessed during microbiological commissioning of new ORs and whenever required thereafter. OR ventilations are very much variable from country to country, within a country and even within a hospital as per requirement and availability. Ventilation systems are classified as conventional plenum ventilation (CV), laminar flow ventilation (LAF), wall mounted air conditioners and free-standing air conditioners.
Microbial monitoring of ORs (and also of other controlled environments, such as recovery rooms) is therefore essential to obtain representative estimates of the bioburden of the environment. It includes quantitation of the microbial content of room air, compressor air that enters the critical area, surfaces, equipment, sanitization containers, floors, walls and personnel garments and also the search for Legionella pneumophila in the water systems. Information gathered from the data compiled and analysed can then be useful in the investigation of the source of the contamination and the subsequent adoption of preventive measures.
The assessment of the cleanliness of surfaces in hospitals is mostly conducted by visual inspection. This method is not sensitive and subjective and therefore unreliable. Recently, a more objective technique was introduced to measure biological contamination. This technique is based on the measurement of adenosine triphosphate (ATP), a molecule that is present in all organic cells.
Traditional microbiological techniques are the most commonly used methods to evaluate hygienic quality, but they require specific skills, long execution and analysis times and are therefore unsuitable for routine monitoring. In the last decade alternative methods for assessing environmental cleanliness have been proposed, including the adenosine triphosphate (ATP) bioluminescence assay,based on the measurement of levels of ATP present on an environmental surface. Bioluminescence test exploits the chemiluminescence properties of luciferin-luciferase reagent, which reacts with any ATP residue present on a substrate, emitting light and measuring the presence of organic matter.
The air Sampler is a high-performance instrument that is based on the principle of the Andersen air sampler, which aspirates air through a perforated plate. The resulting airflow is directed onto a 90 mm Petri dish containing agar. For each air sample collection, the air Sampler equipment is placed on a firm support at about 1 m above the ground, the perforated lid is opened by rotating to the right and cleaned with isopropanol. Next, a closed 90 mm Petri dish filled with agar isplaced on top of the dish support, the lid was taken off the Petri dish, the air Sampler perforated lid is closed, the angle of the sampling head is adjusted and the equipment is programmed to aspire 500 L of air (flow rate of 100L/min). After the collection cycle, the sampling head is opened and the Petri dish is closed with the Petri dish cover and placed in the cooler to later be transported to the laboratory.
Microbial monitoring of ORs (and also of other controlled environments, such as recovery rooms) is therefore essential to obtain representative estimates of the bioburden of the environment. It includes quantitation of the microbial content of room air, compressor air that enters the critical area, surfaces, equipment, sanitization containers, floors, walls and personnel garments and also the search for Legionella pneumophila in the water systems. Information gathered from the data compiled and analysed can then be useful in the investigation of the source of the contamination and the subsequent adoption of preventive measures.
Since then research has provided evidence of the importance of establishing environmental monitoring programs to control and maintain an aseptic hospital environment, especially in operating rooms.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Because there is no patient in our study , the study will be carried out on these samples which classified into the following groups as follows: * Group 1: 100 samples before starting the surgery in the morning * Group 2: 100 samples between the surgeries **These samples will be taken by ordinary swabs, the adenosine triphosphate bioluminescence and the air sampler.
Key inclusion criteria (1 listed)
- The study will be carried out in the operation rooms.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1.To determine the bacteriological load on air and surfaces within the ORs.
Time frame: Baseline
To isolate and identify pathogenic strains of bacteria on equipments and contact surfaces.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- BackgroundALFONSO-SANCHEZ, J. L., MARTINEZ, I. M., MARTíN-MORENO, J. M., GONZáLEZ, R. S. & BOTíA, F. 2017. Analyzing the risk factors influencing surgical site infections: the site of environmental factors. Canadian Journal of Surgery, 60, 155. ALMEIDA, B. I. M. 2017. Microbiological assessment of air and surfaces of surgery rooms from a lisbon hospital. DANCER, S. J. 2008. Importance of the environment in meticillin-resistant Staphylococcus aureus acquisition: the case for hospital cleaning. The Lancet infectious diseases, 8, 101-113. MORA, M., MAHNERT, A., KOSKINEN, K., PAUSAN, M. R., OBERAUNER-WAPPIS, L., KRAUSE, R., PERRAS, A. K., GORKIEWICZ, G., BERG, G. & MOISSL-EICHINGER, C. 2016. Microorganisms in confined habitats: microbial monitoring and control of intensive care units, operating rooms, cleanrooms and the International Space Station. Frontiers in microbiology, 7, 1573. ORGANIZATION, W. H. 2016. Global guidelines for the prevention of surgical site infection, World Health Organization. RICHARD, R. D. & BOWEN, T. R. 2017. What orthopaedic operating room surfaces are contaminated with bioburden? A study using the ATP bioluminescence assay. Clinical Orthopaedics and Related Research®, 475, 1819-1824. SANNA, T., DALLOLIO, L., RAGGI, A., MAZZETTI, M., LORUSSO, G., ZANNI, A., FARRUGGIA, P. & LEONI, E. 2018. ATP bioluminescence assay for evaluating cleaning practices in operating theatres: applicability and limitations. BMC infectious diseases, 18, 1-7. TSHOKEY, T., SOMARATNE, P. & AGAMPODI, S. B. 2016. Comparison of two air sampling methods to monitor operating room air quality and assessment of air quality in two operating rooms with different ventilation systems in the national hospital of Sri Lanka. VAN ARKEL, A., WILLEMSEN, I., KILSDONK-BODE, L., VLAMINGS-WAGENAARS, S., VAN OUDHEUSDEN, A., WAEGEMAEKER, P. D., LEROUX-ROELS, I., VERELST, M., MAAS, E. & VAN OOSTEN, A. 2020. ATP measurement as an objective method to measure environmental contamination in 9 hospitals in the Dutch/Belgian border area. Antimicrobial Resistance & Infection Control, 9, 1-8. VANDINI, A., TEMMERMAN, R., FRABETTI, A., CASELLI, E., ANTONIOLI, P., BALBONI, P. G., PLATANO, D., BRANCHINI, A. & MAZZACANE, S. 2014. Hard surface biocontrol in hospitals using microbial-based cleaning products. PLoS One, 9, e108598. WEBER, D. J., ANDERSON, D. & RUTALA, W. A. 2013. The role of the surface environment in healthcare-associated infections. Current opinion in infectious diseases, 26, 338-344.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Air, Surfaces, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Hussien Mahran, MD (01009003285, e.shehata90@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.To determine the bacteriological load on air and surfaces within the ORs. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05083819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.