Nosocomial InfectionBCANCT04212130
Can Environmental Cleanliness be Assessed by BCA (Bicinchoninic Acid) Method
A study testing BCA method for assessing environmental cleanliness in people with Nosocomial Infection and Infection Control, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Effective cleaning of surfaces in the hospital environment is an absolute necessity to reduce pathogen transmission. Multi Drug Resistant Organisms (MDRO) in ICU are among the leading causes of hospital-acquired infections. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nosocomial Infection, Infection Control, Multi-antibiotic Resistance
- What is being tested?
- BCA method for assessing environmental cleanliness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Mar 2020to 21 Apr 2020
- Phase
- Interventional
- 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
Who may be able to join
- A patient infected with resistant microorganism in the unit is in the same unit for at least 72 hours
- The first BCA measurement when the unit is discharged gives a result indicating the unit is dirty.-
Who cannot join
- The patient who has been infected with the resistant microorganism in the unit has been hospitalized for less than 72 hours
- The first BCA measurement when the unit is empty does not give a result indicating that the unit is dirty.
- Impaired blindness for any reason included in the study
- In case the patient is included in the study but new patient admission to the unit before the cleaning stages are completed
- In the event that other employees who are included in the work but do not complete the cleaning stages enter and leave the unit, the work will be terminated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fluorescent Marking and BCA Methods of Patient Unit Cleaning in Intensive Care
Effective cleaning of surfaces in the hospital environment is an absolute necessity to reduce pathogen transmission. Multi Drug Resistant Organisms (MDRO) in ICU are among the leading causes of hospital-acquired infections. Today, the growing prevalence of MDRO has made it more important than ever to clean contaminated surfaces with appropriate aseptic cleaning procedures, to protect patients and personnel. Despite the disinfection and sterilization methods, microorganisms that reach a sufficient concentration in the hospital environment survive for long periods and can cause serious transmission via contaminated hands of healthcare workers. In this context, surface cleaning and disinfection procedures in the hospital environment reduce cross-contamination of the health care units and disease-causing pathogens. Recently, environmental cleaning and disinfection have become important as well as the evaluation of cleanliness.
The aim of this study is to evaluate the effectiveness and usability of BCA method, which is a new approach in evaluating the effectiveness of environmental cleanliness in intensive care units. fluoroscan gel marking, microbiological sampling and BCA assay methods will be compared to evaluate the effectiveness and usability of the BCA method. (PRO1 Micro Hygiene Monitoring System that System consisting of protein pen and device that analyzes with BCA method).
Read the detailed description
Patients admitted to the ICU are at great risk of developing nosocomial infections, partly because of their serious illness and partly because of exposure to life-saving invasive procedures. In ICU, implementation of invasive procedures, with the purpose of diagnosis and treatment, such as urinary catheter, central-peripheral catheter, intubation, and being subject to intensive antibiotic use increase the likelihood of infection. Environmental cleanliness is important for preventing infections.
Effective cleaning of surfaces in the hospital environment is an absolute necessity to reduce pathogen transmission. Multi Drug Resistant Organisms (MDRO) in ICU are among the leading causes of hospital-acquired infections. Today, the growing prevalence of MDRO has made it more important than ever to clean contaminated surfaces with appropriate aseptic cleaning procedures, to protect patients and personnel. Despite the disinfection and sterilization methods, microorganisms that reach a sufficient concentration in the hospital environment survive for long periods and can cause serious transmission via contaminated hands of healthcare workers. In this context, surface cleaning and disinfection procedures in the hospital environment reduce cross-contamination of the health care units and disease-causing pathogens. Recently, environmental cleaning and disinfection have become important as well as the evaluation of cleanliness.
Cleaning of frequently contacted environmental surfaces, monitoring and verifying the cleaning results are important for patient safety. The effectiveness of environmental cleaning can be assay by different methods. Visual evaluation, ATP (AdenosineTriphosphate) measurement, protein tests and fluoroscan marking methods are some of them.
Evaluation of the patient unit cleanup in the ICU, that is carried out after the discharge of patients with infection or colonization that would require strict contact isolation, by Fluoroscan Marking, BCA and Microbiological Sampling methods, is planned with the aim of collecting data in order to prove the efficiency and clinical employability of the new cleaning assessment method, PRO1 Micro Hygiene Monitoring System (System consisting of protein pen and device that analyzes with BCA method).
- Being tested
- BCA method for assessing environmental cleanliness
- Keywords
- Intensive care unit, Infection Control, Microbiological Monitoring, High-touch surfaces, Fluorescent marker, Hospital environment, Cleanliness assessment
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCA method for assessing environmental cleanlinessOther
Also called Pro 1 Micro Hygiene Monitoring Systems
Evaluating the effectiveness and usability of BCA method which is a new approach in evaluating the effectiveness of environmental cleanliness in intensive care units.
In this study, fluorecan labeling, microbiological sampling and BCA methods will be compared in order to evaluate the effectiveness and usability of BCA method
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of environmental cleanliness | Experimental | In this study,
1. fluorescent marking,
2. microbiological sampling and
3. BCA methods will be compared in order to evaluate the effectiveness and usability of BCA method Receives: Other: BCA method for assessing environmental cleanliness |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of cleaning
The absence of gel residue on the surfaces indicates that the wiping process is effective. Microbiological samples will determine the presence and amount of bacteria (colony) in the environment. It is aimed that bacteria cannot be produced in the samples taken from the environment after cleaning. The BCA protein samples will be analyzed by the researcher using the PRO 1 Micro hygiene monitoring device. PRO 1 Micro hygiene monitoring device will detect the presence of biological material on the surfaces. The presence and amount of bacteria on the surface will be determined with BCA protein. The presence and amount of bacteria can be detected by BCA protein swab, but not by bacterial species. The device is capable of detecting the biological load between 1 - 10 micrograms. Areas with values above 5 micrograms will be considered as dirty, areas with values below 5 micrograms will be considered as clean
Measured: 1 year
Secondary outcomes (1)
To evaluate the effectiveness of BCA method
If cleaning is not considered to be effective, cleaning will be repeated. If the results of samples taken with BCA protein pen after effective cleaning are below 5 microns, it is concluded that the area, is clean. If the BCA method (micrograms) shows clean or similar results in microbiological samples (colony), it will be concluded that the BCA method can be used to evaluate surface cleanliness.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start9 Mar 2020
- Primary completion16 Mar 2020
- Study completion21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nosocomial InfectionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zuhal Gülsoy, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212130
- Sponsor's protocol ID
- Cumhuriyet University
- Acronym
- BCA
- Status last verified
- Apr 2020
- First submitted
- 19 Dec 2019
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluorescent Marking and BCA Methods of Patient Unit Cleaning in Intensive Care
- ClinicalTrials.gov ID
- NCT04212130
- Acronym / sponsor ID
- BCA / Cumhuriyet University
- Keywords
- Intensive care unit, Infection Control, Microbiological Monitoring, High-touch surfaces, Fluorescent marker, Hospital environment, Cleanliness assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 26 Dec 2019 (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.
Effective cleaning of surfaces in the hospital environment is an absolute necessity to reduce pathogen transmission. Multi Drug Resistant Organisms (MDRO) in ICU are among the leading causes of hospital-acquired infections. Today, the growing prevalence of MDRO has made it more important than ever to clean contaminated surfaces with appropriate aseptic cleaning procedures, to protect patients and personnel. Despite the disinfection and sterilization methods, microorganisms that reach a sufficient concentration in the hospital environment survive for long periods and can cause serious transmission via contaminated hands of healthcare workers. In this context, surface cleaning and disinfection procedures in the hospital environment reduce cross-contamination of the health care units and disease-causing pathogens. Recently, environmental cleaning and disinfection have become important as well as the evaluation of cleanliness.
The aim of this study is to evaluate the effectiveness and usability of BCA method, which is a new approach in evaluating the effectiveness of environmental cleanliness in intensive care units. fluoroscan gel marking, microbiological sampling and BCA assay methods will be compared to evaluate the effectiveness and usability of the BCA method. (PRO1 Micro Hygiene Monitoring System that System consisting of protein pen and device that analyzes with BCA method).
Detailed description
Patients admitted to the ICU are at great risk of developing nosocomial infections, partly because of their serious illness and partly because of exposure to life-saving invasive procedures. In ICU, implementation of invasive procedures, with the purpose of diagnosis and treatment, such as urinary catheter, central-peripheral catheter, intubation, and being subject to intensive antibiotic use increase the likelihood of infection. Environmental cleanliness is important for preventing infections.
Effective cleaning of surfaces in the hospital environment is an absolute necessity to reduce pathogen transmission. Multi Drug Resistant Organisms (MDRO) in ICU are among the leading causes of hospital-acquired infections. Today, the growing prevalence of MDRO has made it more important than ever to clean contaminated surfaces with appropriate aseptic cleaning procedures, to protect patients and personnel. Despite the disinfection and sterilization methods, microorganisms that reach a sufficient concentration in the hospital environment survive for long periods and can cause serious transmission via contaminated hands of healthcare workers. In this context, surface cleaning and disinfection procedures in the hospital environment reduce cross-contamination of the health care units and disease-causing pathogens. Recently, environmental cleaning and disinfection have become important as well as the evaluation of cleanliness.
Cleaning of frequently contacted environmental surfaces, monitoring and verifying the cleaning results are important for patient safety. The effectiveness of environmental cleaning can be assay by different methods. Visual evaluation, ATP (AdenosineTriphosphate) measurement, protein tests and fluoroscan marking methods are some of them.
Evaluation of the patient unit cleanup in the ICU, that is carried out after the discharge of patients with infection or colonization that would require strict contact isolation, by Fluoroscan Marking, BCA and Microbiological Sampling methods, is planned with the aim of collecting data in order to prove the efficiency and clinical employability of the new cleaning assessment method, PRO1 Micro Hygiene Monitoring System (System consisting of protein pen and device that analyzes with BCA method).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of environmental cleanliness | Experimental | Other: BCA method for assessing environmental cleanlinessIn this study, 1. fluorescent marking, 2. microbiological sampling and 3. BCA methods will be compared in order to evaluate the effectiveness and usability of BCA method |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- A patient infected with resistant microorganism in the unit is in the same unit for at least 72 hours
- The first BCA measurement when the unit is discharged gives a result indicating the unit is dirty.-
Key exclusion criteria (5 listed)
- The patient who has been infected with the resistant microorganism in the unit has been hospitalized for less than 72 hours
- The first BCA measurement when the unit is empty does not give a result indicating that the unit is dirty.
- Impaired blindness for any reason included in the study
- In case the patient is included in the study but new patient admission to the unit before the cleaning stages are completed
- In the event that other employees who are included in the work but do not complete the cleaning stages enter and leave the unit, the work will be terminated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCA method for assessing environmental cleanlinessAlso: Pro 1 Micro Hygiene Monitoring SystemsEvaluating the effectiveness and usability of BCA method which is a new approach in evaluating the effectiveness of environmental cleanliness in intensive care units. In this study, fluorecan labeling, microbiological sampling and BCA methods will be compared in order to evaluate the effectiveness and usability of BCA method | Other | Evaluation of environmental cleanliness |
Primary outcome
To evaluate the effectiveness of cleaning
Time frame: 1 year
The absence of gel residue on the surfaces indicates that the wiping process is effective. Microbiological samples will determine the presence and amount of bacteria (colony) in the environment. It is aimed that bacteria cannot be produced in the samples taken from the environment after cleaning. The BCA protein samples will be analyzed by the researcher using the PRO 1 Micro hygiene monitoring device. PRO 1 Micro hygiene monitoring device will detect the presence of biological material on the surfaces. The presence and amount of bacteria on the surface will be determined with BCA protein. The presence and amount of bacteria can be detected by BCA protein swab, but not by bacterial species. The device is capable of detecting the biological load between 1 - 10 micrograms. Areas with values above 5 micrograms will be considered as dirty, areas with values below 5 micrograms will be considered as clean
1 secondary outcome
To evaluate the effectiveness of BCA method
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCA method for assessing environmental cleanliness in people with Nosocomial Infection and Infection Control, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of cleaning (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2020.