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Can Environmental Cleanliness be Assessed by BCA (Bicinchoninic Acid) Method (BCA)

Primary Purpose

Nosocomial Infection, Infection Control, Multi-antibiotic Resistance

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
BCA method for assessing environmental cleanliness
Sponsored by
Cumhuriyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nosocomial Infection focused on measuring Intensive care unit, Infection Control, Microbiological Monitoring, High-touch surfaces, Fluorescent marker, Hospital environment, Cleanliness assessment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.-

Exclusion Criteria:

  • 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.

Sites / Locations

  • Cumhuriyet University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evaluation of environmental cleanliness

Arm Description

In this study, fluorescent marking, microbiological sampling and BCA methods will be compared in order to evaluate the effectiveness and usability of BCA method

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 19, 2019
Last Updated
April 21, 2020
Sponsor
Cumhuriyet University
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1. Study Identification

Unique Protocol Identification Number
NCT04212130
Brief Title
Can Environmental Cleanliness be Assessed by BCA (Bicinchoninic Acid) Method
Acronym
BCA
Official Title
The Effect of Fluorescent Marking and BCA Methods of Patient Unit Cleaning in Intensive Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
April 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infection, Infection Control, Multi-antibiotic Resistance
Keywords
Intensive care unit, Infection Control, Microbiological Monitoring, High-touch surfaces, Fluorescent marker, Hospital environment, Cleanliness assessment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation of environmental cleanliness
Arm Type
Experimental
Arm Description
In this study, fluorescent marking, microbiological sampling and BCA methods will be compared in order to evaluate the effectiveness and usability of BCA method
Intervention Type
Other
Intervention Name(s)
BCA method for assessing environmental cleanliness
Other Intervention Name(s)
Pro 1 Micro Hygiene Monitoring Systems
Intervention Description
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
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of cleaning
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To evaluate the effectiveness of BCA method
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.- Exclusion Criteria: 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.
Facility Information:
Facility Name
Cumhuriyet University
City
Sivas
Country
Turkey

12. IPD Sharing Statement

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Can Environmental Cleanliness be Assessed by BCA (Bicinchoninic Acid) Method

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