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

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).

Study Overview

• Status: Completed
• Conditions: Nosocomial Infection; Multi-antibiotic Resistance; Infection Control
• Intervention / Treatment: Other: BCA method for assessing environmental cleanliness

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sivas, Turkey
    • Cumhuriyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Evaluation of environmental cleanliness; In this study,; fluorescent marking,; microbiological sampling and; BCA methods will be compared in order to evaluate the effectiveness and usability of BCA method

Other: BCA method for assessing environmental cleanliness; 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; Other Names: Pro 1 Micro Hygiene Monitoring Systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Cumhuriyet University

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): April 21, 2020

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Intensive care unit; Infection Control; Hospital environment; Microbiological Monitoring; High-touch surfaces; Fluorescent marker; Cleanliness assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Cross Infection
• Other Study ID Numbers: Cumhuriyet University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No