NCT04212130

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 9, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

7 days

First QC Date

December 19, 2019

Last Update Submit

April 21, 2020

Conditions

Keywords

Intensive care unitInfection ControlMicrobiological MonitoringHigh-touch surfacesFluorescent markerHospital environmentCleanliness assessment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To evaluate the effectiveness of BCA method

    1 year

Study Arms (1)

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

Other: BCA method for assessing environmental cleanliness

Interventions

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

Also known as: Pro 1 Micro Hygiene Monitoring Systems
Evaluation of environmental cleanliness

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.-

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cumhuriyet University

Sivas, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead researcher

Study Record Dates

First Submitted

December 19, 2019

First Posted

December 26, 2019

Study Start

March 9, 2020

Primary Completion

March 16, 2020

Study Completion

April 21, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Locations