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Organosilane for Surface Cleaning in Intensive Care Units (ORG-CLEAN)

Primary Purpose

Infection, Hospital

Status
Not yet recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Surface disinfection with Organosilane
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection, Hospital focused on measuring Infection Control, Infections, Intensive Care Units, Pneumonia, Ventilator Associated, Catheter-Related Infections, Urinary Tract Infections, Organosilanes, Costs and Cost Analyses

Eligibility Criteria

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

Inclusion Criteria: All patients aged 18 years and older who will be admitted to the participating ICUs Exclusion Criteria: Patients under 18 years ICUs that may use any organosilane formulation for surface disinfection

Sites / Locations

  • Santa Casa de Misericórdia
  • Hospital Jean Bittar
  • Hospital de Base do Distrito Federal
  • Hospital Universitário de Brasília
  • Hospital Otoclínica
  • Hospital do Tricentenário
  • Hospital Escola Universidade Federal de Pelotas
  • Hospital Ernesto Dornelles
  • Hospital Ana Nery
  • Hospital Santa Cruz
  • Hospital Presidente Vargas
  • A.C. Camargo Cancer Center
  • Hospital do Coração

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surface disinfection with organosilane

Usual surface disinfection

Arm Description

Organosilane will be sprayed on the surfaces, using an atomizer. When the environment has been completely covered (i.e., when all surfaces and equipment have a slightly damp film), we will proceed with the second phase of the disinfection of all heavily touched surfaces. surfaces of the bed, with a microfiber cloth with organosilane.

The control group will perform standard cleaning and disinfection of the beds and the environment according to their previous protocols, using the usual products.

Outcomes

Primary Outcome Measures

Incidence of healthcare associated infections

Secondary Outcome Measures

Contamination of environmental surfaces by multi-resistant microorganisms
We will collect environmental samples from 4 surfaces highly touched by the patient, health team and family (bed rails, monitor and infusion pump buttons, meal table or procedure table, and IV drip stand) before and after the intervention. (end of the 6 months). For analysis of the environmental samples, characterization of the density and microbiological profile of biofilms on the different surfaces of the ICU beds will be performed using large-scale DNA sequencing techniques associated with bioinformatics analysis.
Incidence of ventilator-associated pneumonia
Incidence of central line-associated blood stream infections
Incidence of catheter-associated urinary tract infection
Intensive care unit length of stay costs

Full Information

First Posted
December 7, 2022
Last Updated
October 3, 2023
Sponsor
Hospital Israelita Albert Einstein
Collaborators
Hospital Sirio-Libanes, Hospital Moinhos de Vento, Hospital Alemão Oswaldo Cruz, Hospital do Coracao, Beneficência Portuguesa de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05673226
Brief Title
Organosilane for Surface Cleaning in Intensive Care Units
Acronym
ORG-CLEAN
Official Title
Organosilane for Surface Cleaning in Intensive Care Units: A Cluster Randomized, Controlled, Crossover, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 9, 2023 (Anticipated)
Primary Completion Date
November 11, 2024 (Anticipated)
Study Completion Date
November 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein
Collaborators
Hospital Sirio-Libanes, Hospital Moinhos de Vento, Hospital Alemão Oswaldo Cruz, Hospital do Coracao, Beneficência Portuguesa de São Paulo

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate if surface disinfection with organosilane associated with traditional cleaning reduces the incidence of healthcare-associated infections (HAIs) in intensive care units when compared with traditional cleaning alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Hospital
Keywords
Infection Control, Infections, Intensive Care Units, Pneumonia, Ventilator Associated, Catheter-Related Infections, Urinary Tract Infections, Organosilanes, Costs and Cost Analyses

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Randomized, controlled, cluster, crossover, trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
13000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surface disinfection with organosilane
Arm Type
Experimental
Arm Description
Organosilane will be sprayed on the surfaces, using an atomizer. When the environment has been completely covered (i.e., when all surfaces and equipment have a slightly damp film), we will proceed with the second phase of the disinfection of all heavily touched surfaces. surfaces of the bed, with a microfiber cloth with organosilane.
Arm Title
Usual surface disinfection
Arm Type
No Intervention
Arm Description
The control group will perform standard cleaning and disinfection of the beds and the environment according to their previous protocols, using the usual products.
Intervention Type
Other
Intervention Name(s)
Surface disinfection with Organosilane
Intervention Description
Organosilane will be sprayed on the surfaces, using an atomizer. When the environment has been completely covered (i.e., when all surfaces and equipment have a slightly damp film), we will proceed with the second phase of the disinfection of all heavily touched surfaces. surfaces of the bed, with a microfiber cloth with organosilane.
Primary Outcome Measure Information:
Title
Incidence of healthcare associated infections
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Contamination of environmental surfaces by multi-resistant microorganisms
Description
We will collect environmental samples from 4 surfaces highly touched by the patient, health team and family (bed rails, monitor and infusion pump buttons, meal table or procedure table, and IV drip stand) before and after the intervention. (end of the 6 months). For analysis of the environmental samples, characterization of the density and microbiological profile of biofilms on the different surfaces of the ICU beds will be performed using large-scale DNA sequencing techniques associated with bioinformatics analysis.
Time Frame
6 months
Title
Incidence of ventilator-associated pneumonia
Time Frame
6 months
Title
Incidence of central line-associated blood stream infections
Time Frame
6 months
Title
Incidence of catheter-associated urinary tract infection
Time Frame
6 months
Title
Intensive care unit length of stay costs
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients aged 18 years and older who will be admitted to the participating ICUs Exclusion Criteria: Patients under 18 years ICUs that may use any organosilane formulation for surface disinfection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio P Nassar Jr, PhD
Phone
551121519617
Email
antonio.nassar@einstein.br
First Name & Middle Initial & Last Name or Official Title & Degree
Adriano J Pereira, PhD
Phone
551121519617
Email
Adriano.Pereira2@einstein.br
Facility Information:
Facility Name
Santa Casa de Misericórdia
City
Belo Horizonte
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Priscila Bonisson
Facility Name
Hospital Jean Bittar
City
Belém
Country
Brazil
Facility Name
Hospital de Base do Distrito Federal
City
Brasília
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tazio Vanni
Facility Name
Hospital Universitário de Brasília
City
Brasília
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valéria Lima
Facility Name
Hospital Otoclínica
City
Fortaleza
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fábio Lacerda
Facility Name
Hospital do Tricentenário
City
Olinda
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Tereza F Moura
Facility Name
Hospital Escola Universidade Federal de Pelotas
City
Pelotas
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina P Bainy
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andréia Amorim
Facility Name
Hospital Ana Nery
City
Salvador
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Dorta
Facility Name
Hospital Santa Cruz
City
Santa Cruz Do Sul
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Foernges
Facility Name
Hospital Presidente Vargas
City
São Luís
Country
Brazil
Facility Name
A.C. Camargo Cancer Center
City
São Paulo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvana S Santos
Facility Name
Hospital do Coração
City
São Paulo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo Romano

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Organosilane for Surface Cleaning in Intensive Care Units

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