Organosilane for Surface Cleaning in Intensive Care Units

NCT05673226 | Completed DMC

• 1 other identifier: 52639521.1.1001.0071
• Study Type: interventional
• Target: 10,301
• Locations: 1 country
• Sites: 14

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.

Conditions

Infection, Hospital

Keywords

Infection Control; Infections; Intensive Care Units; Pneumonia, Ventilator Associated; Catheter-Related Infections; Urinary Tract Infections; Organosilanes; Costs and Cost Analyses

Outcome Measures

Primary Outcomes (1)

• Incidence of healthcare associated infections

  6 months

Secondary Outcomes (5)

• Contamination of environmental surfaces by multi-resistant microorganisms

  6 months

• Incidence of ventilator-associated pneumonia

  6 months

• Incidence of central line-associated blood stream infections

  6 months

• Incidence of catheter-associated urinary tract infection

  6 months

• Intensive care unit length of stay costs

  6 months

Study Arms (2)

Surface disinfection with organosilane

EXPERIMENTAL

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.

Other: Surface disinfection with Organosilane

Usual surface disinfection

NO INTERVENTION

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

Interventions

Surface disinfection with Organosilane OTHER

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.

Surface disinfection with organosilane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged 18 years and older who will be admitted to the participating ICUs

You may not qualify if:

• Patients under 18 years
• ICUs that may use any organosilane formulation for surface disinfection

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Hospital Sirio-Libanes: collaborator
• Hospital Moinhos de Vento: collaborator
• Hospital Alemão Oswaldo Cruz: collaborator
• Hospital do Coracao: collaborator
• Beneficência Portuguesa de São Paulo: collaborator

Study Sites (14)

Hospital Jean Bittar

Belém, Brazil

Location

Santa Casa de Misericórdia

Belo Horizonte, Brazil

Location

Hospital de Base do Distrito Federal

Brasília, Brazil

Location

Hospital Universitário de Brasília

Brasília, Brazil

Location

Hospital Otoclínica

Fortaleza, Brazil

Location

Hospital Geral de Goiânia

Goiânia, Brazil

Location

Hospital do Tricentenário

Olinda, Brazil

Location

Hospital Escola Universidade Federal de Pelotas

Pelotas, Brazil

Location

Hospital Ernesto Dornelles

Porto Alegre, Brazil

Location

Hospital Ana Nery

Salvador, Brazil

Location

Hospital Santa Cruz

Santa Cruz do Sul, Brazil

Location

Hospital Presidente Vargas

São Luís, Brazil

Location

A.C. Camargo Cancer Center

São Paulo, Brazil

Location

Hospital do Coração

São Paulo, Brazil

Location

MeSH Terms

Conditions

Cross Infection; Infections; Pneumonia, Ventilator-Associated; Catheter-Related Infections; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, cluster, crossover, trial

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 6, 2023
• Study Start: November 6, 2023
• Primary Completion: January 13, 2025
• Study Completion: January 30, 2025
• Last Updated: September 22, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

BR (14)