Organosilane for Surface Cleaning in Intensive Care Units

Infection, Hospital Clinical Trial

— ORG-CLEAN  

Official title:

Organosilane for Surface Cleaning in Intensive Care Units: A Cluster Randomized, Controlled, Crossover, Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673226
• Other study ID #: 52639521.1.1001.0071
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 6, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Hospital Israelita Albert Einstein
• Contact: Antonio P Nassar Jr, PhD
• Phone: 551121519617
• Email: antonio.nassar[@]einstein.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13000
• Est. completion date: December 30, 2024
• Est. primary completion date: November 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cross Infection
• Infection, Hospital
• Infections

Intervention

Other:
• Surface disinfection with Organosilane
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.

Locations

Country	Name	City	State
Brazil	Hospital Jean Bittar	Belém
Brazil	Santa Casa de Misericórdia	Belo Horizonte
Brazil	Hospital de Base do Distrito Federal	Brasília
Brazil	Hospital Universitário de Brasília	Brasília
Brazil	Hospital Otoclínica	Fortaleza
Brazil	Hospital Geral de Goiânia	Goiânia
Brazil	Hospital do Tricentenário	Olinda
Brazil	Hospital Escola Universidade Federal de Pelotas	Pelotas
Brazil	Hospital Ernesto Dornelles	Porto Alegre
Brazil	Hospital Ana Nery	Salvador
Brazil	Hospital Santa Cruz	Santa Cruz Do Sul
Brazil	Hospital Presidente Vargas	São Luís
Brazil	A.C. Camargo Cancer Center	São Paulo
Brazil	Hospital do Coração	São Paulo

Sponsors (6)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Beneficência Portuguesa de São Paulo, Hospital Alemão Oswaldo Cruz, Hospital do Coracao, Hospital Moinhos de Vento, Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of healthcare associated infections		6 months
Secondary	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.	6 months
Secondary	Incidence of ventilator-associated pneumonia		6 months
Secondary	Incidence of central line-associated blood stream infections		6 months
Secondary	Incidence of catheter-associated urinary tract infection		6 months
Secondary	Intensive care unit length of stay costs		6 months