Organosilane for surface cleaning in intensive care units: protocol for a cluster randomized controlled trial with crossover

Abstract

Objective: To assess whether surface disinfection with organosilane in the intensive care unit reduces the occurrence of healthcare-associated infections. Methods: This multicenter, controlled, cluster-randomized trial includes 14 intensive care units in Brazil from November 2023 to December 2024. The local hygiene team of the included intensive care units will disinfect bed surfaces with organosilane or with usual care for 6 months, followed by a sequential crossover of another 6 months. The primary outcome is the incidence of healthcare-associated infections, specifically ventilator-associated pneumonia, central-line-associated bloodstream infections, and catheter-associated urinary tract infections. The secondary endpoints are the contamination of the environment by multidrug-resistant microorganisms (i.e., oxacillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, carbapenem-resistant Enterobacter, Pseudomonas, and Acinetobacter), the incidence of specific infections (i.e., ventilator-associated pneumonia, central-line associated bloodstream infection, and catheter-associated urinary tract infection) and the cost of the patient’s intensive care unit stay. We will enroll all adult patients admitted after the study begins in each participant’s intensive care unit. Ethics and dissemination: The institutional review board of the coordinator center and each enrolled center approved the study protocol. We will disseminate the results in peer-reviewed journals and at scientific meetings, regardless of the study’s outcome.