NCT06867458

Steriwave ICU Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Fraser Health · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, non-blinded, prospective, pilot study enrolling patients admitted to the critical care unit at Royal Columbian Hospital. This study investigates the effects of universal nasal decolonization using antimicrobial photodynamic therapy (aPDT) on the prevention of hospital-acquired pneumonia (HAP), ventilator-acquired pneumonia (VAP), and hospital-acquired bloodstream infection (BSI) in this patient population. Main Objectives include: * To determine whether a large, multi-center RCT of this protocol is feasible * To determine baseline rates of VAP, HAP, and ICU-acquired BSI * To gather preliminary efficacy data regarding VAP, HAP, and ICU-acquired BSI prevention using universal aPDT nasal decolonization * To gather preliminary microbiological data on the effect of universal aPDT procedures on nasal carriage of various microoganisms in ICU patients.

Conditions

• Ventilator Acquired Pneumonia
• Hospital Acquired Pneumonia
• Hospital Acquired Infections
• Nasal Decolonization of Staphylococcus Aureus

Interventions

Type	Name	Description
DEVICE	Antimicrobial photodynamic therapy (aPDT) nasal decolonization device	aPDT is a technique that employs a specific wavelength of light to activate a photosensitizer substance. Once activated, this photosensitizer reacts with surrounding molecules to produce radicals and reactive oxygen species. When activated in the presence of microorganisms, these molecules serve to disrupt membrane structure and protein cross-linking, leading to their death.

Timeline

• Start date: 2025-03-18
• Primary completion: 2025-07-18
• Completion: 2025-12-31
• First posted: 2025-03-10
• Last updated: 2026-03-05

Locations

1 site across 1 country: Canada