NCT06570252

Preoperative Microbial Reduction of the Nasal Cavity With Antimicrobial Photodynamic Therapy (aPDT).

A Randomized, Controlled, Double Blinded National Single-center Study to Evaluate the SteriwaveTM Antimicrobial Photodynamic Therapy System for Preoperative Nasal Cavity Decolonization in Adult Patients.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate the preoperative microbial reduction of the nasal cavity using Photodynamic Therapy (aPDT) in adult patients undergoing surgical intervention at the Department for Craniomaxillofacial Surgery, University Hospital Zurich, Switzerland. The main question the trial aims to answer is: \- Does aPDT reduce microbial colonization in the nasal cavity more effectively 5 minutes after treatment compared to the baseline (before intervention)? Participants will be randomized into two groups: * Study Group: Nasal cavity photodisinfection using aPDT. * Control Group: Treatment with 0.2% chlorhexidine gluconate and non-light activated methylene blue. Researchers will compare the effectiveness of aPDT against the control treatment in reducing microbial colonization of the nasal cavity. Study Procedure: 1. Nasal swab for baseline microbial colonization. 2. Application of 0.2% chlorhexidine gluconate and methylene blue. 3. Insertion of nasal light illuminator into the patient's nostrils: * Study Group: Activation of the light source. * Control Group: No activation of the light source. 4. Nasal swab taken 5 minutes after the intervention to assess microbial reduction.

Conditions

• Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT)

Interventions

Type	Name	Description
DEVICE	activated Light Source (aPDT)	Application of SW3100 Formulation (0.2% chlorhexidine gluconate and methylene blue) in both nostrils followed by placing the SW3200 Nasal Light Illuminator with one channel per nostril. Activation of SW4000 Light Source (Class 1 Laser Device) that generates red light consisting of 2 channels of 700 mW, 664 nm light (continuous wave) used to activate the disinfecting formulation. Duration of illumination 2 minutes
DEVICE	non activated Light Source (Control)	Application of SW3100 Formulation (0.2% chlorhexidine gluconate and methylene blue) in both nostrils followed by placing the SW3200 Nasal Light Illuminator with one channel per nostril. No activation of SW4000 Light Source Waiting for 2 minutes

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-02-01
• Completion: 2026-08-01
• First posted: 2024-08-26
• Last updated: 2024-08-26