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

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

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

Sponsors & Collaborators

• Ondine Biomedical Inc.

  collaborator INDUSTRY

• University Hospital, Zürich, Innovation Pool

  collaborator UNKNOWN

• University of Zurich

  lead OTHER

Principal Investigators

• Harald Essig, Prof Dr Dr · University Hospital Zürich, Department for Oral- and Maxillofacial Surgery

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-31

Primary Completion

2026-02-28

Completion

2026-08-31