Preoperative Microbial Reduction of the Nasal Cavity With Antimicrobial Photodynamic Therapy (aPDT).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: activated Light Source (aPDT), non activated Light Source (Control).
- Who it may be relevant to
- Registry conditions: Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
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
Primary outcome measures
- Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27). [Time frame: 5 minutes after Intervention]
Secondary outcome measures (3)
- Bacterial colonization 14 (+/-1) days after aPDT [Time frame: 14 (+/- 1) days]
- Bacterial colonization 2 days after aPDT (only trauma surgery subgroup) [Time frame: 2 days]
- Safety outcome [Time frame: day 1 and day 14 (+/-1)]
Eligibility criteria
Inclusion criteria
- Provision of a signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female ≥ 18 years of age
- surgical intervention in general anesthesia at the department of Oral and Maxillofacial Surgery of University Hospital Zurich
Exclusion criteria
- inability to tolerate insertion of the light illuminator or the photosensitizer applicator due to anatomic variations (size, shape of oro-nasal region) or disease
- inability to follow the procedure of the investigation, e.g., due to language problems or psychological disorders of the subject
- known allergic reactions to components of the nasal decolonization treatment, including methylene blue or chlorhexidine gluconate
- planed surgery in the nasal cavity
- necessary nasal intubation for surgical intervention
- vulnerable persons (subjects incapable of judgment or subjects under tutelage)
- Pregnant or breastfeeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06570252 · Nasal aPDT 01