Preoperative Microbial Reduction of the Nasal Cavity With Antimicrobial Photodynamic Therapy (aPDT).
NCT ID: NCT06570252
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
208 participants
INTERVENTIONAL
2024-10-31
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study
NCT04067843
Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II)
NCT04618276
Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-III)
NCT05676801
Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds
NCT02392390
Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers
NCT04285710
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Group - nasal aPDT
1. Swabbing the formulation applicator (soft swab pre-saturated with the photosensitizer formulation) inside the patient's nostrils.
2. Connection of the nasal light illuminator to the light source and insertion of the nasal light illuminator into the patient's right and left nostrils.
3. Experimental group: Activation of the light source and illumination of the nose and nasopharynx for 2 minutes.
4. Repetition of steps 1.-3. to complete photo disinfection of all nasal regions.
Duration of study intervention: 14 minutes
Intervention is performed during preparations prior to surgery and followed by regular disinfection of oral cavity (not nasal cavity) according to hospital standards after nasal swab test.
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
Control Group - no light activation
1. Swabbing the formulation applicator (soft swab pre-saturated with the photosensitizer formulation) inside the patient's nostrils.
2. Connection of the nasal light illuminator to the light source and insertion of the nasal light illuminator into the patient's right and left nostrils.
3. no activation of light source
4. Repetition of steps 1.-3. to complete control intervention.
Duration of treatment: 14 minutes
Intervention is performed during preparations prior to surgery and followed by regular disinfection of oral cavity (not nasal cavity) according to hospital standards after nasal swab test.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ondine Biomedical Inc.
INDUSTRY
University Hospital, Zürich, Innovation Pool
UNKNOWN
University of Zurich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Harald Essig
Prof. Dr. med. Dr. med. dent.; Clinical director a.i Department for Craniomaxillofacial Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Harald Essig, Prof Dr Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zürich, Department for Oral- and Maxillofacial Surgery
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Nasal aPDT 01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.