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NCT Number: NCT06570252

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated Light Source (aPDT)

Device

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

Other names: SteriwaveTM Nasal Photodisinfection System, SW4000 Light Source, SW3200 Nasal Light Illuminator, SW3100 Formulation Applicator

non activated Light Source (Control)

Device

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 names: SW3100 Formulation Applicator, SW3200 Nasal Light Illuminator

Primary outcomes

Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27).

Time frame: 5 minutes after Intervention
Relative abundance of CFU (colony forming unit) over nine analyzed microbe groups (expressed as score (range 0-27)) adjusted to the baseline measure 3 minutes pre-intervention.

Name CFU's Score "not detectable" below detection limit 0 "sporadic" <10^4 1 "moderate" 10^4 - 10^5 2 "plentful" >10^5 3

Nine microbial subgroups for analysis:
- ß-hemolytic (group A and group B) Streptococcus
- Staphylococcus aureus (with discrimination in MSSA and MRSA)
- Coagulase negative Staphylococcus species (incl. Staphylococcus epidermidis)
- a-hemolytic Streptococcus species (oral or viridans-group Streptococci)
- Corynebacterium species
- Candida species
- Enterobacterales
- Actinomyces species and miscellaneous aerotolerant bacteria
- Anaerobic bacteria with focus on Propionibacterium

Secondary outcomes

Bacterial colonization 14 (+/-1) days after aPDT

Time frame: 14 (+/- 1) days
Bacterial colonization 14 (+/-1) days after aPDT across the nine analyzed microbe groups and expressed as score (range 0-27).

Name CFU's Score "not detectable" below detection limit 0 "sporadic" <10^4 1 "moderate" 10^4 - 10^5 2 "plentful" >10^5 3

Nine microbial subgroups for analysis:
- ß-hemolytic (group A and group B) Streptococcus
- Staphylococcus aureus (with discrimination in MSSA and MRSA)
- Coagulase negative Staphylococcus species (incl. Staphylococcus epidermidis)
- a-hemolytic Streptococcus species (oral or viridans-group Streptococci)
- Corynebacterium species
- Candida species
- Enterobacterales
- Actinomyces species and miscellaneous aerotolerant bacteria
- Anaerobic bacteria with focus on Propionibacterium
Bacterial colonization 2 days after aPDT (only trauma surgery subgroup)

Time frame: 2 days
Bacterial colonization 2 days after aPDT in the midface trauma subgroup across the nine analyzed microbe groups and expressed as score (range 0-27).

Name CFU's Score "not detectable" below detection limit 0 "sporadic" <10^4 1 "moderate" 10^4 - 10^5 2 "plentful" >10^5 3

Nine microbial subgroups for analysis:
- ß-hemolytic (group A and group B) Streptococcus
- Staphylococcus aureus (with discrimination in MSSA and MRSA)
- Coagulase negative Staphylococcus species (incl. Staphylococcus epidermidis)
- a-hemolytic Streptococcus species (oral or viridans-group Streptococci)
- Corynebacterium species
- Candida species
- Enterobacterales
- Actinomyces species and miscellaneous aerotolerant bacteria
- Anaerobic bacteria with focus on Propionibacterium
Safety outcome

Time frame: day 1 and day 14 (+/-1)

Standardized survey for adverse effects noted after treatment and on day 1 and day 14 (+/-1) during regular follow-up consultation after surgery. For outpatient procedures, side effects are surveyed after treatment on the first day as a telephone conversation.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregoire Longchamp, Dr

CONTACT

[email protected]

+41 44 255 30 58

Maximilian A Ries

CONTACT

[email protected]

+41 43 253 24 65

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

Ondine Biomedical Inc.
University Hospital, Zürich

Registry information

Official study 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.

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Aug 26, 2024
Registry last updated: Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.