Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT)
Conditions
Brief 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.
Interventions
DEVICEactivated 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
DEVICEnon 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
Ondine Biomedical Inc.
University Hospital, Zürich, Innovation Pool
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27). | 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: 1. ß-hemolytic (group A and group B) Streptococcus 2. Staphylococcus aureus (with discrimination in MSSA and MRSA) 3. Coagulase negative Staphylococcus species (incl. Staphylococcus epidermidis) 4. a-hemolytic Streptococcus species (oral or viridans-group Streptococci) 5. Corynebacterium species 6. Candida species 7. Enterobacterales 8. Actinomyces species and miscellaneous aerotolerant bacteria 9. Anaerobic bacteria with focus on Propionibacterium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bacterial colonization 14 (+/-1) days after aPDT | 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: 1. ß-hemolytic (group A and group B) Streptococcus 2. Staphylococcus aureus (with discrimination in MSSA and MRSA) 3. Coagulase negative Staphylococcus species (incl. Staphylococcus epidermidis) 4. a-hemolytic Streptococcus species (oral or viridans-group Streptococci) 5. Corynebacterium species 6. Candida species 7. Enterobacterales 8. Actinomyces species and miscellaneous aerotolerant bacteria 9. Anaerobic bacteria with focus on Propionibacterium |
| Bacterial colonization 2 days after aPDT (only trauma surgery subgroup) | 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: 1. ß-hemolytic (group A and group B) Streptococcus 2. Staphylococcus aureus (with discrimination in MSSA and MRSA) 3. Coagulase negative Staphylococcus species (incl. Staphylococcus epidermidis) 4. a-hemolytic Streptococcus species (oral or viridans-group Streptococci) 5. Corynebacterium species 6. Candida species 7. Enterobacterales 8. Actinomyces species and miscellaneous aerotolerant bacteria 9. Anaerobic bacteria with focus on Propionibacterium |
| Safety outcome | 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. |
Contacts
Primary ContactGregoire Longchamp, Dr
Backup ContactMaximilian A Ries
Outcome results
None listed