Preoperative Microbial Reduction of the Nasal Cavity With Antimicrobial Photodynamic Therapy (aPDT).
NCT Number: NCT06570252
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT)
Interventions: DEVICE: activated Light Source (aPDT)|DEVICE: non activated Light Source (Control)
Sponsor: University of Zurich
Collaborators: Ondine Biomedical Inc.|University Hospital, Zürich, Innovation Pool|University of Zurich, Institute for Medical Microbiology|University of Zurich, Epidemiology, Biostatistics and Prevention Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 208
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2026-08

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.

Primary Outcome Measures: Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27)., 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, 5 minutes after Intervention
Secondary Outcome Measures: Bacterial colonization 14 (+/-1) days after aPDT, 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, 14 (+/- 1) days|Bacterial colonization 2 days after aPDT (only trauma surgery subgroup), 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, 2 days|Safety outcome, 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., day 1 and day 14 (+/-1)