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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT)
• Intervention / Treatment: Device: activated Light Source (aPDT); Device: non activated Light Source (Control)

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregoire Longchamp, Dr; Phone Number: +41 44 255 30 58; Email: gregoire.longchamp@usz.ch
• Study Contact Backup: Name: Maximilian A Ries; Phone Number: +41 43 253 24 65; Email: maximilianalois.ries@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group - nasal aPDT; Swabbing the formulation applicator (soft swab pre-saturated with the photosensitizer formulation) inside the patient's nostrils.; 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.; Experimental group: Activation of the light source and illumination of the nose and nasopharynx for 2 minutes.; 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.	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; Other Names: SteriwaveTM Nasal Photodisinfection System; SW4000 Light Source; SW3200 Nasal Light Illuminator; SW3100 Formulation Applicator
Active Comparator: Control Group - no light activation; Swabbing the formulation applicator (soft swab pre-saturated with the photosensitizer formulation) inside the patient's nostrils.; 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.; no activation of light source; 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.	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; Other Names: SW3200 Nasal Light Illuminator; SW3100 Formulation Applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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	5 minutes after Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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	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: 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	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)

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Ondine Biomedical Inc.; University of Zurich, Epidemiology, Biostatistics and Prevention Institute; University Hospital, Zürich, Innovation Pool; University of Zurich, Institute for Medical Microbiology
• Investigators: Principal Investigator: Harald Essig, Prof Dr Dr, University Hospital Zürich, Department for Oral- and Maxillofacial Surgery

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Nasal aPDT 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No