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

NCT06570252 | Not Yet Recruiting DMC

• 1 other identifier: Nasal aPDT 01
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

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:
• Nasal swab for baseline microbial colonization.
• Application of 0.2% chlorhexidine gluconate and methylene blue.
• 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.
• Nasal swab taken 5 minutes after the intervention to assess microbial reduction.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  14 (+/- 1) days

• Bacterial colonization 2 days after aPDT (only trauma surgery subgroup)

  2 days

• Safety outcome

  day 1 and day 14 (+/-1)

Study Arms (2)

Experimental Group - nasal aPDT

EXPERIMENTAL

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.

Device: activated Light Source (aPDT)

Control Group - no light activation

ACTIVE COMPARATOR

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.

Device: non activated Light Source (Control)

Interventions

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

Also known as: SteriwaveTM Nasal Photodisinfection System, SW4000 Light Source, SW3200 Nasal Light Illuminator, SW3100 Formulation Applicator

Experimental Group - nasal aPDT

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

Also known as: SW3100 Formulation Applicator, SW3200 Nasal Light Illuminator

Control Group - no light activation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Ondine Biomedical Inc.: collaborator
• University Hospital, Zürich, Innovation Pool: collaborator

Study Officials

• Harald Essig, Prof Dr Dr

  University Hospital Zürich, Department for Oral- and Maxillofacial Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregoire Longchamp, Dr

CONTACT

+41 44 255 30 58; gregoire.longchamp@usz.ch

Maximilian A Ries

CONTACT

+41 43 253 24 65; maximilianalois.ries@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Dr. med. dent.; Clinical director a.i Department for Craniomaxillofacial Surgery

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: October 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08