Clinical trial NCT06570252: Preoperative Microbial Reduction of the Nasal Cavity With Antimicrobial Photodynamic Therapy (aPDT).
Official 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT)
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Ondine Biomedical Inc.
name: University Hospital, Zürich, Innovation Pool
First posted: 2024-08-26
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27).
timeFrame: 5 minutes after Intervention
Secondary outcomes:
measure: Bacterial colonization 14 (+/-1) days after aPDT
timeFrame: 14 (+/- 1) days
measure: Bacterial colonization 2 days after aPDT (only trauma surgery subgroup)
timeFrame: 2 days
measure: Safety outcome
timeFrame: day 1 and day 14 (+/-1)
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Zürich, Department for Oral- and Maxillofacial Surgery
name: Harald Essig, Prof Dr Dr
role: PRINCIPAL_INVESTIGATOR
References: