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

University of Zurich (UZH)

Status: Not yet enrolling

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

Treatments: Device: activated Light Source (aPDT); Device: non activated Light Source (Control)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06570252

Nasal aPDT 01

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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208 participants in 2 patient groups

Experimental Group - nasal aPDT

Experimental group

Description:

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.

Treatment:

Device: activated Light Source (aPDT)

Control Group - no light activation

Active Comparator group

Description:

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.

Treatment:

Device: non activated Light Source (Control)