Preoperative Microbial Reduction of the Nasal Cavity With Antimicrobial Photodynamic Therapy (aPDT).
- Conditions
- Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT)
- Registration Number
- NCT06570252
- Lead Sponsor
- University of Zurich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 208
Inclusion Criteria:<br><br> - Provision of a signed and dated informed consent form<br><br> - Stated willingness to comply with all study procedures and availability for the<br> duration of the study<br><br> - Male or female = 18 years of age<br><br> - surgical intervention in general anesthesia at the department of Oral and<br> Maxillofacial Surgery of University Hospital Zurich<br><br>Exclusion Criteria:<br><br> - inability to tolerate insertion of the light illuminator or the photosensitizer<br> applicator due to anatomic variations (size, shape of oro-nasal region) or disease<br><br> - inability to follow the procedure of the investigation, e.g., due to language<br> problems or psychological disorders of the subject<br><br> - known allergic reactions to components of the nasal decolonization treatment,<br> including methylene blue or chlorhexidine gluconate<br><br> - planed surgery in the nasal cavity<br><br> - necessary nasal intubation for surgical intervention<br><br> - vulnerable persons (subjects incapable of judgment or subjects under tutelage)<br><br> - Pregnant or breastfeeding women
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27).
- Secondary Outcome Measures
Name Time Method Bacterial colonization 14 (+/-1) days after aPDT;Bacterial colonization 2 days after aPDT (only trauma surgery subgroup);Safety outcome