Status:
NOT_YET_RECRUITING
Preoperative Microbial Reduction of the Nasal Cavity With Antimicrobial Photodynamic Therapy (aPDT).
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Ondine Biomedical Inc.
University Hospital, Zürich, Innovation Pool
Conditions:
Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT)
Eligibility:
All Genders
18+ years
Phase:
NA
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 D...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT06570252
Start Date
October 1 2024
End Date
August 1 2026
Last Update
August 26 2024
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