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)
- Interventions
- Device: activated Light Source (aPDT)Device: non activated Light Source (Control)
- Registration Number
- NCT06570252
- Lead Sponsor
- University of Zurich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 208
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group - nasal aPDT activated Light Source (aPDT) 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. Control Group - no light activation non activated Light Source (Control) 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.
- Primary Outcome Measures
Name Time Method Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27). 5 minutes after Intervention 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
- Secondary Outcome Measures
Name Time Method Bacterial colonization 2 days after aPDT (only trauma surgery subgroup) 2 days Bacterial colonization 2 days after aPDT in the midface trauma subgroup across the nine analyzed microbe groups and expressed as score (range 0-27).
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 PropionibacteriumSafety outcome day 1 and day 14 (+/-1) Standardized survey for adverse effects noted after treatment and on day 1 and day 14 (+/-1) during regular follow-up consultation after surgery. For outpatient procedures, side effects are surveyed after treatment on the first day as a telephone conversation.
Bacterial colonization 14 (+/-1) days after aPDT 14 (+/- 1) days Bacterial colonization 14 (+/-1) days after aPDT across the nine analyzed microbe groups and expressed as score (range 0-27).
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