Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT)NCT06570252
Preoperative Microbial Reduction of the Nasal Cavity With Antimicrobial Photodynamic Therapy (aPDT).
A study testing activated Light Source (aPDT) in people with Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT), run by University of Zurich.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT)
- What is being tested?
- activated Light Source (aPDT)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
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:
Read more
- 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:
- Nasal swab for baseline microbial colonization.
- Application of 0.2% chlorhexidine gluconate and methylene blue.
- 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.
- Nasal swab taken 5 minutes after the intervention to assess microbial reduction.
- Being tested
- activated Light Source (aPDT), non activated Light Source (Control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activated Light Source (aPDT)Device
Also called SteriwaveTM Nasal Photodisinfection System, SW4000 Light Source, SW3200 Nasal Light Illuminator, SW3100 Formulation Applicator
Application of SW3100 Formulation (0.2% chlorhexidine gluconate and methylene blue) in both nostrils followed by placing the SW3200 Nasal Light Illuminator with one channel per nostril.
Activation of SW4000 Light Source (Class 1 Laser Device) that generates red light consisting of 2 channels of 700 mW, 664 nm light (continuous wave) used to activate the disinfecting formulation.
Duration of illumination 2 minutes
non activated Light Source (Control)Device
Also called SW3100 Formulation Applicator, SW3200 Nasal Light Illuminator
Application of SW3100 Formulation (0.2% chlorhexidine gluconate and methylene blue) in both nostrils followed by placing the SW3200 Nasal Light Illuminator with one channel per nostril.
No activation of SW4000 Light Source
Waiting for 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group - nasal aPDT | Experimental | 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. Receives: Device: activated Light Source (aPDT) |
| Control Group - no light activation | Active comparator | 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. Receives: Device: non activated Light Source (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27).
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:
- ß-hemolytic (group A and group B) Streptococcus
- Staphylococcus aureus (with discrimination in MSSA and MRSA)
- Coagulase negative Staphylococcus species (incl. Staphylococcus epidermidis)
- a-hemolytic Streptococcus species (oral or viridans-group Streptococci)
- Corynebacterium species
- Candida species
- Enterobacterales
- Actinomyces species and miscellaneous aerotolerant bacteria
- Anaerobic bacteria with focus on Propionibacterium
Measured: 5 minutes after Intervention
Secondary outcomes (3)
Bacterial colonization 14 (+/-1) days after aPDT
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:
- ß-hemolytic (group A and group B) Streptococcus
- Staphylococcus aureus (with discrimination in MSSA and MRSA)
- Coagulase negative Staphylococcus species (incl. Staphylococcus epidermidis)
- a-hemolytic Streptococcus species (oral or viridans-group Streptococci)
- Corynebacterium species
- Candida species
- Enterobacterales
- Actinomyces species and miscellaneous aerotolerant bacteria
- Anaerobic bacteria with focus on Propionibacterium
Measured: 14 (+/- 1) days
Bacterial colonization 2 days after aPDT (only trauma surgery subgroup)
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:
- ß-hemolytic (group A and group B) Streptococcus
- Staphylococcus aureus (with discrimination in MSSA and MRSA)
- Coagulase negative Staphylococcus species (incl. Staphylococcus epidermidis)
- a-hemolytic Streptococcus species (oral or viridans-group Streptococci)
- Corynebacterium species
- Candida species
- Enterobacterales
- Actinomyces species and miscellaneous aerotolerant bacteria
- Anaerobic bacteria with focus on Propionibacterium
Measured: 2 days
Safety outcome
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.
Measured: day 1 and day 14 (+/-1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Ondine Biomedical Inc., University Hospital, Zürich
- Responsible party
- Principal investigator, Harald Essig, University of Zurich
- Investigators
- Harald Essig, Prof Dr Dr, Principal investigator, University Hospital Zürich, Department for Oral- and Maxillofacial Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570252
- Sponsor's protocol ID
- Nasal aPDT 01
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06570252
- Acronym / sponsor ID
- Nasal aPDT 01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Ondine Biomedical Inc., University Hospital, Zürich
- Study start
- Oct 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Nasal swab for baseline microbial colonization.
- Application of 0.2% chlorhexidine gluconate and methylene blue.
- 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.
- Nasal swab taken 5 minutes after the intervention to assess microbial reduction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - nasal aPDT | Experimental | Device: 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 | Active comparator | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activated Light Source (aPDT)Also: SteriwaveTM Nasal Photodisinfection System, SW4000 Light Source, SW3200 Nasal Light Illuminator, SW3100 Formulation ApplicatorApplication of SW3100 Formulation (0.2% chlorhexidine gluconate and methylene blue) in both nostrils followed by placing the SW3200 Nasal Light Illuminator with one channel per nostril. Activation of SW4000 Light Source (Class 1 Laser Device) that generates red light consisting of 2 channels of 700 mW, 664 nm light (continuous wave) used to activate the disinfecting formulation. Duration of illumination 2 minutes | Device | Experimental Group - nasal aPDT |
| non activated Light Source (Control)Also: SW3100 Formulation Applicator, SW3200 Nasal Light IlluminatorApplication of SW3100 Formulation (0.2% chlorhexidine gluconate and methylene blue) in both nostrils followed by placing the SW3200 Nasal Light Illuminator with one channel per nostril. No activation of SW4000 Light Source Waiting for 2 minutes | Device | Control Group - no light activation |
Primary outcome
Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27).
Time frame: 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
3 secondary outcomes
Bacterial colonization 14 (+/-1) days after aPDT
Time frame: 14 (+/- 1) days
Bacterial colonization 2 days after aPDT (only trauma surgery subgroup)
Time frame: 2 days
Safety outcome
Time frame: day 1 and day 14 (+/-1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Essig, Prof Dr Dr principal investigator
University Hospital Zürich, Department for Oral- and Maxillofacial Surgery
Questions about this trial
What is this clinical trial studying?
A study testing activated Light Source (aPDT) in people with Efficacy of Preoperative Microbial Reduction in the Nasal Cavity Using Antimicrobial Photodynamic Therapy (aPDT), run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregoire Longchamp, Dr (+41 44 255 30 58, gregoire.longchamp@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27). (time frame: 5 minutes after Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.