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| Name | Class |
|---|---|
| Ondine Biomedical Inc. | INDUSTRY |
| University Hospital, Zürich | OTHER |
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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:
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:
Nasal swab taken 5 minutes after the intervention to assess microbial reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group - nasal aPDT | Experimental |
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 |
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated Light Source (aPDT) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 5 minutes after Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregoire Longchamp, Dr | Contact | +41 44 255 30 58 | gregoire.longchamp@usz.ch | |
| Maximilian A Ries | Contact | +41 43 253 24 65 | maximilianalois.ries@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Harald Essig, Prof Dr Dr | University Hospital Zürich, Department for Oral- and Maxillofacial Surgery | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2024 |
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| non activated Light Source (Control) | Device | 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 |
|
|
| 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:
| 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. | day 1 and day 14 (+/-1) |
| Aug 22, 2024 |
| Prot_SAP_000.pdf |