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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 208
- 主要终点
- Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27).
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Group - nasal aPDT
- Swabbing the formulation applicator (soft swab pre-saturated with the photosensitizer formulation) inside the patient's nostrils.
- 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.
- Experimental group: Activation of the light source and illumination of the nose and nasopharynx for 2 minutes.
- 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.
干预措施: activated Light Source (aPDT) (Device)
Control Group - no light activation
- Swabbing the formulation applicator (soft swab pre-saturated with the photosensitizer formulation) inside the patient's nostrils.
- 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.
- no activation of light source
- 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.
干预措施: non activated Light Source (Control) (Device)
结局指标
主要结局
Bacterial colonization 5 minutes after aPDT microbe groups, expressed as a score (range 0-27).
时间窗: 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
次要结局
- Safety outcome(day 1 and day 14 (+/-1))
- Bacterial colonization 2 days after aPDT (only trauma surgery subgroup)(2 days)
- Bacterial colonization 14 (+/-1) days after aPDT(14 (+/- 1) days)
研究者
Harald Essig
Prof. Dr. med. Dr. med. dent.; Clinical director a.i Department for Craniomaxillofacial Surgery
University of Zurich