A Double-blinded Randomized Clinical Pilot Trial of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CytaCoat AB
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Mean Difference in Bacterial Colonization of the Nasal Prong After 18 Hours of Device Usage When Comparing the CytaCoat Nasal Prong to the Reference Device.
研究概览
简要总结
The study is a first step in establishing the safety and efficacy of the CytaCoat technology when applied to a medical device such as a nasal prong and the clinical data generated will serve as a basis for continuous studies in clinically significant settings such as the neonatal care units.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF).
- •Subject is between 18 and 65 years of age.
- •Subjects that have intact, wound free and scar free skin at the Nasal Prong target site.
- •Subject that have intact, irritation-free nasal mucus membrane.
排除标准
- •Pregnant or nursing women.
- •Subjects who are active smokers or using snuff.
- •Subjects currently suffering from a common cold, sinusitis, allergies or sleep apnea.
- •Subjects suffering from and/or subjects that have experienced nosebleed within 1 month prior to entering the study.
- •Subjects using and/or subjects that have used oral or topical antibiotics within 2 weeks prior to entering the study.
- •Subjects using and/or subjects that have used oral or topical anti-inflammatory drugs within 1 week prior to entering the study.
- •Subjects participating in any other clinical study.
- •Subjects diagnosed with any type of skin infection (bacterial, viral or fungal) or inflammatory skin disease including psoriasis, eczema or severe acne
- •Subjects diagnosed with any type disease affecting mucus membranes.
- •Subjects suffering from any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment.
- •Subjects who have a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the Nasal Prong target site
- •Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment.
研究组 & 干预措施
CytaCoat Nasal Prong
The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.
干预措施: CytaCoat Nasal Prong (Device)
Reference Nasal Prong
Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.
干预措施: Inspiration Healthcare Inspire nCPAP Nasal Prong (Device)
结局指标
主要结局
Mean Difference in Bacterial Colonization of the Nasal Prong After 18 Hours of Device Usage When Comparing the CytaCoat Nasal Prong to the Reference Device.
时间窗: 18 hours
次要结局
- Any Adverse Events Such as Skin Reactions, Allergic Reactions, Abrasions, Shears or Wounds Due to Contact or Pressure of the Device on the Nose of Subjects Occurring During the Study.(18 hours)