A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blinded Randomized Clinical Pilot Trial of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization

Conditions
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Nosocomial Infections, Pneumonia, Ventilator-Associated

Intervention / Treatment
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* Device: CytaCoat Nasal Prong
* Device: Inspiration Healthcare Inspire nCPAP Nasal Prong


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CytaCoat Nasal Prong<br>The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. | Device: CytaCoat Nasal Prong<br> <br> |
| Active Comparator: Reference Nasal Prong<br>Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device. | Device: Inspiration Healthcare Inspire nCPAP Nasal Prong<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 18 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |