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

CytaCoat

Status: Completed

Conditions: Pneumonia, Ventilator-Associated; Nosocomial Infections

Treatments: Device: CytaCoat Nasal Prong; Device: Inspiration Healthcare Inspire nCPAP Nasal Prong

Study type: Interventional

Funder types: Industry

Identifiers

NCT02756351

CCNP-01

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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).
2. Subject is between 18 and 65 years of age.
3. Subjects that have intact, wound free and scar free skin at the Nasal Prong target site.
4. Subject that have intact, irritation-free nasal mucus membrane.

Exclusion criteria

1. Pregnant or nursing women.
2. Subjects who are active smokers or using snuff.
3. Subjects currently suffering from a common cold, sinusitis, allergies or sleep apnea.
4. Subjects suffering from and/or subjects that have experienced nosebleed within 1 month prior to entering the study.
5. Subjects using and/or subjects that have used oral or topical antibiotics within 2 weeks prior to entering the study.
6. Subjects using and/or subjects that have used oral or topical anti-inflammatory drugs within 1 week prior to entering the study.
7. Subjects participating in any other clinical study.
8. Subjects diagnosed with any type of skin infection (bacterial, viral or fungal) or inflammatory skin disease including psoriasis, eczema or severe acne
9. Subjects diagnosed with any type disease affecting mucus membranes.
10. Subjects suffering from any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment.
11. Subjects who have a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the Nasal Prong target site
12. Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

CytaCoat Nasal Prong

Experimental group

Description:

The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.

Treatment:

Device: CytaCoat Nasal Prong

Reference Nasal Prong

Active Comparator group

Description:

Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.

Treatment:

Device: Inspiration Healthcare Inspire nCPAP Nasal Prong