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

NCT ID: NCT02756351

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-07-31

Brief Summary

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.

Conditions

Nosocomial Infections; Pneumonia, Ventilator-Associated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

CytaCoat Nasal Prong

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

Group Type: EXPERIMENTAL

CytaCoat Nasal Prong

Intervention Type: DEVICE

Reference Nasal Prong

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

Group Type: ACTIVE_COMPARATOR

Inspiration Healthcare Inspire nCPAP Nasal Prong

Intervention Type: DEVICE

Interventions

CytaCoat Nasal Prong

Intervention Type: DEVICE

Inspiration Healthcare Inspire nCPAP Nasal Prong

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CytaCoat AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baldvin Jonsson

Role: PRINCIPAL_INVESTIGATOR

Neonatal, Karolinska University Hospital

Locations

Neonatal, Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Countries

Sweden

Other Identifiers

CCNP-01

Identifier Type: -

Identifier Source: org_study_id