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

Pneumonia, Ventilator-Associated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756351
• Other study ID #: CCNP-01
• Status: Completed
• Phase: N/A
• First received: April 26, 2016
• Last updated: July 19, 2016
• Start date: April 2016
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: CytaCoat AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cross Infection
• Nosocomial Infections
• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

Device:
• CytaCoat Nasal Prong

• Inspiration Healthcare Inspire nCPAP Nasal Prong

Locations

Country	Name	City	State
Sweden	Neonatal, Karolinska University Hospital	Stockholm	Stockholm County

Sponsors (1)

Lead Sponsor	Collaborator
CytaCoat AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes