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

Not Applicable

Completed

• Conditions: Nosocomial Infections; Pneumonia, Ventilator-Associated
• Interventions: Device: Inspiration Healthcare Inspire nCPAP Nasal Prong; Device: CytaCoat Nasal Prong

• Registration Number: NCT02756351
• Lead Sponsor: CytaCoat AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-29
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2016-12
• Results First Submitted: 2016-12-08
• Results First Submitted QC: 2016-12-08
• Last Update Submitted: 2016-12-08
• Results First Posted: 2017-02-01
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference Nasal Prong	Inspiration Healthcare Inspire nCPAP Nasal Prong	Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.
CytaCoat Nasal Prong	CytaCoat Nasal Prong	The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Neonatal, Karolinska University Hospital; 🇸🇪 Stockholm, Stockholm County, Sweden