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

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia, Ventilator-Associated; Nosocomial Infections
• Intervention / Treatment: Device: CytaCoat Nasal Prong; Device: Inspiration Healthcare Inspire nCPAP Nasal Prong

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 171 76
      • Neonatal, Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CytaCoat Nasal Prong; The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.	Device: CytaCoat Nasal Prong
Active Comparator: Reference Nasal Prong; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: CytaCoat AB
• Investigators: Principal Investigator: Baldvin Jonsson, Neonatal, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): April 29, 2016

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Cross Infection
• Other Study ID Numbers: CCNP-01