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

Primary Purpose

Nosocomial Infections, Pneumonia, Ventilator-Associated

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

CytaCoat Nasal Prong

Inspiration Healthcare Inspire nCPAP Nasal Prong

About this trial

This is an interventional prevention trial for Nosocomial Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Neonatal, Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CytaCoat Nasal Prong

Reference Nasal Prong

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02756351

First Posted

April 26, 2016

Last Updated

December 8, 2016

Sponsor

CytaCoat AB

1. Study Identification

Unique Protocol Identification Number

NCT02756351

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

April 2016 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CytaCoat AB

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nosocomial Infections, Pneumonia, Ventilator-Associated

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CytaCoat Nasal Prong

Arm Type

Experimental

Arm Description

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

Arm Title

Reference Nasal Prong

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

CytaCoat Nasal Prong

Intervention Type

Device

Intervention Name(s)

Inspiration Healthcare Inspire nCPAP Nasal Prong

Primary Outcome Measure Information:

Title

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.

Time Frame

18 hours

Secondary Outcome Measure Information:

Title

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.

Time Frame

18 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Subject is between 18 and 65 years of age. Subjects that have intact, wound free and scar free skin at the Nasal Prong target site. Subject that have intact, irritation-free nasal mucus membrane. Exclusion Criteria: Pregnant or nursing women. Subjects who are active smokers or using snuff. Subjects currently suffering from a common cold, sinusitis, allergies or sleep apnea. Subjects suffering from and/or subjects that have experienced nosebleed within 1 month prior to entering the study. Subjects using and/or subjects that have used oral or topical antibiotics within 2 weeks prior to entering the study. Subjects using and/or subjects that have used oral or topical anti-inflammatory drugs within 1 week prior to entering the study. Subjects participating in any other clinical study. Subjects diagnosed with any type of skin infection (bacterial, viral or fungal) or inflammatory skin disease including psoriasis, eczema or severe acne Subjects diagnosed with any type disease affecting mucus membranes. Subjects suffering from any other condition or symptoms preventing the subject from entering the study, according to the investigator´s judgment. Subjects who have a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the Nasal Prong target site Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baldvin Jonsson

Organizational Affiliation

Neonatal, Karolinska University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neonatal, Karolinska University Hospital

City

Stockholm

State/Province

Stockholm County

ZIP/Postal Code

171 76

Country

Sweden

12. IPD Sharing Statement

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

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