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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
Sponsored by
CytaCoat AB
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

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

First Posted
April 26, 2016
Last Updated
December 8, 2016
Sponsor
CytaCoat AB
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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
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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