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OpenTrials
Completed

NCT Number: NCT02756351

A Efficacy and Safety Study 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal, Karolinska University Hospital

Stockholm, Stockholm County, 171 76, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CytaCoat Nasal Prong

Device

Inspiration Healthcare Inspire nCPAP Nasal Prong

Device

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

CytaCoat AB

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2016
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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