A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
Not Applicable
Completed
- Conditions
- Nosocomial InfectionsPneumonia, Ventilator-Associated
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does CytaCoat technology use to reduce bacterial colonization on nasal prongs?
How does the efficacy of CytaCoat Nasal Prongs compare to standard nasal prongs in preventing ventilator-associated pneumonia?
Are there specific biomarkers that identify patients who would benefit most from CytaCoat nasal prongs in neonatal care?
What are the potential adverse events associated with the use of CytaCoat surface-coated nasal prongs in clinical settings?
What are the key competitors or alternative devices to CytaCoat Nasal Prongs for reducing nosocomial infections in neonatal units?
Trial Locations
- Locations (1)
Neonatal, Karolinska University Hospital
🇸🇪Stockholm, Stockholm County, Sweden
Neonatal, Karolinska University Hospital🇸🇪Stockholm, Stockholm County, Sweden