N/A
Completed N=48
A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
Nosocomial Infections · Pneumonia, Ventilator-Associated
Source: ClinicalTrials.gov NCT02756351 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: 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. — 8.29; 21.69 fold change in log value
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
8.29; 21.69 | — |
| SECONDARY 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. |
24; 23 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02756351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.