Nosocomial Infections, Pneumonia, Ventilator-Associated
Conditions
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.
Interventions
DEVICECytaCoat Nasal Prong
DEVICEInspiration Healthcare Inspire nCPAP Nasal Prong
Sponsors
CytaCoat AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CytaCoat Nasal Prong The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.
CytaCoat Nasal Prong | 24 |
| Reference Nasal Prong Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.
Inspiration Healthcare Inspire nCPAP Nasal Prong | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | Reference Nasal Prong | CytaCoat Nasal Prong | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 24 Participants | 48 Participants |
| Age, Continuous | 31.58 years STANDARD_DEVIATION 13.44 | 33.96 years STANDARD_DEVIATION 14.22 | 32.77 years STANDARD_DEVIATION 13.74 |
| Gender Female | 21 Participants | 18 Participants | 39 Participants |
| Gender Male | 3 Participants | 6 Participants | 9 Participants |
| Region of Enrollment Sweden | 24 participants | 24 participants | 48 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 24 | 16 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
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.
Time frame: 18 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CytaCoat Nasal Prong | 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 fold change in log value | Standard Deviation 4.4 |
| Reference Nasal Prong | 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. | 21.69 fold change in log value | Standard Deviation 1.93 |
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.
Time frame: 18 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CytaCoat Nasal Prong | 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 Adverse Events |
| Reference Nasal Prong | 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. | 23 Adverse Events |