Trial Outcomes & Findings for A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization (NCT NCT02756351)

NCT ID: NCT02756351

Last Updated: 2017-02-01

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

18 hours

Results posted on

2017-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	CytaCoat Nasal Prong The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat Nasal Prong	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
Overall Study STARTED	24	24
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CytaCoat Nasal Prong n=24 Participants The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat Nasal Prong	Reference Nasal Prong n=24 Participants 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	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=93 Participants	24 Participants n=4 Participants	48 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	33.96 years STANDARD_DEVIATION 14.22 • n=93 Participants	31.58 years STANDARD_DEVIATION 13.44 • n=4 Participants	32.77 years STANDARD_DEVIATION 13.74 • n=27 Participants
Gender Female	18 Participants n=93 Participants	21 Participants n=4 Participants	39 Participants n=27 Participants
Gender Male	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Region of Enrollment Sweden	24 participants n=93 Participants	24 participants n=4 Participants	48 participants n=27 Participants

PRIMARY outcome

Timeframe: 18 hours

Outcome measures

Outcome measures
Measure	CytaCoat Nasal Prong n=24 Participants The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat Nasal Prong	Reference Nasal Prong n=24 Participants 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
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 4.40	21.69 fold change in log value Standard Deviation 1.93

SECONDARY outcome

Timeframe: 18 hours

Outcome measures

Outcome measures
Measure	CytaCoat Nasal Prong n=24 Participants The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat Nasal Prong	Reference Nasal Prong n=24 Participants 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
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	23 Adverse Events

Adverse Events

CytaCoat Nasal Prong

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Reference Nasal Prong

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr Jacob Odeberg

CytaCoat AB

Phone: +46 (0) 70 2087571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee As stated in the Clinical Investigation Plan (CIP): The Principal Investigator may publish results from this investigation; however as some of the information regarding the investigational medical device and development activities may be of a strictly confidential nature, the Sponsor must first be given the opportunity to review any publication manuscript prior to submission to journals, meetings or conferences.
Publication restrictions are in place

Restriction type: OTHER

Measure	CytaCoat Nasal Prong n=24 participants at risk The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat Nasal Prong	Reference Nasal Prong n=24 participants at risk 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
Skin and subcutaneous tissue disorders Mark on columella	29.2% 7/24 • Number of events 7 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	20.8% 5/24 • Number of events 5 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Pain	20.8% 5/24 • Number of events 5 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	8.3% 2/24 • Number of events 2 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Mark on tip of the nose	20.8% 5/24 • Number of events 5 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Itch	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	8.3% 2/24 • Number of events 2 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Breathing problems	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Humidity	0.00% 0/24 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	8.3% 2/24 • Number of events 2 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Irritation and sore	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Itch and humidity	0.00% 0/24 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	8.3% 2/24 • Number of events 2 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Mark	0.00% 0/24 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	8.3% 2/24 • Number of events 2 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Social circumstances Psychological	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Sore	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Stingy	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Breathing problems and itch	0.00% 0/24 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Skin and subcutaneous tissue disorders Irritation and stingy	0.00% 0/24 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.
Social circumstances Sleepwalking, nausea and a feeling of fainting	4.2% 1/24 • Number of events 1 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.	0.00% 0/24 • Adverse Events were reported throughout the study, i.e. 15 March until 28 June 2016. For each subject Adverse Events were reported until the subject had completed the study, e.g. between Visit 1 and 2 (18 hours of participation). One subject was followed- up one extra day before the Adverse Event was assessed as resolved.