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

• Sponsor: CytaCoat AB (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02756351
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 16.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nosocomial Infections; Pneumonia, Ventilator-Associated	Device: CytaCoat Nasal Prong; Device: Inspiration Healthcare Inspire nCPAP Nasal Prong	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: A Double-blinded Randomized Clinical Pilot Trial of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CytaCoat Nasal Prong The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.	Device: CytaCoat Nasal Prong
Active Comparator: Reference Nasal Prong Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.	Device: Inspiration Healthcare Inspire nCPAP Nasal Prong

Outcome Measures

Primary Outcome Measures

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. [18 hours]

Secondary Outcome Measures

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. [18 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neonatal, Karolinska University Hospital	Stockholm	Stockholm County	Sweden	171 76

Sponsors and Collaborators

• CytaCoat AB

Investigators

• Principal Investigator: Baldvin Jonsson, Neonatal, Karolinska University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CytaCoat AB
• ClinicalTrials.gov Identifier: NCT02756351
• Other Study ID Numbers: CCNP-01
• First Posted: Apr 29, 2016
• Last Update Posted: Feb 1, 2017
• Last Verified: Dec 1, 2016

• Additional relevant MeSH terms: Cross Infection; Pneumonia, Ventilator-Associated

Study Results

Participant Flow

Arm/Group Title	CytaCoat Nasal Prong	Reference Nasal Prong
Arm/Group Description	The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat 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
Period Title: Overall Study
STARTED	24	24
COMPLETED	24	24
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	CytaCoat Nasal Prong	Reference Nasal Prong	Total
Arm/Group Description	The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat 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	Total of all reporting groups
Overall Participants	24	24	48
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	24 100%	24 100%	48 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.96 (14.22)	31.58 (13.44)	32.77 (13.74)
Gender (Count of Participants)
Female	18 75%	21 87.5%	39 81.3%
Male	6 25%	3 12.5%	9 18.8%
Region of Enrollment (participants) [Number]
Sweden	24 100%	24 100%	48 100%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CytaCoat Nasal Prong	Reference Nasal Prong
Arm/Group Description	The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat 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
Measure Participants	24	24
Mean (Standard Deviation) [fold change in log value]	8.29 (4.40)	21.69 (1.93)

2. Secondary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CytaCoat Nasal Prong	Reference Nasal Prong
Arm/Group Description	The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat 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
Measure Participants	24	24
Number [Adverse Events]	24	23

Adverse Events

Time Frame	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.
Arm/Group Title	CytaCoat Nasal Prong		Reference Nasal Prong
Arm/Group Description	The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology. CytaCoat 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
All Cause Mortality
	CytaCoat Nasal Prong		Reference Nasal Prong
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CytaCoat Nasal Prong		Reference Nasal Prong
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	CytaCoat Nasal Prong		Reference Nasal Prong
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/24 (70.8%)		16/24 (66.7%)
Skin and subcutaneous tissue disorders
Mark on columella	7/24 (29.2%)	7	5/24 (20.8%)	5
Pain	5/24 (20.8%)	5	2/24 (8.3%)	2
Mark on tip of the nose	5/24 (20.8%)	5	1/24 (4.2%)	1
Itch	1/24 (4.2%)	1	2/24 (8.3%)	2
Breathing problems	1/24 (4.2%)	1	1/24 (4.2%)	1
Humidity	0/24 (0%)	0	2/24 (8.3%)	2
Irritation and sore	1/24 (4.2%)	1	1/24 (4.2%)	1
Itch and humidity	0/24 (0%)	0	2/24 (8.3%)	2
Mark	0/24 (0%)	0	2/24 (8.3%)	2
Sore	1/24 (4.2%)	1	1/24 (4.2%)	1
Stingy	1/24 (4.2%)	1	1/24 (4.2%)	1
Breathing problems and itch	0/24 (0%)	0	1/24 (4.2%)	1
Irritation and stingy	0/24 (0%)	0	1/24 (4.2%)	1
Social circumstances
Psychological	1/24 (4.2%)	1	1/24 (4.2%)	1
Sleepwalking, nausea and a feeling of fainting	1/24 (4.2%)	1	0/24 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.