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

NCT02756351 | Completed Results

• 1 other identifier: CCNP-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Nosocomial Infections; Pneumonia, Ventilator-Associated

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

CytaCoat Nasal Prong

EXPERIMENTAL

The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.

Device: CytaCoat Nasal Prong

Reference Nasal Prong

ACTIVE COMPARATOR

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

Interventions

CytaCoat Nasal Prong DEVICE

CytaCoat Nasal Prong

Inspiration Healthcare Inspire nCPAP Nasal Prong DEVICE

Reference Nasal Prong

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CytaCoat AB: lead

Study Sites (1)

Neonatal, Karolinska University Hospital

Stockholm, Stockholm County, 171 76, Sweden

Location

MeSH Terms

Conditions

Cross Infection; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr Jacob Odeberg
• Organization: CytaCoat AB

jacob.odeberg@scilifelab.se

+46 (0) 70 2087571

Study Officials

• Baldvin Jonsson

  Neonatal, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 29, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 1, 2017
• Results First Posted: February 1, 2017

Record last verified: 2016-12

Locations

SE (1)