Nanoparticles in Nasal Mucosa

March 29, 2018 updated by: University Hospital Ostrava

The Role of Nanoparticles in Inflammatory Changes of the Nasal Mucosa

The aim of this prospective study is to evaluate presence and quantity of nano-sized particles and interindividual differences in their distribution and elemental composition in human nasal mucosa obtained by mucotomy in patients diagnosed with chronic hypertrophic rhinosinusitis and to compare the obtained results with control specimen obtained from stillborn children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Samples of nasal mucosa are obtained by mucotomy in general anesthaesia from adult patients with chronic hypertrophic rhinosinusitis. Each tissue sample is divided into 4 parts based on the distance from the nostrils and is dehydrated, thinly sliced and mounted on glass slides. Then the tissue is analyzed with scanning electron microscopy (SEM) and Raman microspectroscopy (RMS) to detect solid particles and characterize the morphology and compositions of the detected particles. A novel method of quantification of distribution of the particles has been designed and used to evaluate interindividual differences in distribution of the particles. History of employment is obtained from the patients and the data are compared with the findings in the tissue samples.

The data acquired from the group of adult patients are compared with the results obtained from a group of control specimen of nasal mucosa harvested from stillborn children. It is presumed that no nano particles will be present in the stillborn children specimen since the mucosa was not exposed to airborne particles.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Ostrava, Czech Republic, Czechia, 708 52
        • University Hospital Ostrava
      • Ostrava, Czech Republic, Czechia, 708 33
        • Nanotechnology Centre, VSB-Technical University Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with chronic hypertrophic rhinosinusitis, with or without polyposis Stillborn children

Description

Inclusion Criteria:

  • chronic hypertrophic rhihosinusitis without polyposis non responsive to conservative treatment for at least six months
  • chronic hypertrophic rhihosinusitis with polyposis non responsive to conservative treatment for at least six months
  • age between 19 and 64 years of age
  • signed informed consent of the patient
  • stillborn children born after 28th week of gestation

Exclusion Criteria:

- non-signing of the informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients with chronic rhino sinusitis
Group of adult patients indicated for mucotomy due to chronic hypertrophic rhinosinusitis, with or without polyposis
Procedure: Mucotomy
Surgical removal of hypertrophic mucosa of the inferior nasal turbinate by cold-steel instruments under endoscopic control, under general anaesthesia
Other Names:
  • turbinoplasty
Stillborn children
Control group of stillborn children whose nasal mucosa was not exposed to airborne particles
Procedure: Mucotomy
Surgical removal of hypertrophic mucosa of the inferior nasal turbinate by cold-steel instruments under endoscopic control, under general anaesthesia
Other Names:
  • turbinoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection and characterisation of nano particles
Time Frame: 36 months
Morphology characterization and elemental composition of the particles found in the nasal mucosa assessed with SEM (Quanta FEG 450, FEI) with X-ray microanalysis APOLLO X (EDAX) and SEM Philips XL 30 operating at 30 keV.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The presence of nano particles in the nasal mucosa obtained from stillborn children
Time Frame: 36 months
Confirmation of the presence of nano particle in the nasal mucosa obtained from stillborn children (Yes/No).
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Collaborators

VSB - Technical University of Ostrava

Investigators

  • Principal Investigator: Lenka Čábalová, MD, University Hospital Ostrava, Medical Faculty of the Ostrava University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 13, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-ENT-Nanoparticles
  • 2 RVO-FNOs/2013 (Other Grant/Funding Number: Ministry of Health of the Czech Republic)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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