Nanoparticles in Nasal Mucosa

Completed

• Conditions: Chronic Hypertrophic Rhinosinusitis; Chronic Polypous Rhinosinusitis
• Interventions: Procedure: Mucotomy

• Registration Number: NCT02270125
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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.

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-21
• Primary Completion: 2017-11
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients with chronic rhino sinusitis	Mucotomy	Group of adult patients indicated for mucotomy due to chronic hypertrophic rhinosinusitis, with or without polyposis
Stillborn children	Mucotomy	Control group of stillborn children whose nasal mucosa was not exposed to airborne particles

Primary Outcome Measures

Name	Time	Method
Detection and characterisation of nano particles	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.

Secondary Outcome Measures

Name	Time	Method
The presence of nano particles in the nasal mucosa obtained from stillborn children	36 months	Confirmation of the presence of nano particle in the nasal mucosa obtained from stillborn children (Yes/No).

Trial Locations

Locations (2)

Nanotechnology Centre, VSB-Technical University Ostrava; 🇨🇿 Ostrava, Czech Republic, Czechia

University Hospital Ostrava; 🇨🇿 Ostrava, Czech Republic, Czechia