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Nanoparticles in Nasal Mucosa

The Role of Nanoparticles in Inflammatory Changes of the Nasal Mucosa

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02270125
Enrollment
40
Registered
2014-10-21
Start date
2013-09-30
Completion date
2017-12-31
Last updated
2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hypertrophic Rhinosinusitis, Chronic Polypous Rhinosinusitis

Keywords

nasal mucosa, chronic hypertrophic rhinosinusitis, mucotomy, nanoparticles, scanning electron microscopy, Raman microspectroscopy, nasal polyposis

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.

Interventions

PROCEDUREMucotomy

Surgical removal of hypertrophic mucosa of the inferior nasal turbinate by cold-steel instruments under endoscopic control, under general anaesthesia

Sponsors

VSB - Technical University of Ostrava
CollaboratorUNKNOWN
University Hospital Ostrava
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Detection and characterisation of nano particles36 monthsMorphology 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

MeasureTime frameDescription
The presence of nano particles in the nasal mucosa obtained from stillborn children36 monthsConfirmation of the presence of nano particle in the nasal mucosa obtained from stillborn children (Yes/No).

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026