Nanoparticles in Nasal Mucosa

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Role of Nanoparticles in Inflammatory Changes of the Nasal Mucosa

Conditions
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Chronic Hypertrophic Rhinosinusitis, Chronic Polypous Rhinosinusitis

Intervention / Treatment
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* Procedure: Mucotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection and characterisation of nano particles | 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 | Confirmation of the presence of nano particle in the nasal mucosa obtained from stillborn children (Yes/No). | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal mucosa, chronic hypertrophic rhinosinusitis, mucotomy, nanoparticles, scanning electron microscopy, Raman microspectroscopy, nasal polyposis