Nanoparticles in Nasal Mucosa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Chronic Hypertrophic Rhinosinusitis Chronic Polypous Rhinosinusitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients with chronic rhino sinusitis

Group of adult patients indicated for mucotomy due to chronic hypertrophic rhinosinusitis, with or without polyposis

Mucotomy

Intervention Type PROCEDURE

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

Stillborn children

Control group of stillborn children whose nasal mucosa was not exposed to airborne particles

Mucotomy

Intervention Type PROCEDURE

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

Interventions

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Mucotomy

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

Intervention Type PROCEDURE

Other Intervention Names

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turbinoplasty

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