Nanoparticles in Nasal Mucosa

Chronic Polypous Rhinosinusitis Clinical Trial

Official title:

The Role of Nanoparticles in Inflammatory Changes of the Nasal Mucosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270125
• Other study ID #: FNO-ENT-Nanoparticles
• Secondary ID: 2 RVO-FNOs/2013
• Status: Completed
• First received: October 13, 2014
• Last updated: March 29, 2018
• Start date: September 2013
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hypertrophic Rhinosinusitis
• Chronic Polypous Rhinosinusitis
• Hypertrophy
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
Czechia	Nanotechnology Centre, VSB-Technical University Ostrava	Ostrava	Czech Republic
Czechia	University Hospital Ostrava	Ostrava	Czech Republic

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Ostrava	VSB - Technical University of Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

Dvorackova J, Bielnikova H, Kukutschova J, Peikertova P, Filip P, Zelenik K, Kominek P, Uvirova M, Pradna J, Cermakova Z, Dvoracek I. Detection of nano- and micro-sized particles in routine biopsy material - pilot study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015 Mar;159(1):87-92. doi: 10.5507/bp.2012.104. Epub 2012 Dec 10. — View Citation

Oberdörster G, Oberdörster E, Oberdörster J. Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles. Environ Health Perspect. 2005 Jul;113(7):823-39. Review. Erratum in: Environ Health Perspect. 2010 Sep;118(9):A380. — View Citation

Zeleník K, Kukutschová J, Dvorácková J, Bielniková H, Peikertová P, Cábalová L, Komínek P. Possible role of nano-sized particles in chronic tonsillitis and tonsillar carcinoma: a pilot study. Eur Arch Otorhinolaryngol. 2013 Feb;270(2):705-9. doi: 10.1007/s00405-012-2069-5. Epub 2012 Jun 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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