In vitro Comparison of Safety and Efficacy of Diluted Isotonic Seawater and Electrodialyzed Seawater for Nasal Hygiene

Barbara De Servi,1 Marisa Meloni,1 Amina Saaid,2 Josip Culig3 1In Vitro Research Laboratories, VitroScreen SrL, Milan, Italy; 2Department of R&D and Innovation, Laboratoire Fumouze, Levallois-Perret, France; 3Department of Pharmacology and Clinical Pharmacology, University of Applied Health...

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Autores principales:	De Servi B, Meloni M, Saaid A, Culig J
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2020
Materias:	nasal irrigation electrolyte balance homeostasis medical device nasal mucosa. Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/0c5f7c26710f480e91a450b38f785049
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spelling	oai:doaj.org-article:0c5f7c26710f480e91a450b38f7850492021-12-02T15:16:27ZIn vitro Comparison of Safety and Efficacy of Diluted Isotonic Seawater and Electrodialyzed Seawater for Nasal Hygiene1179-1470https://doaj.org/article/0c5f7c26710f480e91a450b38f7850492020-12-01T00:00:00Zhttps://www.dovepress.com/in-vitro-comparison-of-safety-and-efficacy-of-diluted-isotonic-seawate-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Barbara De Servi,1 Marisa Meloni,1 Amina Saaid,2 Josip Culig3 1In Vitro Research Laboratories, VitroScreen SrL, Milan, Italy; 2Department of R&D and Innovation, Laboratoire Fumouze, Levallois-Perret, France; 3Department of Pharmacology and Clinical Pharmacology, University of Applied Health Sciences, Zagreb, CroatiaCorrespondence: Barbara De ServiIn Vitro Research Laboratories, VitroScreen Srl, Via Mosè Bianchi 103, Milan 20149, ItalyTel +39-02-89077608Fax +39-02-45478817Email barbara.deservi@vitroscreen.comBackground: Nasal irrigation is often used for managing sinonasal conditions and maintaining nasal hygiene, which is critical to overall nasal health and to provide protection against airborne contaminants and pathogens. However, studies comparing efficacies of different solutions are needed.Purpose: This in vitro study evaluated the ionic balance of an isotonic diluted seawater solution (Stérimar Nasal Hygiene, SNH) and its safety and efficacy for regular nasal hygiene in comparison to electrodialyzed seawater (EDS).Materials and Methods: Ionic balance of SNH, EDS and pure seawater was measured by mass spectrometry and chromatography to be compared to the ionic balance of human plasma as reported in the literature. Safety was measured through cytotoxicity (lactate dehydrogenase release) and pro-inflammation (interleukin-8 secretion) assays using a 3D-reconstituted human nasal epithelium model. For efficacy, adenosine 5′-triphosphate (ATP) release assays, and histological (alcian blue) and immunohistochemical (aquaporin 3) stainings were performed on tissues under hypotonic challenge where saline solution was used as the negative control.Results: Compared to EDS, the ionic balance of SNH was more similar to human plasma and pure seawater. SNH reduced hypotonic stress-associated ATP release and maintained tissue morphology more effectively and lastingly compared to EDS. Both solutions were safe to use on nasal epithelium, as neither of them caused cytotoxicity or induced (pro-) inflammation.Conclusion: In comparison to EDS, this study confirms the safety and efficacy of SNH in maintaining good nasal hygiene consistent with its benefits reported in clinical trials.Keywords: nasal irrigation, electrolyte balance, homeostasis, medical device, nasal mucosaDe Servi BMeloni MSaaid ACulig JDove Medical Pressarticlenasal irrigationelectrolyte balancehomeostasismedical devicenasal mucosa.Medical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 13, Pp 391-398 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	nasal irrigation electrolyte balance homeostasis medical device nasal mucosa. Medical technology R855-855.5
spellingShingle	nasal irrigation electrolyte balance homeostasis medical device nasal mucosa. Medical technology R855-855.5 De Servi B Meloni M Saaid A Culig J In vitro Comparison of Safety and Efficacy of Diluted Isotonic Seawater and Electrodialyzed Seawater for Nasal Hygiene
description	Barbara De Servi,1 Marisa Meloni,1 Amina Saaid,2 Josip Culig3 1In Vitro Research Laboratories, VitroScreen SrL, Milan, Italy; 2Department of R&D and Innovation, Laboratoire Fumouze, Levallois-Perret, France; 3Department of Pharmacology and Clinical Pharmacology, University of Applied Health Sciences, Zagreb, CroatiaCorrespondence: Barbara De ServiIn Vitro Research Laboratories, VitroScreen Srl, Via Mosè Bianchi 103, Milan 20149, ItalyTel +39-02-89077608Fax +39-02-45478817Email barbara.deservi@vitroscreen.comBackground: Nasal irrigation is often used for managing sinonasal conditions and maintaining nasal hygiene, which is critical to overall nasal health and to provide protection against airborne contaminants and pathogens. However, studies comparing efficacies of different solutions are needed.Purpose: This in vitro study evaluated the ionic balance of an isotonic diluted seawater solution (Stérimar Nasal Hygiene, SNH) and its safety and efficacy for regular nasal hygiene in comparison to electrodialyzed seawater (EDS).Materials and Methods: Ionic balance of SNH, EDS and pure seawater was measured by mass spectrometry and chromatography to be compared to the ionic balance of human plasma as reported in the literature. Safety was measured through cytotoxicity (lactate dehydrogenase release) and pro-inflammation (interleukin-8 secretion) assays using a 3D-reconstituted human nasal epithelium model. For efficacy, adenosine 5′-triphosphate (ATP) release assays, and histological (alcian blue) and immunohistochemical (aquaporin 3) stainings were performed on tissues under hypotonic challenge where saline solution was used as the negative control.Results: Compared to EDS, the ionic balance of SNH was more similar to human plasma and pure seawater. SNH reduced hypotonic stress-associated ATP release and maintained tissue morphology more effectively and lastingly compared to EDS. Both solutions were safe to use on nasal epithelium, as neither of them caused cytotoxicity or induced (pro-) inflammation.Conclusion: In comparison to EDS, this study confirms the safety and efficacy of SNH in maintaining good nasal hygiene consistent with its benefits reported in clinical trials.Keywords: nasal irrigation, electrolyte balance, homeostasis, medical device, nasal mucosa
format	article
author	De Servi B Meloni M Saaid A Culig J
author_facet	De Servi B Meloni M Saaid A Culig J
author_sort	De Servi B
title	In vitro Comparison of Safety and Efficacy of Diluted Isotonic Seawater and Electrodialyzed Seawater for Nasal Hygiene
title_short	In vitro Comparison of Safety and Efficacy of Diluted Isotonic Seawater and Electrodialyzed Seawater for Nasal Hygiene
title_full	In vitro Comparison of Safety and Efficacy of Diluted Isotonic Seawater and Electrodialyzed Seawater for Nasal Hygiene
title_fullStr	In vitro Comparison of Safety and Efficacy of Diluted Isotonic Seawater and Electrodialyzed Seawater for Nasal Hygiene
title_full_unstemmed	In vitro Comparison of Safety and Efficacy of Diluted Isotonic Seawater and Electrodialyzed Seawater for Nasal Hygiene
title_sort	in vitro comparison of safety and efficacy of diluted isotonic seawater and electrodialyzed seawater for nasal hygiene
publisher	Dove Medical Press
publishDate	2020
url	https://doaj.org/article/0c5f7c26710f480e91a450b38f785049
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In vitro Comparison of Safety and Efficacy of Diluted Isotonic Seawater and Electrodialyzed Seawater for Nasal Hygiene

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