Giovanni Damiani1,2, Laura C Gironi3, Alessia Pacifico4, Antonio Cristaudo4, Piergiorgio Malagoli5, Francesca Allocco6, Nicola L Bragazzi7, Dennis M Linder8, Pierachille Santus9, Alessandra Buja10, Paola Savoia11, Paolo Dm Pigatto12,13. 1. Department of Clinical Dermatology, IRCCS Galeazzi Orthopedic Institute, Milan, Italy - dr.giovanni.damiani@gmail.com. 2. Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy - dr.giovanni.damiani@gmail.com. 3. Maggiore della Carità University Hospital, Novara, Italy. 4. Department of Clinical Dermatology, IRCCS S. Gallicano Dermatological Institute, Rome, Italy. 5. Unit of Dermatology, Hospital of San Donato Milanese, San Donato Milanese, Milan, Italy. 6. Law Firm Avv. Allocco, Gardone Val Trompia, Brescia, Italy. 7. Department of Mathematics and Statistics, Laboratory for Industrial and Applied Mathematics (LIAM), York University, Toronto, ON, Canada. 8. Department of Dermatology, University Hospital, Padua, Italy. 9. Respiratory Unit, Department of Biomedical And Clinical Sciences (DIBIC), University of Milan, Luigi Sacco University Hospital, ASST Fatebenefratelli-Sacco, Milan, Italy. 10. Department of Cardiological, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy. 11. Department of Health Sciences, University of Eastern Piedmont, Novara, Italy. 12. Department of Clinical Dermatology, IRCCS Galeazzi Orthopedic Institute, Milan, Italy. 13. Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.
Abstract
BACKGROUND: During the recent COVID-19 outbreak, masks became mandatory and shortages frequent, therefore the prevalence of non-CE (European Conformity Mark) approved masks increased in the general population. We aimed to quantify the prevalence of mask-related cutaneous side effects and the differences between CE and non-CE approved masks. METHODS: In this multicenter prospective observational study conducted from March 20, 2020 to May 12, 2020(during and after quarantine), patients attending emergency departments for a dermatological consult were clinically assessed and their masks were inspected to detect CE marks and UNI (Italian National Unification Entity) norms. Patients with history of facial dermatoses or under current treatment for facial dermatoses were excluded. RESULTS: We enrolled 412 patients (318 during quarantine and 94 after quarantine). CE-approved masks were observed 52.8% vs. 24.5%, whilst subsets of non-CE approved masks were 9.7% vs. 14.9% (Personal protective equipment (PPE)-masks), 16.4% vs. 12.8% (surgical masks [SM]), and 21.1% vs. 47.9%(non-PPE) and (non-SM masks), respectively during and after quarantine. Remarkably, non-CE-approved masks resulted in patients displaying a statistically significant higher incidence of facial dermatoses and irritant contact dermatitis compared to CE-approved masks, and these differences were mainly driven by non-PPE non-SM masks. Comparing quarantine and after quarantine periods, no statistically significant differences were found for CE-approved masks, whilst differences were detected in non-CE-approved masks regarding incidence of facial dermatoses (P<0.0001)and irritant contact dermatitis (P=0.0041). CONCLUSIONS: Masks are essential to prevent COVID-19 but at the same time higher awareness regarding mask specifications should be promoted in the general population. Non-PPE and non-SM masks should undergo more rigorous testing to prevent the occurrence of cutaneous side effects and future patients' lawsuit damages.
BACKGROUND: During the recent COVID-19 outbreak, masks became mandatory and shortages frequent, therefore the prevalence of non-CE (European Conformity Mark) approved masks increased in the general population. We aimed to quantify the prevalence of mask-related cutaneous side effects and the differences between CE and non-CE approved masks. METHODS: In this multicenter prospective observational study conducted from March 20, 2020 to May 12, 2020(during and after quarantine), patients attending emergency departments for a dermatological consult were clinically assessed and their masks were inspected to detect CE marks and UNI (Italian National Unification Entity) norms. Patients with history of facial dermatoses or under current treatment for facial dermatoses were excluded. RESULTS: We enrolled 412 patients (318 during quarantine and 94 after quarantine). CE-approved masks were observed 52.8% vs. 24.5%, whilst subsets of non-CE approved masks were 9.7% vs. 14.9% (Personal protective equipment (PPE)-masks), 16.4% vs. 12.8% (surgical masks [SM]), and 21.1% vs. 47.9%(non-PPE) and (non-SM masks), respectively during and after quarantine. Remarkably, non-CE-approved masks resulted in patients displaying a statistically significant higher incidence of facial dermatoses and irritant contact dermatitis compared to CE-approved masks, and these differences were mainly driven by non-PPE non-SM masks. Comparing quarantine and after quarantine periods, no statistically significant differences were found for CE-approved masks, whilst differences were detected in non-CE-approved masks regarding incidence of facial dermatoses (P<0.0001)and irritant contact dermatitis (P=0.0041). CONCLUSIONS: Masks are essential to prevent COVID-19 but at the same time higher awareness regarding mask specifications should be promoted in the general population. Non-PPE and non-SM masks should undergo more rigorous testing to prevent the occurrence of cutaneous side effects and future patients' lawsuit damages.