Department of Clinical Dermatology, IRCCS Galeazzi Orthopedic Institute, Milan, Italy -
Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy -
Ital J Dermatol Venerol. 2021 Apr;156(2):220-225. doi: 10.23736/S2784-8671.21.06895-4.
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.
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.
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).
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.
在最近的 COVID-19 疫情期间，口罩成为必需品，且经常出现短缺，因此普通人群中使用未经 CE（欧洲符合性标记）认证的口罩的情况越来越多。我们旨在量化与口罩相关的皮肤副作用的发生率，以及 CE 和非 CE 认证口罩之间的差异。
在这项于 2020 年 3 月 20 日至 5 月 12 日（隔离期间和之后）进行的多中心前瞻性观察研究中，因皮肤科就诊而前往急诊室的患者接受了临床评估，并检查了他们的口罩，以检测 CE 标志和 UNI（意大利国家统一机构）规范。患有面部皮肤病病史或正在接受面部皮肤病治疗的患者被排除在外。
我们共纳入了 412 名患者（隔离期间 318 名，隔离后 94 名）。观察到 CE 认证口罩的比例为 52.8%，而非 CE 认证口罩的比例为 24.5%，而非 CE 认证口罩中，个人防护设备 (PPE) 口罩、手术口罩 (SM) 和非 PPE 非 SM 口罩的比例分别为 9.7%、16.4%和 21.1%，非 SM 口罩的比例为 47.9%。值得注意的是，与 CE 认证口罩相比，非 CE 认证口罩会导致患者面部皮肤病和刺激性接触性皮炎的发生率显著更高，这些差异主要是由非 PPE 非 SM 口罩引起的。比较隔离期间和隔离后，CE 认证口罩的发生率没有统计学上的显著差异，而非 CE 认证口罩的发生率有统计学差异，包括面部皮肤病（P<0.0001）和刺激性接触性皮炎（P=0.0041）。
口罩对于预防 COVID-19 至关重要，但同时应在普通人群中提高对口罩规格的认识。非 PPE 和非 SM 口罩应进行更严格的测试，以防止皮肤副作用和未来患者的诉讼损害的发生。
