key: cord-1018694-2ypbpqtf authors: Hua, Wei; Zuo, Ying; Wan, Ruoyu; Xiong, Lidan; Tnag, Jie; Zou, Lin; Shu, Xiaohong; Li, Li title: Short‐term Skin Reactions Following Use of N95 Respirators and Medical Masks date: 2020-05-13 journal: Contact Dermatitis DOI: 10.1111/cod.13601 sha: dff258238ea73df01556da00a99a5f8e75e121da doc_id: 1018694 cord_uid: 2ypbpqtf nan The rapid spread of SARS-CoV-2, a novel coronavirus that emerged in late 2019, and the resulting COVID-19 disease has been labeled a Public Health Emergency of International Concern by the World Health Organization. 1 Globally, millions of confirmed cases of COVID-19 have been reported. Understanding of the transmission risk is incomplete. Person-to-person spread is thought to occur mainly via respiratory droplets and contact. 2 Healthcare workers who care for COVID-19 patients are at great risk of contracting the disease and, therefore, it is necessary for them to wear the personal protective equipment. Respiratory protective equipment (RPE) such as respirators and medical masks is often worn for hours at a time. Even though the usefulness of wearing masks in the context of the covid-19 pandemic is still largely unknown, it is more and more common to see people wearing masks in public recently, particularly in Asia. 3, 4 With respect to the use of RPE, dermatologists at our hospital have observed isolated cases of adverse skin reactions. Skin reactions such as contact dermatitis, acne, facial itch and rash from RPE use are reported. 5, 6, 7, 8 However, information on various skin reactions to the use of RPE is insufficient. Our aim was to analyze the short-term effects of N95 respirators and medical masks on skin physiological properties and to report on adverse skin reactions caused by the equipment. This article is protected by copyright. All rights reserved. This study used a repeated-measures crossover random design. Healthy participants without any history of skin diseases or skin changes on test sites were included in the trial. Exclusion criteria were use of corticosteroids and immunomodulators a month before the inclusion and during the trial, nonadherence to the trial protocol, pregnancy, lactation and excessive and deliberate exposure to the solar ultraviolet radiation. The study protocol was approved by the Institutional Ethics Committee of West China Hospital, Sichuan University ( No.2020-225 ) and all participants gave written informed consent before entering the trial. This trial was run from February to April 2020 and was registered at ChiCTR as ChiCTR2000031977. After being evaluated for eligibility, all subjects were followed for two test days (intersession interval more than one day). Participants were randomly assigned to wear either an N95 respirator (1860 from 3M Corporation, St Paul, Minnesota) or a medical mask (surgical mask from Winner Medical, Huanggang, Hubei, China) for the first test day. During the second test day, participants were crossed over to the other intervention. Participants were initially educated regarding medical masks and N95 respirators according to the guidance from 3M and passed the Seal-check when wearing N95 respirators. 9,10 They gently washed their faces with water and were acclimatized to an indoor environment without RPE for This article is protected by copyright. All rights reserved. 60 minutes. After their baseline levels were measured, they wore the RPE for 2 hours, after which measurements were taken again. After a 1-hour -interval off RPE, they wore the masks for another 4 hours. Measurements were taken immediately after the masks were taken off and then after two intervals of 30 minutes each (eFigure 1 in the Appendices). The measurements were completed within 10 minutes at each time point. Additionally, adverse reactions were assessed clinically and via interview by a trained professional, blinded to the type of mask which had been used. Skin symptoms to RPE wearing, including redness or erythema, facial indentation, itch, pain or prickling, burning, were recorded. Furthermore, reactions of respiratory tract and eyes, like itchy nose, sneezing, running nose, stuffy nose, itchy throat, cough, chest tightness and shortness of breath, itchy eyes and watering eyes were also recorded. Perceived discomfort and incompliance were measured using a modified Comfort Scale, 11 consisting of three Likert scales ranging from 1 to 5 points. Skin parameters were assessed using noninvasive bioengineering measurements. Facial skin was divided into RPE-covered area and RPE-uncovered area, both of which were measured at the same time point. The "Tewameter" TM300, "Corneometer" CM825, "Mexameter" MX18, "Skin-pH-Meter" PH 905, "Sebumeter" SM 815 (Courage+Khazaka, Cologne, Germany) were used to determine transepidermal water loss (TEWL), skin hydration, erythema, pH and sebum secretion. All measurements were taken in accordance with guidelines on designated areas of the face (eFigure 2 in This article is protected by copyright. All rights reserved. the Appendices). 12, 13, 14, 15 Clinical pictures were taken with VISIA (Canfield Scientific, Fairfield, New Jersey). The room for measurements was kept at a constant temperature (20-22 °C) and relative humidity range (40-60%). The SPSS 20.0 statistical analysis package (SPSS, Chicago, Illinois) was used to evaluate the significance level. A P-value of < .05 was considered statistically significant. The skin physiological properties of RPE wearing by time and group were analyzed using repeated measures ANOVA (RM-ANOVA) with post hoc Bonferroni correction. The comparison of skin symptoms related to the N95 respirators and medical masks were compared by Fisher's exact test. A paired t-test was carried out to determine whether there was a difference between the discomfort and incompliance scores with the two kinds of RPE. Twenty Chinese participants enrolled in and completed the study. The mean (SD) age was 34.3 (11.5) years. Two of the participants (10%) were male. This article is protected by copyright. All rights reserved. Clinical pictures of one subject are shown in Figure 2 . All subjects reported adverse skin reactions with the use of the N95 respirator, which were significantly greater than reactions caused by the medical mask (10 subjects, 50%, P＜ .001). There was no significant difference between the number of subjects who reported respiratory tract symptoms with the two different kinds of RPE. One and two subjects had eye symptoms with the medical mask and N95 respirator, respectively (Table 1 ). Discomfort and incompliance levels of wearing N95 respirators compared to medical masks were assessed in three aspects using a five-point Likert scale. Scores were aggregated to generate a 'discomfort and incompliance score' with a range of 3 to 15 ( Table 2 ). The mean score of N95 This article is protected by copyright. All rights reserved. In the context of the COVID-19 pandemic, the issue of wearing masks is put in the focus of debate. Increasing numbers of agencies and governments, including the US Centers for Diseases Control and Prevention, are advocating that the general population wears masks, 16 but others, such as the World Health Organization and Public Health England are not. 17 Much remains unknown about the usefulness of population level mask wearing, while the use of masks in healthcare settings is clearly essential to protect frontline workers. 18 We observed that the level of skin hydration, TEWL, erythema, pH and sebum secretion increased after participants donned the masks and respirators; these values subsequently decreased after RPEdoffing. Even though no statistically differences in the values have been found between the two kinds of mask-covered skin, it takes more time for the N95-covered skin to return to initial levels of skin hydration and erythema, and to decrease to TEWL levels to those of uncovered skin. These skin properties can be influenced by a number of endogenous and external factors, such as anatomic, site, age, gender, circadian rhythms, temperature and humidity. 19, 20 Because of expiration and an occlusion effect on the masked skin, the local environment has been changed. The temperature and humidity could be increased, comparable with diapered skin to some extent, except for the presence of fecal and urinary waste. The increased temperature, excessive moisture and friction all contribute to the local disruption of the skin barrier function. 21 This article is protected by copyright. All rights reserved. Our results show that skin reactions to the RPE are characterized by a compromised skin barrier function as indicated by increased TEWL and pH. Measuring TEWL is a non-invasive method that allows for the evaluation of the skin barrier function. However, we determined that over-moisturized skin causes sweat and that areas with increased amount of sweat resulted in a high TEWL. The normal acidic pH of the stratum corneum has an important role in the formation and maintenance of the permeability barrier and in antimicrobial defense. Skin pH was significantly more alkaline on masked areas, which consist with previous findings of changes on diapered skin. 21 Erythema occurs as a result of cutaneous blood vessel dilation and increased blood flow to the skin. Although transient facial erythema in this study could be observed as a normal, neurologically mediated response to heat or pressure exposure, inflammation can lead to longer-lasting erythema. It was previously shown in a study imitating the occlusive environment of diapered skin that prolonged occlusion in the presence of digestive enzymes induces skin erythema. 22 Cunliff et al 23 found that sebum secretion becomes elevated by 10% as the local temperature increases by 1 °C. In this study, it is interesting to note that the sebum level increased not only on the masked skin, but also on the uncovered skin. Sebum secretion changed with the circadian rhythm, 24 which might provide an alternative explanation for the result. Previously N95 and surgical masks have been documented to contain formaldehyde and other preservatives, which might induce contact dermatitis. 6, 7 Friction, warmth, and moisture from respiration may enhance symptoms. 8 The overall prevalence of skin damage caused by enhanced This article is protected by copyright. All rights reserved. infection-prevention measures was 97.0% (526 of 542) among first-line health care workers. 25 A survey in Singapore 5 reported 109 (35.5%) of the 307 staff who used N95 respirators regularly reported adverse skin reactions, which included acne (59.6%), facial itch (51.4%), and rash (35.8%), which is consistent with our findings on the changes in skin barriers function and sebum secretion. In this study, the most frequent adverse reactions of the respirators and masks were pressure-related. Symptoms suggesting allergic or irritant reactions (e.g. itch, redness and rashes) were also common. Although N95 respirators appeared to have a protective advantage over medical masks in laboratory settings, meta-analysis showed that there were insufficient data to determine definitively whether N95 respirators are superior to surgical masks in protecting health care workers against transmissible acute respiratory infections in clinical settings. 26, 27 N95 masks were associated with more reactions than medical masks, 28 which might be related to the higher air impermeability and more pronounced local pressure compared to medical masks. Our survey revealed a higher incompliance concerning respirator use owing to discomfort, which could enable transmission of pathogens. Mask and respirator interventions were generally reported to be cost saving or cost-effective when compared to no intervention or other control measures; however, the evaluations had important limitations. 29 Further, it has been reported that the incremental cost to prevent a clinical respiratory illness case with continuous use of N95 respirators when compared to medical masks ranged from US $490-$1230. 30 However, cost of skin problems related to masks and respirators have not been take into consideration yet. This article is protected by copyright. All rights reserved. Limitations of this study include the small sample size and short period. To ensure the respirators were donned correctly, it is suggested to do fit testing before use. As we were not equipped with material for testing fit, we trained the subjects and conducted a seal-check before the test to make sure the RPE were used appropriately as much as possible. This study demonstrates that skin hydration, TEWL, erythema, pH and sebum secretion increased after donning masks and respirators. There was no significant difference between the physiological values on the N95-covered and medical mask-covered areas at any time point. However, N95 masks were associated with more skin reactions than medical masks and with higher discomfort and incompliance scores. This article is protected by copyright. All rights reserved. b. Score refers to 'I want to touch or adjust the mask or respirator while wearing.' 1= you never want to touch or adjust the mask to 5= you always want to touch or adjust the mask; c. Score refers to 'I want to take off the mask or respirator.' 1= you never want to take off the mask to 5= you always want to take off the mask. This article is protected by copyright. All rights reserved. World Health Organization. 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