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Innovative medical device to prevent skin lesions caused by personal protective equipment due to Covid-19
Publication . Graça, A.; Marto, Joana Marques; Ribeiro, Helena Margarida Oliveira Marques; Loreau, Sara Sofia Caliço Raposo
The COVID-19 pandemic significantly increased the reliance on personal protective equipment (PPE) and rigorous hand sanitation practices. However, the prolonged use of PPE, particularly masks, caused skin issues such as acne, dermatitis, dryness, and rashes among healthcare professionals and frequent PPE users, due to sustained friction, pressure, and tension. These conditions are likely to impact both the physical comfort and the overall quality of life of PPE users. This study sought to address these challenges by developing gelatin-based hydrogel patches as a novel, sustainable, cost-effective solution to protect the skin of PPE users, with the potential to integrate active substances, thus offering additional therapeutic benefits. A gelatin-based hydrogel patch was designed using a Quality by Design (QbD) approach and design space tools, and optimized by incorporating excipients that improved gelation temperature, elasticity, and adhesiveness, characteristics that were confirmed through rheological analysis, Attenuated Total Reflectance Fourier-Transform Infrared spectroscopy (ATR-FTIR), and molecular docking. Tannic acid was added to further reinforce structural integrity and enable steam sterilization, enhancing the patch’s reusability and sustainability. In vitro and in vivo tests were conducted to validate the physical properties and protective efficacy of the hydrogel patches. In vitro assays assessed cytotoxicity, biocompatibility and antioxidant activity, while in vivo biometric measurements evaluated skin temperature, sebum level, hydration, transdermal water loss (TEWL), and redness in human volunteers using FFP2 masks. As an innovative approach, active ingredients - metronidazole (1% w/w) and salicylic acid (2% w/w) - were added separately into the gelatin/tannic acid hydrogel formulation to create dual-function patches for skin barrier protection and targeted treatment of conditions like rosacea and maskne. The hydrogel patches were evaluated for gelation temperature, burst strength, extensibility, adhesivity, and tribological behavior, to study the impact of the active ingredients on the patches’ mechanical properties. Additionally, in vitro release and permeation studies were conducted to assess the active ingredients’ release profiles and skin permeation efficiencies. Finally, extrusion-based 3D printing technology was employed to customize hydrogel patches with different infill patterns, tailored for specific structural and release requirements. The gelatin-based hydrogel patch exhibited enhanced physical properties, including higher gelation temperature, steam sterilization capacity, enhanced burst strength, and increased elasticity, attributed to the addition of tannic acid. Rheological and texture analyses, supported by molecular docking studies, confirmed strong interactions between gelatin and the excipients, particularly tannic acid, which contributed to the patch's enhanced mechanical properties and adhesiveness. Tribology studies revealed consistent friction levels across different temperatures and skin types, indicating reliable usability. In vitro studies using the HaCaT cell line confirmed the hydrogel patch’s suitability for topical application, showing biocompatibility, no cytotoxic effects, and antioxidant properties, highlighting its potential for safe use. In vivo biometric analysis indicated that when the patch was used under FFP2 masks, it significantly increased skin hydration and reduced facial redness, without affecting baseline facial temperature or TEWL, thus reinforcing the skin barrier without compromising comfort. Positive consumer feedback on patch application further supported its acceptability in real-world conditions. In vitro drug release studies showed an initial burst followed by sustained release of both metronidazole and salicylic acid, confirming a controlled release mechanism for all tested formulations. In vitro permeation studies revealed that metronidazole exhibited limited skin penetration, suggesting minimal systemic absorption, whereas salicylic acid successfully penetrated the epidermal barrier, despite low retention. These findings suggest that the patches hold significant potential for effectively treating skin lesions. The use of extrusion-based 3D printing allowed the customization of gelatin/tannic acid hydrogel patches containing active ingredients. Different infill patterns affected both tensile strength, drug release rates and permeation profile, with grid patterns yielding the strongest structures and most controlled release, further underscoring the adaptability of this approach for personalized skin care solutions. This study introduces an innovative, sustainable, and effective solution for skin protection: a gelatin-based hydrogel patch reinforced with tannic acid, designed to address PPE-induced skin lesions. The addition of tannic acid enhanced structural integrity and enabled sterilization, which improved the patch's reusability and sustainability. The patch’s protective efficacy, confirmed by in vitro and in vivo assessments, highlights its potential for widespread use, particularly among healthcare professionals. Additionally, the personalized 3D printed hydrogel patches containing active ingredients offer a targeted approach for managing specific skin conditions like rosacea and maskne. By preventing common PPE-related skin issues, these patches offer a practical, adaptable, and sustainable approach to maintaining skin health and comfort during prolonged PPE use. The patch’s optimized design, performance, and adaptability underscore its significance as a sustainable and effective skincare solution in clinical and pandemic contexts.
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Fundação para a Ciência e a Tecnologia
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2020.10138.BD