Development of smart clothing to prevent pressure injuries in bedridden persons and/or with severely impaired mobility: 4NoPressure research protocol

Data Availability Statement: The data presented in this study are available upon request from the corresponding author. Data will not be made publicly available due to the patenting process of the device under development. Pressure injuries (PIs) are a major public health problem and can be used as quality-of-care indicators. An incipient development in the field of medical devices takes the form of Smart Health Textiles, which can possess innovative properties such as thermoregulation, sensing, and antibacterial control. This protocol aims to describe the process for the development of a new type of smart clothing for individuals with reduced mobility and/or who are bedridden in order to prevent PIs. This paper’s main purpose is to present the eight phases of the project, each consisting of tasks in specific phases: (i) product and process requirements and specifications; (ii and iii) study of the fibrous structure technology, textiles, and design; (iv and v) investigation of the sensor technology with respect to pressure, temperature, humidity, and bioactive properties; (vi and vii) production layout and adaptations in the manufacturing process; (viii) clinical trial. This project will introduce a new structural system and design for smart clothing to prevent PIs. New materials and architectures will be studied that provide better pressure relief, thermo-physiological control of the cutaneous microclimate, and personalisation of care. The 4NoPressure project was co-financed by the Operational Program for Competitiveness and Internationalisation (COMPETE 2020) under the PORTUGAL 2020 Partnership Agreement, with support from the European Regional Development Fund (ERDF), reference number POCI-01-0247-FEDER-039869.