The Safe-and-Sustainable-by-Design approach for alternative metal-free wound dressings in NABIHEAL

33 The Safe-and-Sustainable-by-Design approach for alternative metal-free wound dressings in NABIHEAL Julia Voglhuber-Höller1, Caitlin Ahern1, Johanna K. Scheper1 1BioNanoNet Forschungsgesellschaft mbH (BNN), Austria NABIHEAL Objective To facilitate the development of a safe(r) and more sustainable wound dressing by applying a Safe-and-Sustainable-by-Design approach in the early innovation phase. The NABIHEAL product will be a metal-free alternative for anti-microbial and wound-healing promoting wound dressings. [email protected] This project has received funding from the European Union’s Horizon Europe research and innovation program under grant agreement n°101092269. Chrounic wounds, Wound healing process and Standard-of-Care. Chronic wounds are characterized by persistence over more than 6 weeks despite active intervention and while showing no significant progression towards closure and healing. Such problematic wounds present in up to 2% of the population in industrialized countries [1, 2, 3]. This not only burdens individual patients but also strains public health systems, accounting for up to 4% of the total healthcare budget in Europe [2, 3]. Naturally, the gravest concern in regard to non-healing wounds is the high risk of infection with microbes. Current standard-of-care treatments rely heavily on silver-based agents, despite their limited efficacy, as proven by heterogenous outcomes of clinical trials, environmental impact, and costliness [4]. Figure 1: The four stages of the wound-healing process and corresponding time scale. (DOI:10.1007/s10787-023-01318-6) 12The Safe-and-Sustainable-by-Design applied in the nanomedical field. NABIHEAL understands sustainable development in ist three dimensions:safety, environmental and socio-economic. The methodology applied by the project advances scientific knowledge and innovation and upholds principles crucial for safe and sustainable biomedical research. By integrating SSbD principles throughout the whole innovation process, NABIHEAL contributes to the development for safer and more effective treatments while promoting environmental stewardship and socio-economic integrity in the biomedical sciences. Figure 2: Phases for the development of a nanomedical product and how to implement the SSbD approach. 3Methods & Approach in NABIHEAL. •Project-tailored SSbD concept development and implementation. •Tiered and hierarchical approach → following and aligned with the JRC SSbD framework [5] •Tailored questionnaires on (i) materials used/produced and (ii) for production and manufacturing processes developed and implemented at the start of the project and reviewed at different times during the project lifetime. Questionnaires builds on previous work from → Early4AdMa [6] & SUNSHINE [7] projects → Laboratory visits → Bilateral meetings with all actors involved in the project •Special focus on nano-safety issues and regulatory aspects to be addressed •Formulation of specific recommendations •Comparison to standard-of-care wound care materials 4Results of initial SSbD assessment from Step 1. Uncertainty for internal hazard was rather high for NABIHEAL components, but justified due the early project status. However, it should be noted that components are well characterized on a physicochemical level. Regarding human and environmental safety aspects NABIHEAL components were compared to the standard of care with the goal of ultimately surpassing them in scoring. C B A 5SSbD principle implementation among partners Implemented (blue), desired (white), deemed unfeasible (beige) or irrelevant (grey) by technical partners (n=12) at month 12. SSbD principle ICMAB NT BIO CH HCELL UM MyB UGR IMROH UEX AU IT ICMAB NT BIO CH HCELL UM MyB UGR IMROH UEX AU IT ICMAB NT BIO CH HCELL UM MyB UGR IMROH UEX AU IT ICMAB NT BIO CH HCELL UM MyB UGR IMROH UEX AU IT ICMAB NT BIO CH HCELL UM MyB UGR IMROH UEX AU IT ICMAB NT BIO CH HCELL UM MyB UGR IMROH UEX AU IT ICMAB NT BIO CH HCELL UM MyB UGR IMROH UEX AU IT ICMAB NT BIO CH HCELL UM MyB UGR IMROH UEX AU IT M12 SSbD1 Material efficiency SSbD2 Minimise the use of hazardous chemicals/materials SSbD3 Design for energy efficiency SSbD4 Use of renewable sources SSbD5 Prevent and avoid hazardous emissions SSbD6 Reduce exposure to hazardous substances SSbD7 Design for end-of-life SSbD8 Consider the whole life cycle Outcome and next steps This iterative approach monitors the progress of NABIHEAL and steers the project in a desirable direction in terms of safety and sustainability. By implementing these actions, we contribute to the development of innovative SSbD technologies for wound dressings, alleviating the burden of chronic wounds on affected patients as well as healthcare systems. Additionally to the benefits provided for NABIHEAL, this SSbD concept, one of the first cases in the medical sector, will provide valuable insights and learning outcomes for improved SSbD implementation in future projects and developments. References [1] Frykberg et al. Adv Wound Care (New Rochelle). 2015 /// [2] Phillips et al. Int Wound J. 2016 /// [3] Gottrup. The American Journal of Surgery. 2004 /// [4] Wilkins et al. Adv Skin Wound Care. 2013 /// [5] Caldeira et al. Publications Office of the European Union. 2022 /// [6] OECD. EHS, Environment Directorate. 2023 /// [7] Pizzol et al. Cleaner Environmental Systems. 2023 .