Background : Head and Neck cancers are common, 4th ranking in terms of incidence. Total (pharyngo) laryngectomy (T(P)L) is a common surgery for the treatment of pharyngo-laryngeal cancers and results in the definitive separation of the respiratory and digestive (neo-pharyngeal) tracts. The main issue with this surgery is salivary fistula (SF) (incidence of 20 to 65%), causing leaks of saliva between the sutures of the neo-pharynx. One of the main risk factors is a history of irradiation. Saliva, by flowing into the neck, causes high morbidity i.e. increased length of hospitalization, surgical revision, risk of vascular rupture and death i.e. incidence of carotid blowout syndrome around 3%. There is no current solution to reduce the incidence of SF. Objectives and means: The BIOFISS project aims to develop an innovative biomaterial (MD) in the form of a double-layer film based on biopolymers, alginate and chitosan, for the prevention of SF. The project brings together a suitable consortium with a hospital specialized in oncology (IUCT-O), 2 academic research laboratories specialized in biomaterials (CIRIMAT and INSERM UMR 1121) and 2 industrial partners (RESCOLL and Brothier) including a MD manufacturer specialized in alginate, one of the constituents of the MD. This project is based on preliminary results concerning the design of alginate-based biomaterials (CIRIMAT laboratory). The 4 main objectives of the BIOFISS project are 1) development of MD to obtain the physico-chemical and biological properties suitable for the prevention of SF; 2) characterization of its in vitro properties (biocompatibility, mechanical properties, bioadhesion, degradation time); 3) in vivo evaluation; 4) transfer and valorization Materials and Methods: This project is planned over a total of 48 months and is divided into 5 scientific axes (WP): 1. WP0: project coordination (IUCT-O/all partners) 2. WP1: Optimization of MD for SF prevention with 2 tasks: 1) development of the impermeable layer; 2) development of the absorbent layer. This axis will be coordinated by CIRIMAT using the technologies of RESCOLL and INSERM UMR 1121. Brothier will provide the alginate and will contribute its knowledge on these materials. 3. WP2: in vitro characterization of the physicochemical properties of MD; this axis will be coordinated by INSERM 1121 in collaboration with CIRIMAT. 3 tasks will be carried out: 1) evaluation of biocompatibility; 2) evaluation of healing properties; 3) evaluation of antimicrobial properties. 4. WP 3: in vivo evaluation (IUCT-O) with 4 tasks: 1) evaluation of biocompatibility and bioadhesion in a rat pharyngotomy model; 2) development of an irradiated mini-pig model; 3) development of a laryngectomized mini-pig model; 4) evaluation of the efficacy of MD on laryngectomized pigs with or without irradiation with a control group. 5. WP4: Evaluation of results, transfer and valorisation of technologies (Brothier laboratory) Expected results: In accordance with the ANR Call for Proposals, the goal of our project is to design an innovative MD aimed to reduce the rate of SF in T(P)L patients undergoing T(P)L surgery. Based on a strong consortium, all data collected during the project will provide evidence of the efficacy and safety of the new MD for the initiation of a clinical trial in the prevention of the risk of SF after neck surgery. The field of use of the biomaterial could be wider than the T(P)L, i.e. useful for many cervico-facial surgeries (cancer or not) or even in digestive surgery. BIOFISS will make it possible to perpetuate the collaboration between industrial partners for the commercialization of this new biomaterial. A new production line, which will require the recruitment of qualified personnel, will be created within Brothier for the manufacture of this new MD.