Safety and efficacy of sFilm-FS, a novel biodegradable fibrin sealant, in Göttingen minipigs

Abstract

Bleeding during surgical procedures is a common complication. Therefore, hemostatic agents have been developed to control bleeding, and fibrin sealants have several benefits. sFilm-FS is a novel fibrin sealant that comprises a biodegradable copolymeric film embedded with human fibrinogen and thrombin. Herein, the safety and efficacy of sFilm-FS were compared using a liver and spleen puncture model of Göttingen minipigs with those of the standard hemostatic techniques (control animals) and EVARREST ® , a reference fibrin sealant. Hemostasis and reduced blood loss were more effectively achieved with sFilm-FS than with the standard techniques in the control animals and comparable to those achieved with EVARREST ® . No treatmentrelated adverse effects were observed in any of the groups. Histopathological evaluation indicated that sFilm-FS was slightly and moderately reactive at the liver puncture site and spleen, respectively, compared with the standard techniques in the control animals. These changes are expected degradation reactions of the copolymeric film and are not considered as adverse events. No treatment-related abnormalities were noted in the other evaluated organs. Additionally, no evidence of local or systemic thromboses was noted. These results support the use of sFilm-FS for hemostasis in humans.

Preclinical In-Vivo Safety of a Novel Thyrotropin-Releasing Hormone-Loaded Biodegradable Nanoparticles After Intranasal Administration in Rats and Primates

“…Therefore, the development of a new delivery device should include well-designed, regulated in vivo safety and toxicity studies. [37][38][39][40][41][42][43][44][45] Therefore, we performed two animal safety studies, one in rats another in cynomolgus monkeys, which historically have been used in safety evaluation studies and are recommended by appropriate regulatory agencies. Furthermore, it was essential to test whether the use of TRH in an intranasal route of administration can lead to any adverse events, since there is very little information on the in vivo safety of TRH when given intranasally.…”

Bioactive Hydrogels with Pro‐coagulation Effect for Hemostasis†

“…[ 101 ] After mixing these two precursors, the hemostatic materials obtained can come in a variety of forms like powder, [ 102 ] spray, [ 103 ] patch [ 104 ], or sealant. [ 105‐106 ] Since then, such kind of products were used widely in endoscopic surgery, biopsy perforation, renal resection, urologic injuries, liver surgery, etc . [ 87,89,92,107‐109 ] The catalysis activity maintaining of thrombin is the most important point for design of thrombin immobilized hydrogel.…”

Assessment of Bioprotect’s Biodegradable Balloon System as a Rectal Spacer in Radiotherapy: An Animal Study on Tissue Response and Biocompatibility

“…The utilization of biodegradable materials is progressively gaining traction across various medical disciplines [ 22 ]. Therefore, it is imperative that biodegradable materials undergo thorough evaluation through preclinical studies, emphasizing the importance of comprehending the anticipated clinical and pathological outcomes stemming from such investigations.…”

“…Therefore, it is imperative that biodegradable materials undergo thorough evaluation through preclinical studies, emphasizing the importance of comprehending the anticipated clinical and pathological outcomes stemming from such investigations. While there is a growing body of knowledge regarding the anticipated pathological findings associated with the use of biodegradable materials in suitable animal models [ 22 ], our understanding of biodegradable materials for rectal spacers remains relatively limited.…”