Safety and efficacy of sFilm-FS, a novel biodegradable fibrin sealant, in Göttingen minipigs
| Autor: | Michal Steiner, Eran Cohen, Yotam Schwartz, Orgad Laub, Abraham Nyska, Yuval Ramot, Nati Ezov, Yossi Lavie |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Spleen Toxicology local tolerability Fibrin Pathology and Forensic Medicine Thrombin biodegradability medicine Adverse effect biodegradable materials Hemostatic Agent biology business.industry Sealant bleeding animal models Surgery medicine.anatomical_structure Hemostasis hemostasis biology.protein Original Article Complication business medicine.drug |
| Zdroj: | Journal of Toxicologic Pathology |
| ISSN: | 1881-915X 0914-9198 |
| Popis: | 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 co-polymeric 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 treatment-related 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 co-polymeric 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. |
| Databáze: | OpenAIRE |
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