Safety and efficacy of sFilm-FS,a novel biodegradable fibrin sealant,in
Göttingen minipigs |
| |
Authors: | Yuval Ramot Michal Steiner Yossi Lavie Nati Ezov Orgad Laub Eran Cohen Yotam Schwartz Abraham Nyska |
| |
Affiliation: | 1.Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel;2.Department of Dermatology, Hadassah Medical Center, Jerusalem, 91120, Israel;3.Envigo CRS (Israel), Ness Ziona, 7403617, Israel;4.Sealantium Medical, Afek Industrial Area, P.O.B. 11817, Rosh Ha’Ayin, 4809239, Israel;5.Consultant in Toxicologic Pathology, Yehuda HaMaccabi 31, floor 5, Tel Aviv, 6200515, Israel;6.Tel Aviv University, 6200515, Israel |
| |
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 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. |
| |
Keywords: | biodegradability local tolerability biodegradable materials hemostasis bleeding animal models |
|
|