Background Wound haemostasis is an important part of clinical treatments, especially treatments for patients with avulsion injury, destructive injury and large-scale soft tissue injury. Therefore, developing fast and effective haemostatic materials is critical. This study aimed to design a novel and efficient silk fibroin–gelatine composite haemostatic sponge loaded with thrombin (SFG@TB) to assist in wound haemostasis. Methods The SFG@TB composite haemostatic sponge was formed with gelatine, silk fibroin and thrombin through a freeze-drying technique. First, the material characteristics of SFG@TB were measured, including the elastic modulus, swelling rate and porosity. Second, in vitro cell coculture experiments, in vivo embedding experiments and haemolytic analyses were performed to evaluate the biocompatibility of SFG@TB. Then, coagulation experiments and femoral artery and liver bleeding models were used to evaluate the haemostatic performance of SFG@TB. Finally, the ability of SFG@TB to promote tissue healing was evaluated through experiments with Sprague–Dawley rat models of injury. Results Compared with gelatine sponges, SFG@TB exhibited outstanding mechanical properties and water absorption properties. In addition, the excellent biosafety of the composite haemostatic sponge was confirmed by cell experiments, subcutaneous embedding experiments and haemolytic analysis. Based on the in vitro coagulation test results, SFG@TB exhibited greater adhesion of red blood cells and platelets and a shorter dynamic coagulation time. Compared to the use of silk fibroin–gelatine composite haemostatic sponges or gelatine sponges, the introduction of thrombin resulted in a shorter haemostasis time and a smaller bleeding volume, as revealed by in vivo coagulation tests. The experiments with Sprague–Dawley rat models of injury indicated that SFG@TB accelerated the wound healing process and reduced scar width, which was accompanied by thicker granulation tissue. Conclusions Overall, the SFG@TB composite haemostatic sponge, which exhibits outstanding mechanical properties, good haemostatic performance and high biosafety, promoted wound haemostasis and tissue repair. Therefore, the SFG@TB composite haemostatic sponge could be a promising material for wound haemostasis.

中文翻译：

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载有凝血酶的丝素蛋白-明胶止血海绵，用于伤口止血和组织再生


背景 伤口止血是临床治疗的重要组成部分，尤其是撕脱伤、破坏性损伤和大面积软组织损伤患者的治疗。因此，开发快速有效的止血材料至关重要。本研究旨在设计一种新型高效的蚕丝素蛋白-明胶复合止血海绵，负载凝血酶 （SFG@TB） 以辅助伤口止血。方法 以明胶、丝素蛋白和凝血酶为原料，采用冷冻干燥技术制备SFG@TB复合止血海绵。首先，测量SFG@TB的材料特性，包括弹性模量、溶胀速率和孔隙率;其次，进行体外细胞共培养实验、体内包埋实验和溶血分析，评价SFG@TB的生物相容性。然后，采用凝血实验和股动脉和肝脏出血模型评价SFG@TB的止血性能。最后，通过使用 Sprague-Dawley 大鼠损伤模型的实验评估 SFG@TB 促进组织愈合的能力。结果 与明胶海绵相比，SFG@TB表现出优异的力学性能和吸水性能。此外，通过细胞实验、皮下包埋实验和溶血分析证实了复合止血海绵优异的生物安全性。根据体外凝血试验结果，SFG@TB表现出更大的红细胞和血小板粘附和更短的动态凝血时间。与使用丝素蛋白-明胶复合止血海绵或明胶海绵相比，凝血酶的引入导致止血时间更短，出血量更小，如体内凝血试验所示。 使用 Sprague-Dawley 大鼠损伤模型的实验表明，SFG@TB加速了伤口愈合过程并减少了疤痕宽度，这伴随着更厚的肉芽组织。结论 SFG@TB复合止血海绵力学性能优异、止血性能好、生物安全性高，促进了伤口止血和组织修复。因此，SFG@TB复合止血海绵可能是一种很有前途的伤口止血材料。