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OBJECTIVE: To evaluate the effectiveness and safety of self-prepared absorbable hemostatic fibrils. METHODS: A kind of absorbable hemostatic fibrils were prepared by self-developed patent technique. The physical form and molecular structure of the fibrils and a marketed product Surgicel (®) were characterized by general observation and infrared spectroscopy; the carboxyl content, pH value and relative molecular mass of fibrils were determined by potentiometric titration method, pH meter and copper ethylenediamine method, respectively. The behavior of the fibrils and Surgicel (®) in contact with blood was observed by inverted microscope, the cytotoxicity was evaluated by agarose diffusion cell assay in vitro. The external iliac artery hemorrhage model and the back muscle infiltration model in rats were established. The hemostatic effectiveness of the fibrils was investigated by hemostasis time and blood weight, and the degradation and biosafety of fibrils were investigated by observation photography, immune organ weighing, hematology and coagulation index measuring, and histopathological examination. RESULTS: The fibrils and Surgicel (®) had similar molecular structures. Compared with the raw material regenerated cellulose, the typical carboxyl stretching vibration absorption peak of –COOH appeared near 1727 cm (–1) in both fibrils and Surgicel (®). The carboxyl content of the two materials was about 20%, and the pH value was about 3. The relative molecular mass of the fibers after oxidation was 4466±79, which was close to that of Surgicel (®)( P>0.05). After contacting with blood, the volume of fibrils and Surgicel (®) expanded, and absorbed blood of dozens of times as their own weight. The results of agar diffusion test showed that the fibrils had no cytotoxicity. The results of animal experiments showed that the hemostasis completed within 2 min, and there was no significant difference in blood weight and speed of hemostasis between two products (both P>0.05). The fibrils could be degraded 1 week after being implanted to the bleeding sites of the muscle. There were no pathological effects on the appearance, body weight, food intake, immunological tissue thymus, spleen, lymph nodes, hematology and coagulation indexes of the rats, and no obvious abnormality found in the histopathological examination. CONCLUSION: The prepared absorbable hemostatic fibrils have excellent biological safety and effectiveness. |
