Broekema Ferdinand I, Van Leeuwen M Barbara M, Van Minnen Baucke, Bos Rudolf R M
Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Department of Biomedical Engineering, W.J. Kolff Institute, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
J Biomed Mater Res A. 2015 Nov;103(11):3666-75. doi: 10.1002/jbm.a.35492. Epub 2015 Sep 12.
Most topical hemostatic agents are based on animal-derived products like collagen and gelatin. They carry the potential risk of pathogen transmission while adjustments in the production process of these materials are limited. A synthetic hemostatic agent based on polyurethane (PU) and polyethylene glycol (PEG) was developed to overcome these disadvantages. The goal of this study was to compare the degradation process of this biomaterial to collagen and gelatin hemostatic agents. Samples of the test materials were implanted subcutaneously in both rats and rabbits. The animals were sacrificed at certain time intervals up to three years and the explanted samples were microscopically assessed. The histological examination showed a comparable pattern of degradation for the different test materials. Remnants of gelatin and collagen were seen up to 26 and 39 weeks, respectively. For PU, it took up to three years before micro-particles of the material were no longer detected. All biomaterials showed a good biocompatibility and no severe foreign body reactions occurred. The good biocompatibility and predictable pattern of resorption indicate that PU can be used as a topical hemostatic agent. However, a degradation time comparable to collagen and gelatin would be favorable.
大多数局部止血剂基于胶原蛋白和明胶等动物源产品。它们存在病原体传播的潜在风险，同时这些材料生产过程中的调整有限。为克服这些缺点，研发了一种基于聚氨酯（PU）和聚乙二醇（PEG）的合成止血剂。本研究的目的是比较这种生物材料与胶原蛋白和明胶止血剂的降解过程。将测试材料样本皮下植入大鼠和兔子体内。在长达三年的特定时间间隔处死动物，并对取出的样本进行显微镜评估。组织学检查显示不同测试材料的降解模式具有可比性。分别在26周和39周时仍可见到明胶和胶原蛋白的残留。对于PU，直至三年后才不再检测到该材料的微粒。所有生物材料均表现出良好的生物相容性，未发生严重的异物反应。良好的生物相容性和可预测的吸收模式表明PU可作为局部止血剂使用。然而，与胶原蛋白和明胶相当的降解时间会更有利。
