Sasajima T, Inaba M, Azuma N, Koshiko S, Kubo Y
First Department of Surgery, Asahikawa Medical College, Japan.
Nihon Kyobu Geka Gakkai Zasshi. 1995 Sep;43(9):1639-45.
We investigated the biological response and biodegradation of CL301, a presealed woven Dacron prosthesis (UBE woven) with glutaraldehyde stabilized gelatin. The sealant does not affect its handling characteristics because of the glycerin treatment. The total content of endotoxin in the CL301 was 5.3 +/- 0.5 pg/mg of sealant material (1.7 +/- 0.2 pg/cm2), which was 1/5 and 1/6 of that found in Hemashield and Gelseal, respectively. The pyrogen test was negative and the content was estimated below the minimum pyrogenic doses for thoracic aortic surgery. Five cm-long grafts with a diameter of 10 mm were implanted into the descending thoracic aorta of dogs weighing 10-16 kg. These grafts were retrieved 2 hours, 7, 10 days, 5, 8 and 10 weeks after implantation. Thrombus-free surfaces were 28%, 77%, at 5 and 10 weeks and there was no excessive inflammatory response to the sealant. The total, and the effective sealant remaining were 80.6%, 56.5% at 5 weeks, 60.8%, 38.3% at 10 weeks, respectively. The sealant was removed more rapidly from the inner surface than from the outer. In half of the graft area, the sealant was removed or detached from the Dacron surface 5 weeks after implantation, indicating that delayed resorption of the sealant substantially did not affect the healing process. We conclude that because of the harmless amount of endotoxin and effective sealing for 5 weeks, followed by an acceptable healing process experimentally, CL301 is the presealed Dacron graft of choice for thoracic aortic surgery.
我们研究了CL301（一种用戊二醛稳定化明胶预密封的机织涤纶人工血管（UBE机织血管））的生物学反应和生物降解情况。由于甘油处理，密封剂不影响其操作特性。CL301中内毒素的总含量为5.3±0.5 pg/mg密封剂材料（1.7±0.2 pg/cm²），分别是Hemashield和Gelseal中内毒素含量的1/5和1/6。热原试验呈阴性，估计该含量低于胸主动脉手术的最低致热剂量。将直径为10 mm、长5 cm的移植物植入体重10 - 16 kg犬的降主动脉。在植入后2小时、7天、10天、5周、8周和10周取出这些移植物。在5周和10周时，无血栓表面分别为28%和77%，对密封剂没有过度的炎症反应。在5周时，密封剂总量和剩余有效密封剂分别为80.6%、56.5%，在10周时分别为60.8%、38.3%。密封剂从内表面的去除速度比外表面快。在植入5周后，在一半的移植物区域，密封剂从涤纶表面去除或分离，这表明密封剂的延迟吸收基本上不影响愈合过程。我们得出结论，由于内毒素含量无害且能有效密封5周，随后在实验中愈合过程可接受，CL301是胸主动脉手术中首选的预密封涤纶移植物。
