Department of Clinical Sciences, Swedish University of Agricultural Sciences, Uppsala, Sweden.
J Biomater Appl. 2013 May;27(8):961-6. doi: 10.1177/0885328211431018. Epub 2011 Dec 29.
A prospective clinical trial was performed to evaluate applicability, hemostatic efficiency, and long-term tissue reactions of a novel medical device. The device was made of polydioxanone and designed in principle as a cable-tie with a flexible band running through a locking case. It was tested for ligation of the ovarian pedicles during ovariohysterectomy in nine intact female dogs. The dogs were followed-up monthly by physical examination and ultrasonography of the abdomen for 5-12 months after surgery. Macroscopic and histological post mortem examinations were performed in two dogs 7 and 18 months after surgery. Hemostasis was achieved with the devices although 1 of the 18 devices needed further tightening during a reoperation. Ultrasonography revealed a hyperechoic device that caused acoustic shadowing, which decreased over time indicating gradual resorption. Post mortem examinations demonstrated adhesions and a local transient tissue reaction at site of the device. The results show that the device may be a future alternative for ligation of ovarian pedicles in dogs.
一项前瞻性临床试验评估了一种新型医疗器械的适用性、止血效果和长期组织反应。该器械由聚二恶烷酮制成,原理上设计为带有穿过锁定盒的柔性带的结扎线。在 9 只完整雌性犬的卵巢子宫切除术期间,对其用于结扎卵巢蒂进行了测试。手术后,通过体格检查和腹部超声检查,在 5-12 个月内每月对犬进行随访。在手术后 7 个月和 18 个月,对两只犬进行了大体和组织学的尸检检查。虽然在 18 个器械中的 1 个需要在再次手术时进一步收紧,但器械实现了止血。超声检查显示器械呈高回声,导致声影,随着时间的推移逐渐减少,表明逐渐吸收。尸检检查显示器械部位有粘连和局部短暂的组织反应。结果表明,该器械可能成为犬卵巢蒂结扎的未来替代方案。