A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin - Results of a randomized controlled trial

A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin - Results of a randomized controlled trial
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DOI:
10.1001/archsurg.137.3.326
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发表时间:
2002-03-01
影响因子:
--
通讯作者:
Ballard, JL
Ballard, JL
中科院分区:
其他
文献类型:
--
作者:
Glickman, M;Gheissari, A;Ballard, JL

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假设:实验性聚合物密封剂(CoSeal [Cohesion Technologies,Palo alto,Calif])提供与Gelfoam等同的吻合口密封(Upjohn,Kalamazoo,Mich)/凝血酶在人工血管移植物的手术放置中的作用。设计:随机对照试验。设置:九所大学附属医疗中心。患者:148例计划植入聚四氟乙烯移植物的患者,主要用于腹股沟下血管重建手术或建立透析通路分流,随机接受实验性干预(n=74)或对照(n=74)治疗。干预:聚四氟乙烯移植物放置后,所有对照受试者的吻合口缝合孔出血均在术中用明胶海绵/凝血酶治疗。在实验组中的受试者的聚合物密封剂直接应用到缝合线没有伴随的手动compression.Main结果Measures:主要治疗成功的定义为在10分钟内实现完全吻合口缩放的受试者的比例在每个组。受试者的比例,实现立即密封和所需的时间,以完全抑制缝合孔出血也进行了比较治疗groups.Results:整体10分钟的密封成功率是相等的(86%与80%; P= 0.29)之间的实验和对照组,分别。然而,使用CoSeal治疗的受试者实现即时吻合口闭合的比率是使用Gelfoam/凝血酶治疗的受试者的两倍多(47% vs 20%; P
Hypothesis: An experimental polymeric sealant (CoSeal [Cohesion Technologies, Palo alto, Calif]) provides equivalent anastomotic sealing to Gelfoam (Upjohn, Kalamazoo, Mich)/thrombin during surgical placement of prosthetic vascular grafts.Design: Randomized controlled trial.Setting: Nine university-affiliated medical centers.Patients: One hundred forty-eight patients scheduled for implantation of polytetrafluoroethylene grafts, mainly for infrainguinal revascularization procedures or the creation of dialysis access shunts, who were treated randomly with either an experimental intervention (n=74) or control (n=74).Intervention: Following polytetrafluoroethylene graft placement, anastomotic suture hole bleeding was treated intraoperatively in all control subjects with Gelfoam/thrombin. Subjects in the experimental group had the polymeric sealant applied directly to the suture lines without concomitant manual compression.Main Outcome Measures: Primary treatment success was defined as the proportion of subjects in each group that achieved complete anastomotic scaling within 10 minutes. The proportion of subjects that achieved immediate sealing and the time required to fully inhibit suture hole bleeding also were compared between treatment groups.Results: Overall 10-minute sealing success was equivalent (86% vs 80%; P=.29) between experimental and control subjects, respectively. However, subjects treated with CoSeal achieved immediate anastomotic sealing at more than twice the rate of subjects treated with Gelfoam/thrombin (47% vs 20%; P