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Access site management after peripheral percutaneous transluminal procedures: neptune pad compared with conventional manual compression.

机译:经外周经皮腔内手术后的进入部位管理:与传统的手动按压相比,海王星垫。

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摘要

PURPOSE: To investigate the safety and efficacy of the procoagulant wound dressing Neptune Pad (Biotronik, Berlin, Germany) compared with those of conventional manual compression for access site management after peripheral percutaneous interventions. MATERIALS AND METHODS: The study was approved by the institutional ethics committee, and all patients gave written informed consent. Two hundred one consecutive patients were enrolled and were randomly assigned to be treated with the Neptune Pad (n = 100) or conventional manual compression (n = 101). Patients were followed up clinically until hospital discharge and with duplex ultrasonography at 24 hours after the procedure to evaluate occurrence of access site complications. Time to hemostasis and time to ambulation were recorded, and patient and physician discomfort were measured by using a visual analogue scale. RESULTS: The risk for access site complications was not significantly different between the Neptune Pad group and the conventional compression group (adjusted odds ratio, 1.15; 95% confidence interval: 0.47, 2.84; P = .76). Time to hemostasis was marginally reduced in the Neptune Pad group. Patient and physician discomfort were lessened with use of the device. CONCLUSION: The hemostatic device Neptune Pad does not improve the safety of access site management after peripheral percutaneous procedures. Markedly improved comfort was noted among patients in the Neptune Pad group and by the physicians obtaining hemostasis.
机译:目的:研究外周血流经皮介入治疗后与传统的手动加压相比,促凝伤口敷料海王星垫(Neptune Pad,Biotronik,德国柏林)的安全性和有效性。材料与方法:该研究得到机构伦理委员会的批准,所有患者均签署了知情同意书。连续招募了201位患者,并随机分配他们接受Neptune Pad(n = 100)或常规手动加压治疗(n = 101)进行治疗。对患者进行临床随访直至出院,并在手术后24小时进行双程超声检查以评估进入部位并发症的发生率。记录止血时间和走动时间,并使用视觉模拟量表测量患者和医生的不适感。结果:海王星垫组和常规加压组之间发生并发症的风险没有显着差异(校正比值比为1.15; 95%置信区间为0.47、2.84; P = 0.76)。 Neptune Pad组止血时间略有减少。使用该装置可减轻患者和医生的不适感。结论:止血设备Neptune Pad不能提高外周经皮手术后进入部位管理的安全性。海王星护垫组的患者以及获得止血的医生均注意到舒适性明显改善。

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