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临床试验/NCT02720913
NCT02720913已完成不适用

COR-KNOT Versus Manually Hand-tied Knots

The Cleveland Clinic0 个研究点目标入组 50 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Time (seconds) required to use COR-KNOT vs. Standard Suture Tying

研究概览

简要总结

The COR-KNOT technology (LSI SOLUTIONS, Victor, New York USA) was developed to replace suture tying with a faster procedure during surgery. While preclinical studies confirmed the speed of COR-KNOT use, no clinical studies have quantitatively compared the speed of suture fixation delivered by the COR-KNOT device with the speed of conventional hand-tied knots. COR-KNOT is expensive, costing 189 $ per application. Given this added expense, it is important to quantify the time-saved by application of this technology.

详细描述

The COR-KNOT device was developed to make suture fixation faster and save operative time. With a single squeeze of the lever, the device remotely and automatically secures sutures with a titanium fastener, while also simultaneously trimming excess suture tails. This device has been accepted by cardiac surgeons for the recognized benefits of time savings, simplicity, and reliability.

While the device presents ergonomic advantages during minimally invasive cardiac surgery, it enjoys widespread use in sternotomy-based, standard heart surgery. The relative cost of the device as a function of time saved has not been assessed. The purpose of this trial is to determine the relative time savings and cost of COR-KNOT compared to standard hand-tied knots in patients undergoing mitral/tricuspid ring annuloplasty repairs via traditional open heart surgery. Valve repair surgery is a common setting for COR-KNOT use and therefore serves as an appropriate procedure for evaluation of the technology.

The investigators propose a prospective, randomized trial in patients undergoing mitral or tricuspid ring annuloplasty repair to 1) Determine the time require per knot for COR-KNOT versus standard hand-tied knots and 2) Quantify the relative cost of COR-KNOT versus that of standard, hand-tied knots. Data from this study will enable the investigators to determine the cost-benefit of using COR-KNOT technology in cardiac surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Scheduled for Valvular ring annuloplasty for mitral and/or tricuspid valve repair
  • •Age > 18 years
  • •Able and willing to give informed consent

排除标准

  • 未提供

研究组 & 干预措施

COR-KNOT

Experimental

The COR-KNOT device was developed to make suture fixation faster and save operative time. With a single squeeze of the lever, the device remotely and automatically secures sutures with a titanium fastener, while also simultaneously trimming excess suture tails.

干预措施: COR-KNOT (Device)

Standard Suture Tying

Active Comparator

Standard Suture Tying

干预措施: Standard Suture Tying (Procedure)

结局指标

主要结局

Time (seconds) required to use COR-KNOT vs. Standard Suture Tying

时间窗: 60 seconds

次要结局

  • Cost (US Dollar) of using COR-KNOT vs. Standard Suture Tying(60 seconds)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Gillinov, MD

MD

The Cleveland Clinic

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