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临床试验/NCT03134209
NCT03134209已完成不适用

A Single-center, Phase IV, Randomized, Prospective Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
Visual Analog Scale (VAS) for Pain

研究概览

简要总结

A single-center, phase IV, randomized, prospective study investigating the efficacy of various wound closure devices in reducing postoperative wound complications.

详细描述

The zipper wound technology is a new wound closure device that is an alternative to the commonly used conventional staples and sutures. The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin. The other treatment groups include monocryl + Dermabond (conventional sutures and skin adhesive glue) and polyester mesh + Dermabond. All products have been FDA approved. A randomized control trial will provide the highest level of evidence without altering the potential risks to the patient as all three wound closure techniques have been found to have comparable complication rates. The three different treatment devices will be administered following the normal standard of care. All three wound closure devices are currently being used at NYULMC. No modifications to the normal standard of practice other than the randomization process will be implemented. Given the nature of the application of the wound closure device, which will be visible to the surgeon at the time of application and the patient postoperatively, the study will not be blinded to either the surgeon or the patient. Prior to discharge, a blinded plastic surgeon will be asked to assess the wound based on comesis and overall quality of wound healing.

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

入选标准

  • Patients who are undergoing joint arthroplasty

排除标准

  • Treatment of total joint replacement surgery at an outside institution

结局指标

主要结局

Visual Analog Scale (VAS) for Pain

时间窗: 4 Days

The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity along a horizontal line, and this rating is then measured from the left edge. The total range of score is 0-10; the higher the score the worse the pain (0 = no pain, 10 = worst pain imaginable).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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