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临床试验/NCT04918290
NCT04918290已完成不适用

A Randomized Controlled Trial of Tegaderm Vs. Transpore for Eye Protection During Anesthesia

Tufts Medical Center2 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2021年6月11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
165
试验地点
2
主要终点
The proportion of eyelids with erythema at the end of surgery after removal of Tegaderm vs. Transpore

研究概览

简要总结

The purpose of this study is to compare the rate of eyelid erythema after anesthesia with the use of TegadermTM vs. the Transpore®. Our null hypothesis is that the rate of erythema will be similar between the two groups given there is no evidence currently to suggest otherwise

详细描述

At Tufts Medical Center, a variety of adhesive tapes are used to shut the eyes during anesthesia, including 3MTM TegadermTM and the Sharn Anesthesia Transpore®, with no preference for one or the other. While all of these products decrease the risk of corneal abrasion, none of these products have been shown to be superior to the others in terms of eyelid irritation. According to Sharn Anesthesia, "The [Transpore®] adhesive is light enough to reduce damage to the outer eye" (3). However, there is no scientific evidence to support this claim. All the investigators know is that the Transpore is coated with a medical grade, pressure-sensitive acrylic adhesive and that there are no phthalates, it is latex free and silicone free.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • At least 18 years old
  • Surgeries scheduled for anesthesia of any duration

排除标准

  • Any patient that does not consent
  • Any patient who has:
  • Pre-existing eyelid erythema or other eyelid trauma
  • Eyelid piercings
  • Any surgery on the head, brain, neck, teeth, mouth, eyes, or face
  • Surgery in the prone position
  • Patients less than 18 years old

结局指标

主要结局

The proportion of eyelids with erythema at the end of surgery after removal of Tegaderm vs. Transpore

时间窗: Immediately after tape removal

Degree of erythema seen in the photo taken of the eyelid immediately after the tape is removed after surgery

次要结局

  • Edema(Immediately after tape removal)
  • Epidermal Change(Immediately after tape removal)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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