A Randomized Controlled Trial of Tegaderm Vs. Transpore for Eye Protection During Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 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
- 是
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
研究组 & 干预措施
Tegaderm Left
After general anesthesia is administered, Tegaderm will be placed on the left eye and Transpore will be placed on the right eye
干预措施: Tegaderm Eye Tape (Device)
Transpore Right
After general anesthesia is administered, Transpore will be placed on the right eye and Tegaderm will be placed on the left eye.
干预措施: Transpore Eye Tape (Device)
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)