Skin Incision Skewness at Cesarean Section
Comparison of Skin Incision Skewness With or Without Previous Measurement and Drawing of the Incision Line at Cesarean Section - a Randomized Controlled Trial
研究概览
详细说明
Some aspects of the surgical techniques employed during cesarean section have already been evaluated in regards to possible improvements of cosmetic outcome, such as the use of different skin closure materials or whether subcutaneous fat suture closure leads to better results than non-closure. Another point to be considered is the skewness of the scar. Many surgeons make the skin incision based on their experience without prior measurement and drawing of an incision line. However, following a predefined incision line may reduce the rate of skew incisions. Therefore, this study aims to compare these two approaches to the skin incision.
Participating women will be recruited at the Department of Obstetrics and Gynecology of the Medical University of Vienna. They will be included into the study after written informed consent and will be randomized into one of the two groups (drawing of an incision line prior to skin incision versus no drawing of an incision line) on the day of cesarean section.
Skewness of the skin incision in each group will be assessed after cesarean section. Furthermore, it will be determined whether there are any differences in the incision length on both sides of an imaginary line from the umbilicus to the clitoris between these two techniques. Additionally, patient's perception of the scar before discharge from hospital will be assessed.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Vienna、奥地利
- 招聘中
- Medical University Vienna
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接触：
- Heinrich Husslein
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 18 years
- First cesarean section
Exclusion Criteria:
- Performance of an acute cesarean section
- Previous cesarean section
- Body mass index > 35 kg/m²
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Drawing of an incision line
An incision line of 14 cm will be drawn using a conventional surgical ruler and pen before skin incision.
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Drawing of an incision line prior to skin incision at cesarean section
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无干预：No drawing of an incision line
Skin incision will be carried out without previous drawing of an incision line.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Skin incision skewness
大体时间：10 minutes (from a photograph taken at the end of the operation)
|
Skewness of the incision will be assessed using digital photos and an appropriate software.
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10 minutes (from a photograph taken at the end of the operation)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incision length on both sides of the midline
大体时间：2 minutes (1 minute for measurement at the end of the operation and 1 minute postoperatively from a photo taken at the end of the operation)
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The length will be measured in cm.
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2 minutes (1 minute for measurement at the end of the operation and 1 minute postoperatively from a photo taken at the end of the operation)
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Patient's perception of the scar
大体时间：1 minute (before discharge from hospital)
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Skewness and length of the scar are rated by the patient.
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1 minute (before discharge from hospital)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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