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临床试验/NCT03273777
NCT03273777Unknown不适用

Comparison of Skin Incision Skewness With or Without Previous Measurement and Drawing of the Incision Line at Cesarean Section - a Randomized Controlled Trial

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
86
试验地点
1
主要终点
Skin incision skewness

研究概览

简要总结

Skin incision skewness, incision length on both sides of the midline and patient's perception of the scar after cesarean section will be compared between the following two groups: (1) Drawing of an incision line prior to skin incision and (2) no drawing of an incision line.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • First cesarean section

排除标准

  • Performance of an acute cesarean section
  • Previous cesarean section
  • Body mass index > 35 kg/m²

结局指标

主要结局

Skin incision skewness

时间窗: 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.

次要结局

  • Incision length on both sides of the midline(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))
  • Patient's perception of the scar(1 minute (before discharge from hospital))

研究者

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

Heinrich Husslein

Ass.-Prof.

Medical University of Vienna

研究点 (1)

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