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临床试验/NCT02493608
NCT02493608已完成不适用

Scalpel vs Diathermy in Making Abdominal Wall Incision During Repeat Cesarean Delivery

Texas Tech University Health Sciences Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Incision Time .

研究概览

简要总结

The objective of this study is to compare scalpel vs. diathermy in abdominal wall incision in pregnant patients undergoing repeat elective cesarean delivery.

详细描述

It is hypothesized that wall incisions made by diathermy compared to scalpel during repeat cesarean delivery will have less incision time, as well as less blood loss. A second hypothesis is that the use of diathermy, compared with scalpel will not increase in post-operative pain.

  1. This is a randomized prospective study in women undergoing elective repeat cesarean delivery at Medical Center Hospital in Odessa Texas.
  2. Women undergoing cesarean delivery will be randomized into two groups: One group will undergo diathermy to incise the entire abdominal wall ,which includes skin, subcutaneous tissue, rectus muscle until the peritoneal cavity is visible. On the other group scalpel will be used to achieve the same aim.
  3. A standardized abdominal wall incision will be made with either diathermy in cut mode or scalpel. Diathermy will be set in a cut mode with standard setting as per surgeons preference. All patients in the study will get standard skin incision in terms of length and depth which will be marked by a ruler.
  4. Incision time ( measured in minutes and seconds with stop watch) and amount of bleeding will be measured. Blood loss will be calculated by weighing (in grams) the "used" lap sponges and comparing this to the weight (in grams0 of "fresh" lap sponges.
  5. Post-operative pain will be measured by a Visual Analogue Scale (VAS). Measurements will be taken at 6:00 to 7:00 AM from post -op day 1 until hospital discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Multiparous pregnant women 18 - 45 years.
  • Gestational ages 37 weeks to 41 weeks,
  • Undergoing repeat elective or repeat emergency cesarean deliveries.

排除标准

  • Informed consent can't be obtained in a manner that allows for no impression of undue influence/pressure or sufficient time for patient to consider participation.
  • Primary Cesarean deliveries - as these can bias the selection.
  • Skin conditions such as infections, psoriasis, and eczema.

结局指标

主要结局

Incision Time .

时间窗: during surgery

Time to make an abdominal wall incision from skin to rectus fascia.

次要结局

  • Blood Loss(Blood lost during incision/surgery)
  • Post Operative Pain(Post Operative Day (POD) 1 and Day 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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