Comparative Study Between Scalpel and Diathermy Skin Incision in Repeated Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 476
- 试验地点
- 1
- 主要终点
- incision time
研究概览
简要总结
This study was performed to compare both methods of skin incisions to determine differences in postoperative pain, hemodynamic changes, incisional time, blood loss during incision, wound healing, and wound complication.
详细描述
Our study aims to compare the use of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in
- incision time,
- incision blood loss,
- hemodynamic changes,
- postoperative pain,
- wound healing
- wound complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with a history of only one previous cesarean section
- •age between 18 and 40 years
- •gestational age of 38 to 41 weeks
- •body mass index less than 30.
排除标准
- •any medical disorder that can affect wound healing as diabetes, chronic anemia, chronic skin conditions, history of allergy, or history of an infected surgical wound.
- •Women who conducted primary or emergency cesarean deliveries
- •cardiac patients on pacemakers
- •patients on anticoagulants
- •women refusing to participate in the study
结局指标
主要结局
incision time
时间窗: during surgical operation. the difference between starting skin incision till the rectus sheath was visualized
We compared incisional time by using a digital clock. The incisional time was established as follows: when skin incision was made, the surgeon called out "start the clock". Once the rectus sheath was visualized, the surgeon calls out "stop the clock". The incision time was the difference between "start" and "stop".
incision blood loss
时间窗: during surgery
This was calculated by weighing the swabs pre and postoperatively (1mg = 1ml) after complete hemostasis was achieved.
postoperative pain
时间窗: during the first day after surgery
We compared those patients clinically for postoperative pain for 24 hours by visual analog scale (VAS) score, a psychometric response scale, and it is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. It is 11 points numeric scale ranges from "0" representing one pain extreme (e.g., no pain) to "10" representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable"). This score was recorded for each participant at 2,4,6,8,10,12,24 hours postoperatively.
次要结局
- wound healing(during the first week after surgery)
- wound complications(during the first week after surgery)
研究者
Mazen Abdel Rasheed
Researcher
National Research Centre, Egypt