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临床试验/NCT06352853
NCT06352853已完成不适用

A Comparative Study Between the Use of Scalpel Versus Diathermy in Opening the Transverse Abdominal Skin Incision During Cesarean Section

Cairo University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Estimation of incision blood loss in both groups

研究概览

简要总结

This study aims to compare between using of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in incisional time, incisional blood loss, postoperative pain, wound healing and wound complications.

详细描述

Surgical scalpels are traditionally used for skin incisions during a Caesarean delivery; the great evolutions in electrosurgical devices bring an alternative method for skin incision by the usage of cutting diathermy.

The current comparative study was conducted in Kasr Al-Ainy hospital obstetric theaters between January 2022 and June 2022. Consents were obtained from all participants. 120 participants were included in this study, divided into 2 groups 60 in each group;Diathermy group and scalpel group respectively .

• Randomization achieved using computer generated randomization sequences. Allocation was in 1:1 ratio

In both groups:

  1. Pre-operative: patients received cefoperazone 1gm intravenous. In case of penicillin allergy, they received clindamycin intravenous.
  2. A Pfannenstiel skin incision was made taken down through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized,

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
None

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

  • •Elective cesarean section.
  • •Women with body mass index less than
  • •Transverse skin incision.

排除标准

  • •Women with medical disorder that can affect wound healing as diabetes, hypertension, chronic anemia and with chronic skin conditions as psoriasis and eczema.
  • •Women with Autoimmune disorders.
  • •Cardiac patients on pacemakers and patients on anticoagulants.

研究组 & 干预措施

Group 1: Scalpel Group

Active Comparator

A skin incision is made by traditional method, with proper homeostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeding as well as using of diathermy on coagulation mode. Then,the scalpel was used to reach peritoneum.

干预措施: Skin incision in Cesarean Section by Scalpel (Other)

Group 2: Diathermy Group

Active Comparator

A skin incision is made using a small flat blade pen electrode, set on cutting mode and delivering a 120-wat (maximum) sinusoidal current, electrosurgical cutting performed without pressure or mechanical displacement. Then, we used the scalpel to reach peritoneum.

干预措施: Skin incision in Cesarean Section by Diathermy (Other)

结局指标

主要结局

Estimation of incision blood loss in both groups

时间窗: 5 months

incision blood loss volume was measured by weighing the swabs pre and postoperatively (1mg = 1ml).

Skin incision time in scalpel versus diathermy group

时间窗: 5 months

The incision time was estimated by using digital clock, time established as follows: when skin incision made, the surgeon called out "start the clock". After opening the rectus sheath, the surgeon called out" stop the clock". Incision time is the difference between "start" and "stop".

次要结局

  • Postoperative wound healing in both groups(5 months)
  • Postoperative pain in both groups(5 months)

研究者

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

Shaimaa Mostafa Mohammed Refaay El shemy

Lecturer at Obstetrics and Gynecology department

Cairo University

研究点 (1)

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