Efficacy of Diathermy on Healing Power of Cesarean Section Scar:A Randomized Control Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Cosmosis
研究概览
简要总结
To compare the effects of electro-surgery on healing power as a primary outcome (from skin to the peritoneum. And volume of blood loss, incision time and postoperative surgical wound pain as secondary outcomes.
详细描述
This is a prospective study is carried out at Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department, Faculty of medicine in women undergoing CS through pfannentiel incisions.
All women will receive intravenous antibiotic prophylaxis according to the Ain Shams guideline, 1 g of cefazolin given at the time of incision.
Diathermy incisions will be carried out using monopolar blade pen electrode, set on cutting mode and delivering a 35 continuous current. Electrosurgical cutting will be performed without pressure or mechanical displacement.
'Bleeders' will be controlled by using diathermy, on coagulating mode, and will be applied to a hemostat on the vessels.
Incisions made by the scalpel will be done by the traditional method, with proper hemostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeders.
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
- Double (Care Provider, Investigator)
盲法说明
allocation done by a person not involved in the study.
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
- •Primi-section
- •BMI (18-29) kg/m^
- •Age from (18-40).
- •Women undergoing CS with Pfannenstiel incision.
排除标准
- •Women with one of the following conditions:
- •Patients requiring midline incision or on anti-coagulant therapy
- •Cardiac patients on pacemakers and patients with chronic diseases expected to affect wound healing, such as diabetes, liver diseases, chronic anemia and renal impairment
- •Obese patients BMI (>30) kg/m^2.
结局指标
主要结局
Cosmosis
时间窗: 15 days after CS
The primary objective is to compare healing power between two methods then will be followed at 3, 7, 11, and 15 days post-operative using: Visual Analogue Scale The original VAS consisted of a 100-mm line with "worst scar" at the right end of the line and "best scar" at the left end of the line. In this study, VAS ranged from 0 to 10cm. Using the line as a continuous entity, the patient mark on the line where they thought the scar fit.
Healing power
时间窗: 15 days after cs
The wound score addresses 6 clinical variables: absence of stepoff, contour ir- regularities, wound margin separation \>2 mm, edge inversion, excessive distortion, and overall cosmetic appearance. Each of these categories is graded on a O-or-l-point scale. A total cosmetic score is derived by the addition of the scores of the 6 categorical variables. A score of 6 is considered optimal, while a score of ≤5 suboptimal.
次要结局
- postoperative surgical wound pain: VAS scale(24 hours)
研究者
Mohamed abd elfatah elsenity
Lecturer of obstetrics and gynecology
Ain Shams University