COMPARISON OF ELECTRO-CAUTERY WITH SCALPEL FOR ELECTIVE LOWER ABDOMEN INCISIONS– A RANDOMISED CONTROL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of Incision procedure assessment parameters (1. Incision time,2. Incisional blood loss,3. Post operative pain and use of analgesics,4. Wound infection rates,5. Cosmesis 6. Thermal injury)
研究概览
简要总结
Patients fulfilling inclusion criteria who are willing to give written informed consent will be included in the study and will be randomly allocated using lottery method in one of the two groups. Patients will be counselled about the merits and demerits of both incisions and informed consent will be obtained for the study.
**Group 1 (Electro-cautery incision):**Incision will be taken using cutting current from an electrocautery device, set to pulse sine wave of 70 watts. Haemostasis will be achieved with forceps coagulation.
**Group 2 (Scalpel incision):**Skin incision will be taken with a conventional surgical blade mounted on a BP handle.
All the patients will be operated under spinal anaesthesia. All the patients undergoing clean procedure will receive 1gram cefotaxime intravenously, clean contaminated procedure will receive 1 gram of cefotaxime and metronidazole 500mg intravenously 30 mins prior to the commencement of procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients admitted under general surgery undergoing elective lower abdomen surgeries
- •Subjects Willing to provide the Informed Consent.
排除标准
- •Emergency procedures 2) Recurrent surgeries.
结局指标
主要结局
Comparison of Incision procedure assessment parameters (1. Incision time,2. Incisional blood loss,3. Post operative pain and use of analgesics,4. Wound infection rates,5. Cosmesis 6. Thermal injury)
时间窗: Day 1, Day 2, Day 3, Day 10, Day 30
次要结局
- Overall Safety(Day 1, Day 2, Day 3, Day 10, Day 30)