Effect of Surgical Bundle with Preoperative Skin Preparation and Vaginal Cleaning versus Surgical Bundle without Preoperative Skin Preparation and Vaginal Cleaning on Prevention of Surgical Site Infections in women undergoing Caesarean Section- A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Suture Site Examination
研究概览
简要总结
**Background:**Caesarean section (CS) is the most common procedure globally with 32.1% of all deliveries. CS can be associated with Surgical Site Infections (SSIs) which can be reduced or prevented by applying proper techniques and thus, reduce the health care burden and also economic burden on the society. Hence, this study will be conducted to study the effect of surgical bundle with preoperative skin preparation and vaginal cleaning versus surgical bundle without preoperative skin preparation and vaginal cleaning on the prevention of surgical site infections in women undergoing caesarean section.
Methodology: A total of 170 women undergoing CS will be randomized into two groups following computer-generated randomization. Group A (Experimental Group) will include caesarean section with surgical bundle with preoperative skin preparation and vaginal cleaning and Group B (Control Group) will include caesarean section with surgical bundle without preoperative skin preparation and vaginal cleaning. The data will be collected following the suture site examination on day 2, day 4, and day 9.
Result: The data will be collected and will undergo statistical analysis with descriptive and inferential statistics. p-value < 0.05 will be considered statistically significant.
Conclusion: The study will conclude the effect of the surgical bundle with preoperative skin preparation and vaginal cleaning in comparison with the surgical bundle without preoperative skin preparation and vaginal cleaning on the prevention of SSIs in women undergoing CS with statistical and clinical implications and differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •Patients undergoing caesarean section both elective and emergency.
- •The patient who has given consent for the study.
排除标准
- •Patients with comorbidities like Diabetes Mellitus.
- •Patients with a body mass index of more than 30 kilograms per meter square.
- •Patients with Premature Rupture of membranes for more than 18 hours.
- •Patients with severe anemia with hemoglobin less than 7 grams per decilitre.
- •Patient with recent infections at the site of the incision before caesarean section.
- •Patients already suffering from fever.
结局指标
主要结局
Suture Site Examination
时间窗: Day 2, day 4, and day 9 post-operatively.
次要结局
未报告次要终点
研究者
Dr Shivangi Ghildiyal
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital
