Impact of asepsis bundle on cesarean surgical site among women undergoing repeat caesarean delivery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Numbers of patients developing surgical site infections within 30 days after caesarean
研究概览
简要总结
Surgical site infections are complications associated with caesarean sectionwhich may lead to a substantial effect on the mother’s health and impose enormous demandson healthcare-system resources. Significant association has been observed between repeatcaesarean sections and wound infection. Asepsis bundle includes a set of evidence-basedmeasure that have shown a significant improvement in patient care.
The aim of this trial is to study the impact of ASEPSIS bundle on caesarean surgical site among womenundergoing repeat caesarean delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Pregnant women with period of gestation more than 28 weeks undergoing elective 2.repeat caesarean section not in labor.
- •3.History of previous one or two caesarean sections 4.Willing to follow up in UCMS & GTB Hospital.
排除标准
- •Patients with leaking per vaginum or chorioamnionitis
- •Patients with the following high risk factors at the time of recruitment will be excluded 2a Moderate or Severe anemia 2b Gestational or pre-gestational diabetes mellitus 2c Immunocompromised patients 2d BMI >30 kg/m2 2e Smoking 3 Patients with history of surgical site infection in the previous caesarean scar.
- •4 Any skin condition around surgical site 5 Patients allergic to chlorhexidine.
结局指标
主要结局
Numbers of patients developing surgical site infections within 30 days after caesarean
时间窗: At Day 3 | At Day 14 | At Day 21 | At Day 30
delivery, defined as superficial, deep or organ space infection according to Centers for
时间窗: At Day 3 | At Day 14 | At Day 21 | At Day 30
Disease Control and Prevention(CDC) and National Healthcare Safety Network (NHSN)
时间窗: At Day 3 | At Day 14 | At Day 21 | At Day 30
in both the groups.
时间窗: At Day 3 | At Day 14 | At Day 21 | At Day 30
次要结局
- Number of patients having adverse effect of bundle components(at baseline)
- Length of hospital stay (in days) in both groups(at time of discharge)
- Number of patients undergoing resuturing in both groups(within 30 days)
- Organism isolated in pus culture(at time of infection)