NCT04220294已完成不适用
Surgical Site Infection Rate After Subcutaneous Continuous Versus Interrupted Sutures During Cesarean Section.
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
- 1,238
- 试验地点
- 1
- 主要终点
- Surgical site infection rate.
研究概览
简要总结
A comparison of the rate of surgical site infections after cesarean section depending on the type of suture used for subcutaneous closure-continuous versus interrupted.
详细描述
Patients at term that are candidates for elective cesarean section will receive an explanation regarding the study and sign informed consent. Patients will then be divided randomly to one of 2 treatment groups based on the type of subcutaneous tissue closure:
- Interrupted sutures.
- Continuous sutures. Information regarding medical and obstetric history will be collected for each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women undergoing elective cesarean section.
- •Subcutaneous tissue layer>2 centimeter according to ultrasound.
排除标准
- •Non-elective CS.
- •Fever during the 48 hours prior to surgery.
- •Antibiotic treatment during the 48 hours prior to surgery.
- •Inability to give informed consent.
- •Preterm delivery (< 37 weeks' gestation).
- •Fetal death.
- •Known fetal anomalies or placental abnormalities.
- •Immunosuppressive conditions.
研究组 & 干预措施
Interrupted sutures
Active Comparator
Subcutaneous tissue closure by interrupted sutures.
干预措施: Subcutaneous tissue closure (Procedure)
Continuous sutures
Active Comparator
Subcutaneous tissue closure by continuous sutures.
干预措施: Subcutaneous tissue closure (Procedure)
结局指标
主要结局
Surgical site infection rate.
时间窗: From admission up to 6 weeks postpartum.
Surgical site infection rate.
次要结局
- Rate of re-admission due to surgical site infection.(From admission up to 6 weeks postpartum.)
- Rate of postoperative febrile morbidity.(From admission up to 6 weeks postpartum.)
- Rate of maternal fever.(From admission up to 6 weeks postpartum.)
- Duration of maternal fever.(From admission up to 6 weeks postpartum.)
- Rate of antibiotic use for the treatment of surgical site infection.(From admission up to 6 weeks postpartum.)
- Cesraean section-to-surgical site infection time interval.(From admission up to 6 weeks postpartum.)
- Rate of bacteremia.(From admission up to 6 weeks postpartum.)
- Rate of sepsis.(From admission up to 6 weeks postpartum.)
- Post-operative duration of hospitalization.(From admission up to 6 weeks postpartum.)
- Postoperative pain.(From admission up to 6 weeks postpartum.)
- Rate of postoperative anemia.(From admission up to 6 weeks postpartum.)
- Blood transfusion rates.(From admission up to 6 weeks postpartum.)
- Breastfeeding rates.(From admission up to 6 weeks postpartum.)
- rate of voiding problems.(From admission up to 6 weeks postpartum.)
- Venous thromboembolism rates.(From admission up to 6 weeks postpartum.)
- Rate of admission to intensive care unit.(From admission up to 6 weeks postpartum.)
- Maternal death rate(From admission up to 6 weeks postpartum.)
研究者
ROY LAUTERBACH MD
Principal investigator
Rambam Health Care Campus
研究点 (1)
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