Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section: a Randomized Clinical Trial (WISHES Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Composite wound evaluation scale after caesarean delivery
研究概览
简要总结
This investigator-initiated, open-label, randomized controlled trial will explore the effects of two treatment arms, comparing standard treatment with normal saline against Irrisept, a jet lavage solution containing a low concentration of Chlorhexidine Gluconate (CHG) at 0.05% in 99.95% sterile water for irrigation. The study aims to evaluate the impact on postoperative wound healing in patients who have undergone cesarean delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Singleton pregnancy
- •Planned cesarean delivery at gestational age 37 weeks or later at Loma Linda University Children's Hospital
- •Planned post-operative follow up with Loma Linda OBGYN
- •Speak English or Spanish
- •At least one of the following medical complications: Obesity BMI>= 30kg/m2, Diabetes, Spontaneous rupture of membranes, Intraamniotic infection
排除标准
- •Emergency cesarean delivery
研究组 & 干预措施
Irrisept
The experimental arm will receive irrigation solution Irrisept administered through a proprietary bottle (jet lavage) following the closure of the fascia in Cesarean section.
干预措施: Irrisept (Device)
Normal Saline
The active comparator arm will receive the standard of care irrigation solution, normal saline, administered via standard pour over following the closure of the fascia in Cesarean section.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Composite wound evaluation scale after caesarean delivery
时间窗: Up to 8 weeks postop
Wound Evaluation scale will be used to evaluate appropriate healing in the following categories: redness, bruising, discharge, tissue breakdown, wound infection
次要结局
未报告次要终点