A Randomised Controlled Trial on the Timing of Wound Dressing Removal After Emergency Caesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Cesarean wound complication
研究概览
简要总结
An open labelled randomised trial on the timing of wound dressing removal for emergency caesarean delivery in labour.
详细描述
The trial is unblinded randomised trial on surgical wound dressing at 24 versus 48 hours after the emergency caesarean delivery in labour.
The primary outcome is the prevalence of wound complications (hematoma, seroma, infection/ dehiscence) The secondary objectives are the maximum pain after the surgery (in ward) and the timing of the patient's first bath after the surgery
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Lower segment caesarean delivery
- •Primary or repeat caesarean delivery
- •Caesarean section in active phase of labour.
- •Regional anaesthesia
排除标准
- •Upper segment or classical caesarean delivery
- •Massive postpartum haemorrhage > 1.5 litre
- •Pre-delivery chorioamnionitis
- •Skin closure using interrupted suture
- •Acquired or congenital coagulation disorder
- •Associated medical or obstetric condition requiring prolonged hospital stay after delivery such as severe pre-eclampsia, uncontrolled diabetes mellitus, cardiac disease, systemic infection.
- •Inability to give consent
研究组 & 干预措施
Dressing removal at 24 hours
The wound dressing will be removed 24 hours after emergency cesarean delivery
干预措施: Cesarean wound dressing removal (Procedure)
Dressing removal at 48 hours
The wound dressing will be removed 48 hours after emergency cesarean delivery
干预措施: Cesarean wound dressing removal (Procedure)
结局指标
主要结局
Cesarean wound complication
时间窗: 30 days
Hematoma, seroma, wound infection, wound dehiscence
次要结局
- Pain control(48 hours)
- Self hygiene(48 hours)
研究者
Zahar Azuar Zakaria
Consultant, Head of Department, Lead Investigator
Hospital Kemaman