Early Versus Late Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Patient and Observer Scar Assessment Scale (POSAS) scores.
研究概览
简要总结
The optimal choice of skin closure at cesarean delivery has not yet been determined. This study aim to study the wound complications and scar healing after Surgical staples removal at postoperative day 4 and day 8 .
A randomized control trial.
详细描述
A randomized controlled trial in which pregnant women undergoing a scheduled Elective cesarean delivery were assigned to skin closure with surgical staples and were randomly assigned to the day of removal of surgical staples. Postoperative day 4 VS. Postoperative day 8 .
Outcome assessors were blinded to group allocation. Scars will be evaluated after 8 weeks. Primary outcome measures is Patient and Observer Scar Assessment Scale (POSAS) scores. Secondary outcome measures are complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).
A group of 104 women is needed in order to achieve a clinically significant effect with a power of 80%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •elective cesarean delivery
- •previous cesarean delivery performed using the Pfannenstiel method
- •36-41 weeks of gestation based on first trimester ultrasound and a viable fetus.
排除标准
- •emergency cesarean delivery
- •clinical signs of infection at the time of CD, uncontrolled
- •vunblanaced diabetes mellitus
- •history of keloids
研究组 & 干预措施
POD4
REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4
干预措施: Removal of surgical clips at day 4 post operative vs day 8 post operative (Other)
POD4
REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 4
干预措施: Elective cesarean delivery (Procedure)
POD8
REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8
干预措施: Removal of surgical clips at day 4 post operative vs day 8 post operative (Other)
POD8
REMOVAL OF SURGICAL STAPLES AT POSTOPERATIVE DAY 8
干预措施: Elective cesarean delivery (Procedure)
结局指标
主要结局
Patient and Observer Scar Assessment Scale (POSAS) scores.
时间窗: 8 weeks postoperative
次要结局
- complications of surgical site infection (SSI) or wound disruption (hematoma or seroma).(8 weeks postoperative)