The Effect of Suturing Material on Scar Healing; a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- The healing ratio
研究概览
简要总结
We want to compare the effects of 2 suture materials (monofilament and multifilament) on healing of the uterine scar after a cesarean delivery.
详细描述
Cesarean section (CS) is the most common type of obstetric surgery. When medically justified, CS can effectively prevent maternal and perinatal mortality and morbidity however, there are many short and long-term complications of CS. One of the most common complications is the CS scar defect. CS scar defects can develop after transverse incision of the lower uterine segment, which may result in prolonged postmenstrual bleeding, spotting, pelvic pain, and infertility. Suture material is an essential part of any major surgery, serving to hold opposing tissues together and accelerate the healing process, resulting in decreased scarring of the affected areas. We sought to evaluate the effects of different synthetic absorbable suture materials on cesarean scar defect formation.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnancy at term >37 weeks of gestational age
排除标准
- •history of previous cesarean section
- •history of previous uterine surgery
- •multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
- •uterine atony history
- •gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath
- •active labor (with regular uterine contractions and cervical dilatation >4 cm
研究组 & 干预措施
Monofilament suture
continuous double-layer unlocked suturing with 1.0 monofilament synthetic absorbable suture
干预措施: Monofilament suture (Other)
Multifilament suture
continuous double-layer unlocked suturing with 1.0 multifilament synthetic absorbable suture
干预措施: Multifilament suture (Other)
结局指标
主要结局
The healing ratio
时间窗: 6 months
Six months after the operation, the integrity of the cesarean scar at the uterine incision site will be assessed by hydrosonography. The healing ratio will be calculated as the thickness of the residual myometrium covering the defect, divided by the sum of the thickness of the residual myometrium covering the defect and the height of the wedge-shaped defect.
次要结局
- blood loss(24 hours)
- additional sutures(2 hours)