Barbed Suture: A Look at Its Use for Hysterotomy Closure During Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Quantitative Blood Loss
研究概览
简要总结
This is a randomized controlled trial. The purpose of this study is to see if patients whose uterine incision (hysterotomy), at the time of scheduled cesarean section, is closed with barbed suture, have less blood loss compared to women whose incision is closed with the standard suture (vicryl). The primary outcome is quantification of blood loss (QBL). Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following delivery.
Study participation will last 1 year and will include the following research procedures :
- Randomization to barbed suture vs. standard suture
- Collection of data for primary and secondary outcomes
- Telephone survey 2 weeks following the procedure to assess pain, bowel/bladder habits, and evidence of wound infection. The barbed suture is approved by the FDA for use in soft tissue approximation and this is not an off-label usage.
详细描述
This is a prospective, randomized controlled trial (RCT) evaluating whether using a barbed suture to close a C-section incision can reduce blood loss. Patients undergoing C-section will be randomized with equal allocation to a barbed suture or a standard antimicrobial suture. The primary outcome is quantification of blood loss (QBL). Differences between the groups will be assessed using a 0.05 level Wilcoxon rank-sum test. Secondary outcomes include time for hysterotomy closure, need for additional hemostatic sutures, rate of endometritis/SSI (superficial wound infection, deep wound infection, and endometritis) within 6 weeks postpartum, use of hemostatic agents, and differences in pain which will be assessed by a telephone screening in the days following 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 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing a scheduled primary cesarean section at Mount Sinai Hospital
- •age 18-64.
排除标准
- •Multifetal gestations
- •Placenta previas
- •Pre-term patients
- •Patients with prior uterine incisions or a coagulopathy (DIC, Von Willebrands Disease, etc)
- •Patients undergoing an unplanned or emergency cesarean section
研究组 & 干预措施
Standard suture
Standard antimicrobial suture (vicryl) - control arm
干预措施: Standard antimicrobial suture (Procedure)
Barbed suture
Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue
干预措施: Barbed suture (Device)
结局指标
主要结局
Quantitative Blood Loss
时间窗: Day 1, At delivery
Quantification of blood loss (QBL)
次要结局
- Number of Participants Who Need Additional Hemostatic Sutures(Day 1, At delivery)
- Number of Hemostatic Sutures(Day 1, At delivery)
- Rate of Surgical Site Infections (SSI)(6 weeks)
- Time for Hysterotomy Closure(Day 1, At delivery)
- Number of Participants With Surgical Site Infections (SSI)(Day 1, At delivery)
- Change in Pain Score(Day 1, At delivery and 2 weeks)
研究者
Calvin Lambert
Assistant Professor-MSH/MSQ/QHC/SSVS/ELM OBGYN FACULTY - ISM
Icahn School of Medicine at Mount Sinai