Mass Continuous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- healing time, d (day)
研究概览
简要总结
A better suture technology will reduce postoperative incision complications. This study is designed to compare mass continous suture with PDS and interrupted suture with thread on major abdominal incision.
详细描述
A better suture technology will reduce postoperative incision complications. The previous retrospective cohort study from the investigator has demonstrated that continuous mass suture with PDS led to shorter incision closure time, early wound healing and comparable incisional complications versus interrupted thread suture. As such, the current RCT study will include 100 subjects with major abdominal incision. They will be divided into two groups randomly: Mass suture gorup, mass continuous suture with PDS, Control group, interrupted suture with thread. The wound healing time, stitches removal time and incidence of incision complications will be compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patient with major abdominal incision.
- •the incision is longer than 10 cm
- •aged between 18 to 65 years old
排除标准
- •Pregnant woman
- •Patient with diabetes
- •Patient with a history of cardiovascular disease, including coronary heart disease and stroke.
- •Severe lung diseases such as COPD and asthma
- •Patients undergoing emergent or infectious surgery
- •Patients with surgical site infection
- •No autonomy, inability or unwillingness to participate in follow-up
结局指标
主要结局
healing time, d (day)
时间窗: Up to 1 month after surgery
Time duration between the date of surgery to the date of stitches off
次要结局
- incidence of incision complications(Up to 1 month after surgery)
研究者
Zhang Xu-Feng
Professor
First Affiliated Hospital Xi'an Jiaotong University