NCT05318430Unknown2 期
Subcutaneous Closed-Suction Drainage Affects Surgical Wounds Healing in Lower Gastrointestinal Open Surgery: a Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Rate of poor healing of incisions
研究概览
简要总结
This is a single-center, randomized controlled trial to evaluate whether subcutaneous closed-suction drainage would decrease the incidence of poor surgical site healing in lower gastrointestinal open surgery. The independent risk factors of the incidence of poor surgical wounds healing in lower gastrointestinal open surgery will be analyzed.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-85 years old, male or female
- •all patients underwent lower gastrointestinal surgery: the digestive tract below Treitz ligament was called lower gastrointestinal tract, including jejunum, ileum, ileocecal part and colorectal
- •open surgery (instead of laparoscopic) required
- •willing participated in clinical verification and signed informed consent.
排除标准
- •laparoscopic surgery
- •upper gastrointestinal surgery (esophagus, stomach, duodenum and hepatobiliary pancreas)
- •simple appendectomy / total appendectomy
- •hernia surgery and intestinal obstruction surgery without intestinal resection
- •infection of incision site before operation
- •pregnant women
- •expected death within 1 month after operation.
研究组 & 干预措施
Experimental group
Experimental
the closed-suction drainage device will be placed subcutaneously when closing the incision
干预措施: Subcutaneous closed-suction drainage device (Device)
Control group
No Intervention
the closed-suction drainage device will not be placed subcutaneously when closing the incision
结局指标
主要结局
Rate of poor healing of incisions
时间窗: Within 30 days after surgery
次要结局
未报告次要终点
研究者
Zhongtao Zhang
Director
Beijing Friendship Hospital
研究点 (1)
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