NPWTi vs. Conventional NPWT in Superficial and Deep Abdominal Surgical Site Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 30-day recurrence rate
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of NPWTi and NPWT in superficial and deep surgical site infections using an improvised system with continuous lavage with saline and chlorhexidine. The main question it aims to answer is whether the NPWTi is better than conventional NPWT. Participants will be given NPWTi or conventional NPWT.
Researchers will compare the two groups to see if NPWTi diminishes the rate of recurrent infections and the number of reoperations, shortens the hospital stay, and alleviates the burden on the hospital staff in comparison to the conventional NPWT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults over 18 years
- •superficial or deep SSIs after laparotomy or laparoscopic surgery
排除标准
- •persons < 18 years
- •documented inherited or acquired coagulation disorders or platelet deficiency
- •presence of deep space infection (intra-abdominal abscess or ongoing peritonitis)
- •prosthetic material infection
结局指标
主要结局
30-day recurrence rate
时间窗: 30 days after discharge
30-day recurrence rate of the infection
eradication of the infection
时间窗: 6 weeks
(negative microbiology or bacterial count \< 103)
the rate of wound closure
时间窗: 6 weeks
the wound closure by suture or flap
次要结局
- time to wound closure(6 weeks)
- hospital stay(6 weeks)
- number of OR visits(6 weeks)