Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,750
- 试验地点
- 1
- 主要终点
- number of patients with post operative intra-abdominal abscesses
研究概览
简要总结
The purpose of this study is to determine the effect of intra-abdominal irrigation with povidone-iodine (PVI) versus usual care on the rate of 30-day postoperative intra-abdominal abscesses (IAA) and to determine the effect of PVI irrigation versus usual care on 30-day hospital length of stay(LOS) and 30-day readmissions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to a participating center
- •Appendectomy performed for acute appendicitis
- •Intraoperative diagnosis of perforated appendicitis
排除标准
- •Simple or gangrenous appendicitis
- •Interval or incidental appendectomy
- •Initial attempt at non-operative management (defined as >48 hours between the time of diagnosis and surgical intervention)
- •History of iodine allergy, thyroid disease or renal dysfunction
- •Pregnancy
研究组 & 干预措施
Irrigation with PVI
干预措施: Irrigation with PVI (Drug)
Usual care
干预措施: Usual care (Procedure)
结局指标
主要结局
number of patients with post operative intra-abdominal abscesses
时间窗: 30 days post surgery
An IAA will be defined as: an image-confirmed (ultrasound, CT, or MRI) fluid collection deemed to be an IAA by an attending radiologist or pediatric surgeon, or an abscess confirmed during percutaneous intervention (aspiration of purulent fluid) or reoperation (direct visualization of purulent fluid).
次要结局
- Length of hospital stay(LOS)(30 days post surgery)
- Number of patients that are readmitted(30 days post surgery)
研究者
KuoJen Tsao
Professor
The University of Texas Health Science Center, Houston