A Randomized Pilot Trial of Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With Postoperative Intra-abdominal Abscess
研究概览
简要总结
The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis. Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal irrigation.
详细描述
Postoperative intra-abdominal abscesses are common occurrences after perforated appendicitis in pediatric patients despite utilization of evidence-based practices. Povidone-iodine is a commonly used antiseptic in surgical procedures and has been shown to be effective in reducing postoperative abscesses in adults with perforated appendicitis. This trial will be the first to rigorously test the efficacy of povidone-iodine irrigation in children and to verify its safety profile in this patient population.
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
- Single (Participant)
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
- •Children who undergo an appendectomy for perforated appendicitis. (Appendicitis: Diagnosis is made intraoperatively by the surgeon. Diagnosis Method: The visualization of a gross defect in the appendiceal wall or the presence of intraperitoneal stool or a fecalith at the time of operation.)
排除标准
- •Patients presenting with simple or gangrenous appendicitis
- •Patients with a history of iodine sensitivity, thyroid disease or renal disease
- •Patients undergoing interval or incidental appendectomy
- •Patients/parents/legal guardians who are both non-English and non-Spanish speaking
研究组 & 干预措施
Povidone-iodine irrigation
干预措施: Povidone-iodine irrigation (Drug)
No irrigation
干预措施: No irrigation (Procedure)
结局指标
主要结局
Number of Participants With Postoperative Intra-abdominal Abscess
时间窗: 30 days post surgery
30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol
次要结局
- Total Hospital Length of Stay(30 days post surgery)
- Number of Participants Who Were Readmitted to the Hospital(30 days post surgery)
- Number of Participants Who Visited the Emergency Room(30 days post surgery)
研究者
KuoJen Tsao
Associate Professor
The University of Texas Health Science Center, Houston