NCT05599841Unknown不适用
Evaluation of the Systemic Effect of Intraoperative Diluted Povidone Iodine Irrigation Using Urine Iodine and Thyroid Function Tests in Patients Undergoing Knee-Hip Arthroplasty
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Urine iodine level
研究概览
简要总结
Povidone iodine (PI) solution is an antimicrobial solution that can be used at hip and knee arthroplasty cases. It contains iodine that may be absorbed by the body. This study aims to investigate any absorption caused by PI solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
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
- •All patients with hip/knee osteoarthritis who undergo primary arthroplasty
排除标准
- •Patients with abnormal thyroid function tests in the preoperative period, a history of the previous thyroid-related disease.
研究组 & 干预措施
Povidone Iodine Solution
Active Comparator
The group whom PI solution will be used at surgery
干预措施: PI solution (Procedure)
Saline Solution
Placebo Comparator
The group whom only saline solution will be used at surgery
干预措施: Saline Solution (Procedure)
结局指标
主要结局
Urine iodine level
时间窗: postoperative first day
Urine iodine concentration
次要结局
- Thyroid hormone(postoperative 14 days)
研究者
Hakan KOCAOGLU
M.D. Assoc. Prof.
Ankara University
研究点 (1)
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