NCT05434260Enrolling By Invitation不适用
The Use of Povidone-iodine Sterile Solution to Reduce Periprosthetic Joint Infections: a Superiority Multicentre Randomized Trial
Center for Innovation and Research Organization8 个研究点 分布在 1 个国家目标入组 868 人开始时间: 2022年9月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 868
- 试验地点
- 8
- 主要终点
- Diagnosis of acute prosthetic joint infection
研究概览
简要总结
This study will be an open-label superiority, multicenter, single-blind, controlled randomized clinical trial investing the role of a PVP-I irrigation solution (Surgiphor) in reducing the risk of acute PJI in the 90 days following total hip and knee revision arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patient ≥18 years old
- •Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
- •Subjects scheduled to undergo total knee or total hip revision for aseptic reasons (per 2018 ICM criteria 5)
- •Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. Subjects not willing to sign consent form to be randomized must be willing to sign alternate consent form to allow prospective data collection in the non-randomized arm of the study
排除标准
- •Subjects with known allergies to iodine or any other ingredients in Surgiphor
- •Subjects unwilling to sign informed consent
- •Subjects, for health reasons or other, in the opinion of the Investigator, with a life expectancy less than one year, which is the follow-up period of the study
结局指标
主要结局
Diagnosis of acute prosthetic joint infection
时间窗: Within 90 days of revision surgery
Diagnosis of acute prothetic joint infection following aseptic revision surgery
次要结局
- Wound complications(within 1 year of revision surgery)
研究者
研究点 (8)
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