Phase 1 Study of Prevention of Cardiac Device Implantation Site Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- freedom of cardiac device-related infection
研究概览
简要总结
Cardiovascular implantable electronic device (CIED) infections have been increasing out of proportion to the number of devices implanted We investigated recent trends and possible causes of the increasing numbers of Cardiovascular implantable electronic device infections.
详细描述
There are many studies on the preventive use of Antibiotics or povidone iodine to Cardiovascular implantable electronic device (CIED) infections.
But, studies of prophylactic use of hydrogen peroxide is still limited.
We had planned research on effects of preventive using hydrogen peroxide before cardiac devices insertion.
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
- Single (Participant)
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
- •scheduled for cardiac devices Implantation
排除标准
- •under the age of 18
- •Hydrogen peroxide allergy
- •take an antibiotic
- •History of infection within 30 days
研究组 & 干预措施
Hydrogen peroxide pretreatment group
Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.
干预措施: Hydrogen peroxide pretreatment group (Procedure)
Control group
No intervention group
结局指标
主要结局
freedom of cardiac device-related infection
时间窗: 1 year after precedure
check the symptoms of infection. If have symptoms of infection : check the fever, heart rate, respiration rate, blood test, EKG
次要结局
未报告次要终点
研究者
Yong Seog Oh
ph.D
Seoul St. Mary's Hospital