Phase 1 Study of Prevention of Cardiac Device Replacement Site Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 352
- 试验地点
- 2
- 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 the investigators 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 posterior pocket capsule removal is still limited.
The investigators had planned research on effects of posterior pocket capsule removal before cardiac devices replacement.
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
- 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 replacement
排除标准
- •under the age of 18
- •take an antibiotic
- •history of infection within 30 days
研究组 & 干预措施
device replacement
remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze
干预措施: device replacement(pocket capsule removal) (Procedure)
control group
remove previously inserted cardiac device and the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze
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
- freedom of endocarditis(1 year after precedure)
研究者
Yong Seog Oh
Ph.D
Seoul St. Mary's Hospital