Impact of Pocket Revision on the Rate of Infection and Other Complications in Patients Requiring Pocket Manipulation for Generator Replacement and/or Lead Replacement or Revision: A Prospective Randomized Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 265
- 试验地点
- 2
- 主要终点
- Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever
研究概览
简要总结
To determine the effect of scar tissue removal on the rate of infection and any other complications such as bleeding in patients with an ICD or pacemaker who have the device generator or leads replaced or repositioned.
详细描述
This is a randomized, prospective, single-blind study that evaluates the effect of removal of scar tissue during pacemaker/ICD pocket revision on infection and complications. Subjects will be randomly assigned to either removal of the scar tissue surrounding the implanted device during device replacement or to device replacement without removal of this tissue. Subjects will be followed for one year post-procedure for the occurrence of infection, bleeding/hematoma, or other complications.
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
- •Age 18 years or greater
- •Willingness to provide written informed consent
- •Subjects presenting for any of the following:
- •pacemaker/ICD generator change
- •pacemaker/ICD lead replacement
- •pacemaker/ICD lead revision
- •pacemaker/ICD upgrades
排除标准
- •Age less than 18 years
- •Unwillingness to provide written informed consent
- •Subjects unable to give consent
- •Pregnant or nursing women
- •Patients who have undergone pocket revision or manipulation less than 365 days prior
- •Patients who have undergone pacemaker or ICD implantation less than 365 days prior
结局指标
主要结局
Oral temperature, edema/redness/drainage and/or severity of pain at incision site, presence of chills, reported fever
时间窗: 1 year
次要结局
- If primary outcome measures are positive, blood and/or device cultures and lab work may be obtained(1 year)
研究者
Dhanunjaya Lakkireddy, MD, FACC
Associate Professor of Medicine
University of Kansas Medical Center