Barrier-Protect Study: Do Barrier Dressings Reduce Device Infection: a Pilot, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 390
- 试验地点
- 2
- 主要终点
- End of surgery pocket swab culture positivity
研究概览
简要总结
This study will evaluate the effect of an iodine impregnated barrier dressing on device pocket swab culture positivity. Minimizing contamination during the implant procedure can be one of the potential improvements to prevent CIED infections. Patients requiring a lead change, battery change or device upgrade will be eligible. This is a randomized, blinded study where participants will be randomized to having the barrier dressing applied before any incision is made (experimental group) or applying the dressing just prior to collecting the culture swab (control group). Patients and the staff taking the culture swab at the end of the procedure are blinded as to which group the participant is randomized to.
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
- Double (Participant, Care Provider)
盲法说明
Participants and staff taking the swab will be blinded as to the randomization allocation.
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 aged 18
- •Second or later procedure (including pulse generator change, lead revision and device upgrade procedures) involving manipulation of the pre-existing device pocket.
- •PADIT risk score ≥ 5
排除标准
- •Unable or unwilling to provide informed consent.
- •De novo device implantation.
- •Active device infection.
- •Iodine allergy
- •Life expectancy less than 2 years
结局指标
主要结局
End of surgery pocket swab culture positivity
时间窗: one month post procedure
To investigate end of procedure pocket swab culture positivity as a potential surrogate marker of device infection
次要结局
- CIED infection, defined as in the recent PADIT trial(Year 1 and 2 post procedure)