Reducing Surgical Site Infection Rates Using an Alternative Sternal Dressing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- Rates of surgical site infection pertaining to each dressing studied.
研究概览
简要总结
This study will evaluate two alternative dressings compared to a standard Island dressing presently in use at Stanford Hospital to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients. Cardiovascular surgery patients who will have a sternotomy incision as a routine part of their surgery will be approached to voluntarily participate. Participants will be randomized to one of three dressing to determine which dressing has the lowest rate of sternal wound infection. The investigators will also assess the impact of alternative dressing use on hospital 30-day readmission rates related to SSI.
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
- 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
- •Participants who will undergo cardiac surgery via a sternotomy incision.Inclusion criteria will be patients having surgical valve, CABGs, aortic dissection, myectomy and myotomy, Cox MAZE, Myocardial bridge Un-roofing
排除标准
- •Patients undergoing heart transplants, Ventricular Assist Device (VAD), with postoperative courses complicated by tamponade, take-backs, and open chest incisions will also be excluded.
研究组 & 干预措施
Dressing 1: Standard Island Dressing
Standard dressing that is applied on most patients with a sternotomy wound incision immediately after cardiovascular surgery before leaving the operating room. Dressing will be removed 48 hours after surgery.
干预措施: Standard Island Dressing (Device)
Dressing 2: Prevena negative pressure
Prevena negative pressure wound suction machine dressing applied to sternotomy wound incision immediately after cardiovascular surgery. Dressing will be in use for 7 days or removed sooner if participant is discharged before end of 7 day post-operative time period.
干预措施: Prevena Negative Pressure wound dressing (Device)
Dressing 3: Mepilex Border Post-Op Ag
Mepilex Border PostOp AG dressing impregnated with silver ions. Dressing will be in use for 7 days or removed earlier if patient is discharged before end of 7 days post0operative time period.
干预措施: Mepilex Border Post-Op Ag (Device)
结局指标
主要结局
Rates of surgical site infection pertaining to each dressing studied.
时间窗: From Post-Operative date 0 to 7th day or earlier which ever day comes first.
evaluate alternative dressings to determine reductions in surgical site infection (SSI) rates among cardiac surgery patients
次要结局
- Impact of alternative dressings on rates of Sternal wound incision infection(30 days after participant discharge.)
研究者
Jack Boyd
Prinicipal Investigator
Stanford University