The Use of PlCO-Vacuum-System on Sternal Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Infection at 30 POD
研究概览
简要总结
The use of a vacuum-assisted wound closure system (PICO, Fa. Smith & Nephew) is being investigated to determine whether it reduces the incidence of sternal wound healing disorders compared to conventional wound care with plaster.
详细描述
Median sternotomy remains the standard surgical approach for most cardiac surgeries. However, postoperative wound infections can occur and may progress to mediastinitis, a life-threatening complication with significant mortality. This risk is particularly pronounced in cases where sternal perfusion is compromised, such as when one or both internal mammary arteries are harvested during coronary artery bypass grafting. In such scenarios, the incidence of sternal wound healing disturbances is estimated to range from 2% to 7%.
Several strategies aim to reduce the risk of sternal wound infections. One approach involves external stabilization using a thoracic vest, which has been shown to significantly decrease sternal instability and healing disorders when implemented early in the postoperative period. Another approach utilizes negative pressure wound therapy, which has demonstrated efficacy in reducing sternal wound healing complications in prior studies involving systems like Prevena (Fa. KCI).
The PICO-System operates with a distinct vacuum pressure mechanism and a unique film design compared to the Prevena system. To date, no prospective randomized studies have evaluated the PICO-System for its effectiveness in reducing sternal healing disturbances, sternal instability, and mediastinitis. This study aims to compare conventional plaster wound care with the PICO vacuum system in a randomized, prospective design, assessing outcomes up to six months postoperatively.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing cardiac surgery by means of median sternotomy and exhibiting more than one of the following risk factors:
- •Diabetes mellitus (treated with oral antidiabetics and/or insulin)
- •LVEF<40%
- •Female gender
- •Adipositas (BMI > 30kg/m2)
- •History of myocardial infarction (NSTEMI or STEMI) within 14 days
- •Known peripheral arterial disease
- •Planned BIMA surgery.
排除标准
- •Planned hemisternotomy or anterolateral thoracotomy
- •Emergency cases
- •Lack of consent
- •Active therapy with immunosuppressants (including steroids)
研究组 & 干预措施
PICO arm
PICO vacuum system for post-sternotomy wound
干预措施: cardiac surgery via median sternotomy (Procedure)
Control arm
usual commercial wound dressing
干预措施: cardiac surgery via median sternotomy (Procedure)
结局指标
主要结局
Infection at 30 POD
时间窗: until day 30 post-surgery
Rate of superficial or deep sternal wound healing disorders at 30 days postoperatively
次要结局
- Infection at 180 Postoperative Days (POD)(Up to 180 days post-surgery)
- Patient satisfaction(until day 7 post-surgery)
