The Use of PrevenaTM Incision Management System on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 342
- 试验地点
- 25
- 主要终点
- Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.
研究概览
简要总结
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy). The subjects targetted for the study are at high risk for surgical complications (like infections) around the environment of the incision.
The study is conducted in The Netherlands, Germany and Austria.
详细描述
The Prevena™ IMS is intended to manage the environment of closed surgically incision and surrounding intact skin for patients with an increased risk for developing post-operative complications such as infection.The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy). The subjects targetted for the study are at high risk for surgical complications (like infections) around the environment of the incision.
The Prevena™ IMS is a small portable device, which consists of a mild vacuum unit that delivers negative pressure and a dressing that is intended for use over closed incisions after surgery. It is used for a minimum of 4 days up to a maximum of 7 days. This system is commercially available and has a CE mark, which means that it is approved for the use on the European market. It is intended to be applied immediately post sternotomy surgery on a closed clean incision.
The results of this study could contribute to a better and faster healing of the incision.
The study is conducted in The Netherlands, Germany and Austria.
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
- •Is male or female and 18 years of age or older
- •Is scheduled for elective cardiac surgery for which a median sternotomy is needed (including coronary artery bypass grafting (CABG), valvular repair or replacement with or without CABG). Elective surgery is defined as planned surgery a minimum of 24 hours before the procedure.
- •Is capable of providing informed consent, which must be obtained prior to any study-related procedures
- •Is willing and able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •Is pregnant
- •The use of Prevena post surgery is contra indicated per investigator's discretion
- •Has a systemic infection at the time of surgery: systemic infection is diagnosed on the basis of clinical signs of sepsis with or without a positive culture of an organism from the bloodstream
- •Has a remote body site infection at the time of surgery (including dental, urinary or skin soft tissue infections)
- •Is known to have a current nasal swab positive for methicillin-resistant staphylococcus aureus (MRSA)
- •Has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
- •Has a requirement for competing wound therapy and procedures.
- •Any concomitant therapies (including other NPWT treatment) or procedures deviating from the clinical standard incision treatment or with investigational device at the location of the sternotomy (e.g. use of NPWT at other location of the body is allowed)
- •Any other therapies or procedures that, in the opinion of the treating physician, would affect or influence postoperative wound stability or healing
- •Is simultaneously participating in another interventional trial
- •Requires use of liquid skin adhesives or glues during skin closure
- •Is known to be serology positive for hepatitis B, hepatitis C or HIV
结局指标
主要结局
Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.
时间窗: 30 ± 4 days
The SSI rate (in %) was calculated for each treatment arm as follows: SSI rate = \[Number of Subjects who experienced SSI\] / \[Number of Subjects Analyzed\] \* 100 Subjects included in the numerator for the SSI rate computation must have experienced an SSI post-surgery up to Day 30 (± 4 days). If a subject has the same SSI event on multiple occasions or experiences several events of other SSIs, the subject will be counted only once in the numerator for the first event
次要结局
未报告次要终点