Prevention of the Risk of Complete Sternotomy Scar Dehiscence in Cardiac Surgery: A Randomized, Open-label Multicenter Clinical Investigation Comparing Negative Pressure Wound Therapy (NPWT) vs. Standard Dressing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 10
- 主要终点
- Complete median sternotomy wound cutaneous dehiscence
研究概览
简要总结
Mediastinitis is the most feared infectious complication after cardiac surgery. Several risk factors are known such as: obesity, diabetes, chronic obstructive pulmonary disease, double breast sampling, immunodeficiency, corticosteroid therapy, reoperation, chest radiotherapy, and dialysis. Three modes of contamination are described: intraoperative contamination, hematogenous dissemination during sepsis, gradual contamination from cutaneous dehiscence. It is important and simple to fight against this third mode. The dehiscence of the sternotomy scar represents a gateway and facilitates bacterial colonization and is a risk factor for infection of the surgical site. These skin disunities lead to an increase in health care costs due to extension of hospital stay, the cost of repeated nursing care, surgical revision, and the need for increased follow-up. They delay cardiac rehabilitation and return home. It is estimated that these simple disunities occur in more than 15% of cases, although fortunately they rarely result in mediastinitis. While the use of NPWT for the prevention of wound healing complications is permitted, its benefit has not been demonstrated. Its action is multiple with a reduction in the rate of repair of dressings and therefore of soiling, drainage of the wound, limitation of maceration, acceleration of healing. The use of NPWT as a dressing for sternotomies could prevent skin breakdown, and therefore superficial and deep surgical site infections.
Two types of NPWT devices exist, corresponding to 2 different types of treatment: the 7-day NPWT without dressing repair but with reservoir (PREVENA®), the NPWT with 3-day repair without reservoir (PICO®).
Given the cost and widespread use of NPWT for chirurgical site infection prophylaxis, it is important to conduct randomized trials to assess the expected benefit of these NPWTs designed for use on clean, closed surgical incisions. In cardiac surgery, its benefit has only been shown in a high-risk population: surgery for Coronary Artery Bypass Graft (CABG).
The present clinical investigation will be the first randomized, multicenter trial comparing the efficacy and safety of NPWT versus standard dressing in preventing the risk of scar dehiscence after cardiac surgery, in a standard population.
The patients will be followed for 90 days (3 months).
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
- 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
- •All patients undergoing scheduled or semi-urgent cardiac surgery, with or without extracorporeal circulation.
- •Patients managed by complete vertical median sternotomy.
- •Patients benefiting from a Social Security scheme or benefiting from it through a third party.
- •Informed consent signed by the patient after clear and complete information about the clinical investigation.
- •All patients included in this clinical investigation must not have any of the non-inclusion criteria listed below:
排除标准
- •Known allergy to one of the dressings: PREVENA®, PICO® or standard dressing
- •Patient with a contraindication to PICO® dressing
- •Patient with a contraindication to PREVENA® dressing:
- •Sensitivity to silver
- •Patient with a history of cardiac surgery prior to inclusion
- •Patient with skin infection (folliculitis) of the sternotomy site before the operation.
- •Urgency and extreme urgency (patient operated within 24 hours of admission).
- •Patient already participating in a clinical investigation whose main objective or secondary objectives are likely to have an impact on the main objective of this clinical investigation
- •Patient with antibiotherapy ongoing (endocarditis patients)
- •Minimal sternotomy (8-10 cm)
- •Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy), or having a positive pregnancy test at inclusion
- •The inability of the patient to complete informed consent before any study procedure
- •Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection
结局指标
主要结局
Complete median sternotomy wound cutaneous dehiscence
时间窗: 30 postoperative days
Complete median sternotomy wound cutaneous dehiscence in cardiac surgery during the first 30 postoperative days will be assessed by tablet calibrated photos analyzed by an independent blinded staff.
次要结局
- The number of dressing repairs(Between 7 and 90 postoperative days)
- The length of initial hospital stay(Between 7 and 90 postoperative days)
- The number of dressing repairs(Between 7 and 90 postoperative days)
- The use of an anti-infectious treatment and its duration.(Between 7 and 90 postoperative days)
- The incidence of postoperative mediastinitis defined by dehiscence of the sternum with positive sternal samples.(At Day 90)
- The length of initial hospital stay(Between 7 and 90 postoperative days)
- The occurrence of an infection of the surgical site and its classification(At Day 90)
- The nurse's satisfaction with the use of the 3 types of dressing during dressing repair by means of a standardized questionnaire.(7 postoperative days)
- The incidence of surgical revision for dehiscence of the surgical wound at D90.(At Day 90)
- The number of rehospitalizations (including consultations), and their duration.(At Day 90)
- The surgeon's satisfaction with the wound by means of a standardized questionnaire.(7 postoperative days)
- The incremental cost-utility ratio expressed in costs per quality-adjusted life-year (QALY) gained.(Between 7 and 90 postoperative days)
- The incremental cost-effectiveness ratio expressed in costs per post-operative complication avoided(Between 7 and 90 postoperative days)