NCT01408745终止4 期
Multicenter Controlled Study on the Safety and Efficacy of Sternal Closure With STERNUMFIX in Patients With High Risk
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Aesculap AG
- 入组人数
- 166
- 试验地点
- 4
- 主要终点
- cumulative three-months incidence of re-operation rates due to sternal instability or infection for patients with SternumFix in comparison to sternal fixation with wires in a high risk patient population
研究概览
简要总结
The primary objective is to establish if the SternumFix System improves sternal closure. The study should test the hypothesis that in a high risk patient population with increased risk for the development of sternal wound complications SternumFix will reduce the incidence of sternal healing complications. The control group will be treated with wire cerclage, the standard method of sternal closure.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective cardiac surgery with a median sternotomy
- •Age >18 years
- •Male and female sex
- •Informed consent
- •Patients with high risk for sternal wound complications
- •Patients are designated as high risk patients if they have either:
- •one or more major risk factors or
- •four or more minor risk factors.
- •Major risk factors are:
- •Obesity: BMI >
- •Diabetes: intake of oral anti-diabetic drugs and/or insulin at time of surgery.
- •COPD: history of chronic coughing plus expectoration for at least 3 months by at least two consecutive years, plus evidence of restrictive pattern at spirometry.
- •Planned BITA: bilateral use of thoracic artery
- •Age > 75 years
- •Minor risk factors are:
- •History of smoking;(minimum of 1 year of history of smoking)
- •Hyperlipoproteinaemia (as stated in the patient data)
- •Planned surgery is a CABG
- •Patient is on dialysis
- •Repeat sternotomy
- •Left ventricular ejection fraction < 30% (as stated in the patient data)
排除标准
- •Active infection
- •Participation in a pharmaceutical clinical study or any trial with interfering endpoints within the last 30 days
- •Pregnancy
研究组 & 干预措施
Sternumfix
Experimental
sternotomy closure with Sternumfix
干预措施: Sternumfix (Device)
Steel wire
Active Comparator
sternotomy closure with steel wire
干预措施: steel wire (Procedure)
结局指标
主要结局
cumulative three-months incidence of re-operation rates due to sternal instability or infection for patients with SternumFix in comparison to sternal fixation with wires in a high risk patient population
时间窗: within three months
次要结局
- Adverse event rate. Postoperative chest pain. Length of postoperative hospital stay. Blood loss within the first 12 hours p.o. Duration of the sternal fixation.(within 3 months)
研究者
研究点 (4)
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