NCT07251881招募中不适用
Prospective-randomized Trial to Demonstrate Superiority of SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Sternal bone healing
研究概览
简要总结
During certain heart surgeries, the sternum is opened and must then be closed securely. The study compares two closure methods - steel wires and SuperCable - in terms of stability, healing, and patient satisfaction. This investigation aims to demonstrate that the iso-elastic properties of the SuperCable Sternal Closure System result in faster sternal bone healing, reduced postoperative pain, shorter hospital stay, and improved physical recovery compared to conventional steel wire sternal closure. Eighty-six patients are participating and are randomly assigned to one of the two groups. After the operation, pain, healing, and possible complications are checked. The patients are examined 3 and 6 months after the operation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Provision of Informed Consent: The subject must have signed and dated the informed consent form prior to any study-related procedures.
- •Willingness and Ability to Comply: The subject must express a stated willingness to comply with all study procedures and be available for the duration of the study.
- •Age and Sex:
- •Age: The subject must be at least 18 years old.
- •Sex: Both male and female subjects are eligible. In line with the "Sex and Gender in Research Involving Humans" recommendations, data will be stratified and analyzed by sex to identify any potential differences in outcomes.
- •Language Competence: The subject must possess sufficient German language skills to accurately complete the postoperative survey
- •Travel Capability: The subject must have the ability to travel for all planned study visits, including scheduled CT scans
- •Surgical Procedure: The subject must be scheduled for elective coronary artery bypass graft (CABG) procedures, as this is the focus of the investigation
- •Adherence to Visit Schedule: The subject must be willing to adhere to all scheduled visits and undergo CT scans as outlined in the study protocol
排除标准
- •Pharmacological Restrictions: Current use of corticosteroids or any immunosuppressive medication
- •Prior Treatments and Therapies: History of radiation therapy to the thorax
- •Reproductive Considerations:
- •Pregnancy, or the intent to become pregnant during the study period
- •Lactation or current breastfeeding
- •Allergic Reactions: Known allergic reactions to components of the conventional steel wire or SuperCable, specifically any known metal allergies (e.g., nickel or titanium).
- •Example: Patients with a documented history of nickel allergy, including previous adverse reactions to products such as sternal cerclages, will be excluded
- •Infectious or Febrile Conditions: Any febrile illness occurring immediately before the scheduled surgery
- •Concurrent Investigational Treatments: Treatment with another investigational drug or medical device within two months preceding surgery, as well as during the current investigation
- •Surgical History: Subjects who have undergone prior sternotomy and osteosynthesis (i.e., re-do patients) will be excluded
- •Anatomical Considerations:
- •Known sternal deformities that could compromise the outcome of the investigation
- •Off-midline sternotomy approaches, as these do not align with the surgical technique under investigation
- •Patient Residence and Follow-Up Feasibility: Subjects residing in remote regions, including those from interstate or overseas, where follow-up and adherence to the scheduled visits might be compromised
- •Other Specific Exclusions: Any additional criteria specific to the disease under investigation or identified by the investigator based on medical judgment (e.g., clinically significant concomitant disease states such as renal failure, hepatic dysfunction, or cardiovascular disease, if these conditions are deemed to interfere with study outcomes)
研究组 & 干预措施
SuperCable®
Experimental
In the intervention group, sternal closure is performed using the SuperCable® Sternotomy Closure System.
干预措施: SuperCable® (Device)
Steel wires
Active Comparator
In the control group, sternal closure is performed using conventional USP 7 (United States Pharmacopeia size-designation system) tool steel wires.
干预措施: Steel Wires (Device)
结局指标
主要结局
Sternal bone healing
时间窗: day5, day90, day180 (might be waived depending on outcome on day90)
Sternal bone healing, assessed via multiplanar CT-scans and a validated quantitative scoring algorithm (Stacy et al., 2014).
次要结局
- Length of Hospital Stay(day90 (Visit 3))
- Postoperative pain assessed by using a 10-point visual analog scale (VAS)(day1, day5, day90, day180)
- Total use of opioid-like drugs(day1, day5, day90, day180)
- Upper Extremity Functional Index Score (UEFI)(day90, day180)
- Postoperative Quality of Recovery Scale (PostopQRS)(day90, day180)
- Functional Difficulty Questionnaire (FDQ)(day90, day180)
- Composite of all complications related to sternal osteosynthesis (i.e., sternal dehiscence, re-operation due to sternal wound healing, wound infections)(day1, day5, day90, day180)
- Assessment of sternal stability as determined by ultrasound measurement of sternal motion(day5, day90, day180)
研究者
研究点 (1)
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