ACTRN12622001422718尚未招募未知
An Investigator Led Trial to Assess the Safety and Efficacy of the Waston Sternal Claw Fixation System against Standard of Care Wire Cerclage as an Advantageous Method of Median Sternotomy Closure
Professor Jayme Bennetts0 个研究点目标入组 90 人开始时间: 2022年11月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Patients who undergo median sternotomy for any cardiac procedure
- •-Patients aged 18-80
- •-Patients who have sufficient English language
- •-Patients able to and willing to comply with all study procedures
- •-Patient able to understand and provide informed consent
排除标准
- •-Patients allergic to heavy alloy
- •-Patients undergoing re-do procedure
- •-Patients who have chronic steroid or narcotic use
- •-Patients with a clinical sternal deformity
- •-Pregnant women
- •-Patients with a body mass index greater than or equal to 40
- •-Patients with severe chronic obstructive airway disease
- •-Patients with dialysis dependent renal failure.
- •-Patients who have any of the following Sternal Claw contraindications:
- •oSevere mental disorder
- •oGeneralized nervous disease
- •oImmune suppression disorder
- •oCalcified tissue metabolism disorder
- •oSystematic or local infections
- •oAllergic to metal materials
- •Intra-Operative criteria
- •-Any intra-operative condition that would preclude the use of the Sternal Claw as deemed appropriate by the treating surgeon
- •opoor bone quality
- •oparamedian (non midline) sternotomy
- •obleeding (or high likelihood of depending on case specific issues)
- •oSizing/technical suitability for CLAW plating system or concerns around use of routine sternal wires
- •oOther surgical complications as assessed by operating surgeon
研究者
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