10 Versus 20 Minutes Treatment of Human Pericardium With Glutaraldehyde in OZAKI Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- mechanic stability tests to investigate uniaxial and cyclical tensile properties
研究概览
简要总结
To compare mechanic and thermic stability of pericardium fixated either with 0.6% glutaraldehyde for 10 minutes or with 0.6% glutaraldehyde for 20 minutes
详细描述
Autologous pericardium for aortic valve reconstruction is treated with 0.6% glutaraldehyde for 10 minutes to improve stability (OKAZI technique).
This study investigates whether treatment with 0.6% glutaraldehyde for 20 minutes improves mechanic and thermic stability of autologous pericardial tissue. Autologous pericardium remaining after aortic valve reconstruction surgery is used.
To investigate 10 versus 20 minutes treatment of removed original aortic valve tissue with glutaraldehyde as a reference.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing aortic valve surgery with sufficient leftover tissues from the OZAKI procedure (excess of pericardium and calcified aortic valve leaflets)
排除标准
- •denial of consent
- •insufficient leftover tissues from the OZAKI procedure
- •patients after thoracic radiation or surgery
结局指标
主要结局
mechanic stability tests to investigate uniaxial and cyclical tensile properties
时间窗: 4 days after surgery
mechanical tests include the use of a universal test machine (MTS Bionix, Department of Bioengineering of Universitaetsspital Basel) for: * uniaxial ultimate tensile strength (UTS) test; * cyclical tensile stretching of the tissue in order to investigate its viscoelastic properties
thermic stability by using constant force at linearly increasing temperature
时间窗: 4 days after surgery
constant force at linearly increasing temperature: Thermal stability tests will be conducted on 20 x 4 mm stripes by the imposition of a constant load (approximately 1N) submerged in a saline-solution bath. The temperature of the bath will be increased at a rate of approximately 2.5-5 °C/min, and the sample cross-section will be measured by means of a high-resolution camera (Canon EOS, Japan)
次要结局
- Pronase testing to analyse enzymatic degradation(4 days after surgery)
- histologic analysis of collagen fiber organization and quantification(4 days after surgery)