Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sternal Alignment
研究概览
简要总结
This will be a prospective, randomized clinical trial, comparing the sternal alignment between the fixation with rigid plate X steel wires. Patients over 18 years of age, belonging to the lung transplant line in the State of São Paulo, who will undergo bilateral lung transplantation will be studied.
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
- 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
- •Above 18 years of age;
- •Belonging to the transplant queue of InCor;
- •Eligible for sequential bilateral lung transplantation submitted to clamshell incision;
排除标准
- •Patients undergoing a new surgical procedure after lung transplantation with the need to manipulate the steel wires or the sternal fixation plate other than for osteomyelitis;
- •Intraoperative death;
- •Patients who have undergone unilateral lung transplantation or have not undergone a clamshell incision.
研究组 & 干预措施
SW
Patients undergoing sternal closure with steel wires
干预措施: Rigid plate X steel wires (Device)
RP
Patients undergoing sternal closure with a rigid plate
干预措施: Rigid plate X steel wires (Device)
结局指标
主要结局
Sternal Alignment
时间窗: 6 months
Sternal alignment will be analyzed through cross-sections of chest computed tomography by a certified radiologist. Two parameters will be used for sternal alignment: Misalignment: 1. Significant:\> 3mm; 2. Non-significant: ≤3mm Deviation: 1. Grade 1: ≤50% 2. Grade 2:\> 50%
Sternal Alignment
时间窗: 1 month
Sternal alignment will be analyzed through cross-sections of chest computed tomography by a certified radiologist. Two parameters will be used for sternal alignment: Misalignment: 1. Significant:\> 3mm; 2. Non-significant: ≤3mm Deviation: 1. Grade 1: ≤50% 2. Grade 2:\> 50%
Sternal Alignment
时间窗: 3 months
Sternal alignment will be analyzed through cross-sections of chest computed tomography by a certified radiologist. Two parameters will be used for sternal alignment: Misalignment: 1. Significant:\> 3mm; 2. Non-significant: ≤3mm Deviation: 1. Grade 1: ≤50% 2. Grade 2:\> 50%
次要结局
- Bone healing(6 months)
- Time to close the Rib cage(6 months)
- Pain(6 months)
- Bone healing(1 month)
- Bone healing(3 months)
- Pain(1 month)
- Pain(3 months)
- Time to close the Rib cage(1 month)
- Time to close the Rib cage(3 months)
研究者
Paulo Manuel Pêgo Fernandes
Principal Investigator
University of Sao Paulo General Hospital