A Randomized Phase III Trial to Compare the Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication for Mesothelioma or Other Pathologies
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Time to Resolve Air Lung Leak After Pleurectomy Decortication
研究概览
简要总结
The goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for preventing air leaks in patients having a pleurectomy decortication.
详细描述
If participant agrees to take part in this study, they will have their pleurectomy decortication as planned. Participant will sign a separate consent for this procedure that explains the risks.
At the time of participant's surgery, sutures and staples are used to help correct air leaks, which is standard.
Then, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group:
- One group will have Progel® added to the surface of the lung before closing the chest.
- The other group will have talcum powder added to the surface of the lung before closing the chest.
Participant will have an equal chance of being in either group.
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
- Double (Participant, Investigator)
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
- •All patients with mesothelioma or other pathologies undergoing a pleurectomy decortication at MD Anderson Cancer Center
- •Adequate preoperative renal function documented by serum creatinine of < 1.5 mg/dl or calculated creatinine clearance > 50 ml/min
排除标准
- •Patients unable to consent for the procedure
- •Patients with a history of allergy to human proteins
- •Patients who may have insufficient renal capacity for clearance of Progel® polyethylene glycol load
结局指标
主要结局
Time to Resolve Air Lung Leak After Pleurectomy Decortication
时间窗: Participants followed for the duration of hospital stay, at least 5 days.
Primary outcome is T = time to resolve an air leak in the lungs, allowing the possibility that an air leak may not develop, represented by T=0.
次要结局
未报告次要终点