Use of Polyglycolic Acid Felt for Air-leak Prevention After Lung Resection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to removal of chest tubes
研究概览
简要总结
Prolonged air leak, defined as air leak present 5 days after lung resection, is one of the most common complications after lung resection. This leads to patient discomfort (as the chest tube has to stay in place while air leak is present), prolonged stay, and increased cost.
NeoVeil is a bioabsorbable glycolic acid which has been used in Japan and other Asian countries for air leak prevention after lung resections. NeoVeil is impregnated with fibrin sealant materials and is placed on the lung surface at the time of operation. It then acts as a scaffold on resected area which is prone to air leak.
This randomized clinical trial will be the first in the United States to test its efficacy for air leak prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients undergoing elective lung resection at BMC
- •Intra-operative diagnosis of air leak
排除标准
- •Patients undergoing emergency lung resection
结局指标
主要结局
Time to removal of chest tubes
时间窗: 2 years
The time in hours to removal of chest tubes post lung resection will be abstracted from the electronic medical record of each participant.
次要结局
- Number of participants with additional interventions for air leak(2 years)
- Length of hospital stay(2 years)
