跳至主要内容
临床试验/NCT04317924
NCT04317924撤回不适用

Use of Polyglycolic Acid Felt for Air-leak Prevention After Lung Resection

Boston Medical Center2 个研究点 分布在 1 个国家开始时间: 2020年10月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Pneumostasis With Use of Bio-absorbable Mesh and... | 临床试验