NCT03450265已完成不适用
A Randomized, Controlled, Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 14
- 主要终点
- Duration of postoperative air leakage
研究概览
简要总结
This study is a randomized, controlled study, with the primary objective to demonstrate non-inferiority of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection, and with the secondary objective of evaluating the safety of Hemopatch compared to TachoSil.
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
- •Preoperative-
- •Patients, 18 years or older at the time of signing the informed consent form (ICF), undergoing elective pulmonary resections (lobectomy, segmentectomy, or wedge resection), either through open thoracotomy or through Visually Assisted Thoracotomy surgery (VATS)
- •Patients or legally authorized representatives, who are able to give IC after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period
- •If female of child-bearing potential, patient will present with a negative blood/urine pregnancy test, and will agree to employ adequate birth control measures for the duration of the study
- •Intraoperative-
- •Patients with grade 1 or 2 (Macchiarini scale) air leakage after primary stapling and limited suturing
排除标准
- •Preoperative-
- •Patients who had previous lung surgery (on the same side)
- •Patients with an active, florid infection
- •Patients who have received chemotherapy within the previous 3 weeks.
- •Patients who have received radiation therapy within the previous 4 weeks.
- •Patients with known hypersensitivity to the components of the investigational product and control (human fibrinogen, human thrombin, collagen of any origin, NHS-PEG)
- •Patients undergoing emergency surgery
- •Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period
- •Female patients who are nursing
- •Patients with exposure to another investigational drug or device clinical trial within 30 days prior to enrollment or anticipated in the 30 day study period till the End of study visit.
- •Patient has a clinically significant concurrent medical condition (e.g. concomitant illness, drug/alcohol abuse) that, in the opinion of the investigator, could adversely affect patient's safety and/or compliance with study procedures
- •Patient is a family member or employee of the investigator
- •Intraoperative-
- •Patients with serious complications during surgery, including the need for adhesiolysis, and pneumonectomy.
- •Patients who were treated with any surgical sealant
- •Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
- •Patients with any other intraoperative findings identified by the surgeon that may preclude the conduct of the study procedure
研究组 & 干预措施
Hemopatch
Experimental
Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and either Hemopatch or TachoSil applied.
干预措施: Hemopatch (Device)
TachoSil
Active Comparator
Patients undergo elective pulmonary resection. Following resection, primary stapling and suturing will be done and air leakage will be assessed. If a specific grade-level of air leakage is present, patients will be randomized and either Hemopatch or TachoSil applied.
干预措施: Tachosil (Device)
结局指标
主要结局
Duration of postoperative air leakage
时间窗: Day 1 to Day 30
次要结局
- Incidence of pre-defined postoperative Adverse Events of Special Interest (AESIs)(Day 1 to Day 30)
- Number of additional procedures needed(Day 1 to Day 30)
- Time in surgery (minutes) from incision to closure(Day 1)
- Number of unplanned interventions(Day 1 to Day 30)
- Time to chest tube removal(Day 1 to Day 30)
- Length of stay in hospital (days)(Day 1 to Day 30)
- Number of patches used intra-operatively(Day 1)
- Incidence of patients with prolonged air leakage defined as air leakage > 5 Days(Day 5 to Day 30)
- Incidence of intraoperative treatment failure(Day 1)
研究者
研究点 (14)
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