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

Baxter Healthcare Corporation1 site in 1 country279 target enrollmentJune 26, 2018

ConditionsAir Leak From Lung

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Air Leak From Lung
Sponsor: Baxter Healthcare Corporation
Enrollment: 279
Locations: 1
Primary Endpoint: Duration of postoperative air leakage
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 26, 2018

End Date

July 9, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Baxter Healthcare Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Duration of postoperative air leakage

Time Frame: Day 1 to Day 30

Secondary Outcomes

Time to chest tube removal(Day 1 to Day 30)
Number of unplanned interventions(Day 1 to Day 30)
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)
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)