Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection

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

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.

Study Overview

• Status: Completed
• Conditions: Air Leak From Lung
• Intervention / Treatment: Device: Hemopatch; Device: Tachosil

• Study Type: Interventional
• Enrollment (Actual): 279
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95123
    • Baxter Investigational Site
  • Milan, Italy, 20141
    • Baxter Investigational Site
  • Padova, Italy, 35128
    • Baxter Investigational Site
  • Pisa, Italy, 56124
    • Baxter Investigational Site
  • Rome, Italy, 144
    • Baxter Investigational Site
  • Rome, Italy, 151
    • Baxter Investigational Site
  • Rome, Italy, 168
    • Baxter Investigational Site
• Spain
  • Madrid, Spain, 28046
    • Baxter Investigational Site
  • Andalucia
    • Seville, Andalucia, Spain, 41009
      • Baxter Investigational Site
  • Community Of Madrid
    • Madrid, Community Of Madrid, Spain, 28006
      • Baxter Investigational Site
    • Madrid, Community Of Madrid, Spain, 28040
      • Baxter Investigational Site
    • Madrid, Community Of Madrid, Spain, 28933
      • Baxter Investigational Site
  • Getafe
    • Madrid, Getafe, Spain, 28905
      • Baxter Investigational Site
  • Valencia
    • Alzira, Valencia, Spain, 46600
      • Baxter Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemopatch; 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.	Device: Hemopatch; Applied according to the current instruction for use (IFU). According to the IFU, a maximum of 7 Hemopatch 45 x 90 mm patches can be used in adults.
Active Comparator: TachoSil; 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.	Device: Tachosil; Applied according to the current instruction for use (IFU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of postoperative air leakage	Day 1 to Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative treatment failure		Day 1
Incidence of patients with prolonged air leakage defined as air leakage > 5 Days		Day 5 to Day 30
Number of additional procedures needed	Type of procedures include chest drainage, re-operation, respiratory assistance, and blood transfusion	Day 1 to Day 30
Time to chest tube removal		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 unplanned interventions		Day 1 to Day 30
Incidence of pre-defined postoperative Adverse Events of Special Interest (AESIs)	Pre-defined AEs include Pneumothorax, Bronchopleural fistula, Emphysema (subcutaneous and mediastinal), Pleural effusions, Postoperative respiratory failure, Empyema, Allergic reactions in reasonable temporal relationship with the product application	Day 1 to Day 30
Number of patches used intra-operatively		Day 1

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2018
• Primary Completion (Actual): July 9, 2019
• Study Completion (Actual): July 9, 2019

Study Registration Dates

• First Submitted: February 13, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BXU513667; 2017-003931-12 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No