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

NCT03450265 | Completed DMC

• 2 other identifiers: BXU5136672017-003931-12
• Study Type: interventional
• Target: 279
• Locations: 2 countries
• Sites: 14

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.

Conditions

Air Leak From Lung

Outcome Measures

Primary Outcomes (1)

• Duration of postoperative air leakage

  Day 1 to Day 30

Secondary Outcomes (9)

• 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

  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

Study Arms (2)

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.

Device: Hemopatch

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.

Device: Tachosil

Interventions

Hemopatch DEVICE

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.

Hemopatch

Tachosil DEVICE

Applied according to the current instruction for use (IFU).

TachoSil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (14)

Baxter Investigational Site

Catania, 95123, Italy

Location

Baxter Investigational Site

Milan, 20141, Italy

Location

Baxter Investigational Site

Padua, 35128, Italy

Location

Baxter Investigational Site

Pisa, 56124, Italy

Location

Baxter Investigational Site

Rome, 144, Italy

Location

Baxter Investigational Site

Rome, 151, Italy

Location

Baxter Investigational Site

Rome, 168, Italy

Location

Baxter Investigational Site

Seville, Andalusia, 41009, Spain

Location

Baxter Investigational Site

Madrid, Getafe, 28905, Spain

Location

Baxter Investigational Site

Madrid, Madrid, 28006, Spain

Location

Baxter Investigational Site

Madrid, Madrid, 28040, Spain

Location

Baxter Investigational Site

Madrid, Madrid, 28933, Spain

Location

Baxter Investigational Site

Alzira, Valencia, 46600, Spain

Location

Baxter Investigational Site

Madrid, 28046, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 1, 2018
• Study Start: June 26, 2018
• Primary Completion: July 9, 2019
• Study Completion: July 9, 2019
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

IT (7); ES (7)