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

Air Leak From Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450265
• Other study ID #: BXU513667
• Secondary ID: 2017-003931-12
• Status: Completed
• Phase: N/A
• Start date: June 26, 2018
• Est. completion date: July 9, 2019

Study information

• Verified date: April 2020
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: July 9, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Air Leak From Lung

Intervention

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

Locations

Country	Name	City	State
Italy	Baxter Investigational Site	Catania
Italy	Baxter Investigational Site	Milan
Italy	Baxter Investigational Site	Padova
Italy	Baxter Investigational Site	Pisa
Italy	Baxter Investigational Site	Rome
Italy	Baxter Investigational Site	Rome
Italy	Baxter Investigational Site	Rome
Spain	Baxter Investigational Site	Alzira	Valencia
Spain	Baxter Investigational Site	Madrid
Spain	Baxter Investigational Site	Madrid	Community Of Madrid
Spain	Baxter Investigational Site	Madrid	Community Of Madrid
Spain	Baxter Investigational Site	Madrid	Community Of Madrid
Spain	Baxter Investigational Site	Madrid	Getafe
Spain	Baxter Investigational Site	Seville	Andalucia

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of postoperative air leakage		Day 1 to Day 30
Secondary	Incidence of intraoperative treatment failure		Day 1
Secondary	Incidence of patients with prolonged air leakage defined as air leakage > 5 Days		Day 5 to Day 30
Secondary	Number of additional procedures needed	Type of procedures include chest drainage, re-operation, respiratory assistance, and blood transfusion	Day 1 to Day 30
Secondary	Time to chest tube removal		Day 1 to Day 30
Secondary	Time in surgery (minutes) from incision to closure		Day 1
Secondary	Length of stay in hospital (days)		Day 1 to Day 30
Secondary	Number of unplanned interventions		Day 1 to Day 30
Secondary	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
Secondary	Number of patches used intra-operatively		Day 1