Clinical trial NCT03450265: Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Air Leak From Lung
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2018-03-01
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* 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

Primary outcomes:
measure: Duration of postoperative air leakage
timeFrame: Day 1 to Day 30
Secondary outcomes:
measure: Incidence of intraoperative treatment failure
timeFrame: Day 1
measure: Incidence of patients with prolonged air leakage defined as air leakage > 5 Days
timeFrame: Day 5 to Day 30
measure: Number of additional procedures needed
timeFrame: Day 1 to Day 30
measure: Time to chest tube removal
timeFrame: Day 1 to Day 30
measure: Time in surgery (minutes) from incision to closure
timeFrame: Day 1
measure: Length of stay in hospital (days)
timeFrame: Day 1 to Day 30
measure: Number of unplanned interventions
timeFrame: Day 1 to Day 30
measure: Incidence of pre-defined postoperative Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 to Day 30
measure: Number of patches used intra-operatively
timeFrame: Day 1
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Baxter Investigational Site
city: Milan
country: Italy
facility: Baxter Investigational Site
city: Padova
country: Italy
facility: Baxter Investigational Site
city: Pisa
country: Italy
facility: Baxter Investigational Site
city: Rome
country: Italy
facility: Baxter Investigational Site
city: Rome
country: Italy
facility: Baxter Investigational Site
city: Rome
country: Italy
facility: Baxter Investigational Site
city: Seville
country: Spain
facility: Baxter Investigational Site
state: Andalucia
city: Madrid
country: Spain
facility: Baxter Investigational Site
state: Community Of Madrid
city: Madrid
country: Spain
facility: Baxter Investigational Site
state: Community Of Madrid
city: Madrid
country: Spain
facility: Baxter Investigational Site
state: Community Of Madrid
city: Madrid
country: Spain
facility: Baxter Investigational Site
state: Getafe
city: Alzira
country: Spain
facility: Baxter Investigational Site
state: Valencia
city: Madrid
country: Spain
facility: Baxter Investigational Site
Study officials:
References: