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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-26

Study Completion Date

2019-07-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Air Leak From Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Hemopatch

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Tachosil

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Tachosil

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No