TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)

Nycomed

Overview

The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Pulmonary Diseases Intraoperative Complications

Interventions

Fibrinogen (human) + thrombin (human) (TachoSil)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with a diagnosis of lung malignancy with or without metastases may be included in the trial if the entry criteria apply.

Locations (1)

Nycomed

Roskilde, Denmark

Outcomes

Primary Outcomes

Duration of post-operative air leakage: assessment on the evening of the day of operation (Day 0) and then subsequently twice daily (on morning and evening shifts)

Secondary Outcomes

Reduction of intra-operative air leakage intensity after first application of trial treatment

Data from ClinicalTrials.gov

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