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

Phase 3

Completed

• Conditions: Pulmonary Diseases; Intraoperative Complications

• Registration Number: NCT00293514
• Lead Sponsor: Nycomed

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-15
• Study First Submitted QC: 2006-02-15
• Study First Posted: 2006-02-17
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-02
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Nycomed; 🇩🇰 Roskilde, Denmark