Clinical Trial: TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open, Randomised, Prospective, Multi-centre, Parallel-group Trial of TachoSil Versus Standard Surgical Treatment in Patients Undergoing Pulmonary Lobectomy for Lung Malignancy and Requiring Treatme
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 Summary:
Sponsor: Nycomed
Current Primary Outcome: 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)
Original Primary Outcome:
- Duration of post-operative air leakage:
- Assessment at the evening of the day of operation (Day 0) and then subsequently twice daily (at morning and evening shifts).
Current Secondary Outcome: Reduction of intra-operative air leakage intensity after first application of trial treatment
Original Secondary Outcome: Reduction of intra-operative air leakage intensity after first application of trial treatment.
Information By: Nycomed
Dates:
Date Received: February 15, 2006
Date Started: February 2006
Date Completion:
Last Updated: May 4, 2012
Last Verified: February 2008
