NCT00925444

Staple-line Reinforcement for Prevention of Pulmonary Air Leakage

Medical and Economic Evaluation of FORESEAL Versus the Current Therapeutic Approach (Stapling Alone or Associated With Tissue Sealant) in Terms of Air Leakage Duration After Lung Resection for Cancer.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with tissue sealant or glue in terms of air leakage duration after lung resection for cancer. Hypothesis: to show a significant difference of 1 day in the average duration of air leakage between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).

Detailed description

Air leaks continue to be the most common complication after pulmonary resection even using a stapling device. Double chest tubes after lobectomy is a well established method for drainage of the pleural cavity to allow adequate expansion of the remaining lung. FORESEAL has been developed to reduce air leaks by buttressing the staple line. It is a absorbable vegetal biopolymer in the form of sleeves, CE marked and indicated for prevention of air leakage after pulmonary resection with stapling device. It acts as a suture reinforcement as well as a sealant thanks to its jellification. Sealants are also commonly used in addition to stapling to prevent air leakage. The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with sealants. This is a multi centre, prospective controlled and randomised clinical study.

Conditions

• Lung Neoplasms
• Pulmonary Surgical Procedures
• Surgical Staplers
• Tissue Adhesives
• Chest Tubes

Interventions

Type	Name	Description
DEVICE	FOREseal	a pair of alginate sleeves for linear cutting staplers used in lung surgery
DEVICE	Stapling	Stapling alon or associated with sealants

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-06-22
• Last updated: 2013-09-18

Locations

1 site across 1 country: France