NCT00439309

Study to Evaluate Safety & Effectiveness of Vascular Sealant System

Randomized Study to Evaluate Safety & Effectiveness of Vascular Sealant to Control Suture Line Bleeding

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.

Detailed description

Vascular surgery encompasses a wide range of surgical procedures. In these procedures reduction of blood loss and creation of suture line is of utmost importance to the surgeon. Bleeding at the suture line may require transfusion, as well as prolonged operative and anesthesia time. Suture hole bleeding is common following using synthetic and biological grafts for vascular repair. Several topical hemostatic ans sealing agents have been developed to control suture line bleeding. This new vascular sealant possess high bonding properties, minimal tissue reaction, is biodegradable and absorbed by the body quickly. The primary focus of this study is to compare the safety and effectiveness of the vascular sealant with standard of care methods used today, specifically gelfoam/thrombin and sponge like material.

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Gelfoam/Thrombin	Gelfoam/Thrombin
DEVICE	VascuSeal	VascuSeal

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-02-23
• Last updated: 2017-09-07
• Results posted: 2014-04-01

Locations

1 site across 1 country: United States