Study to Evaluate Safety & Effectiveness of Vascular Sealant System

Peripheral Vascular Disease Clinical Trial

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

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

• NCT number: NCT00439309
• Study type: Interventional
• Source: Integra LifeSciences Corporation
• Status: Terminated
• Phase: N/A
• Start date: April 2007
• Completion date: May 2008