Study to Evaluate Safety & Effectiveness of Vascular Sealant System
To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.
Peripheral Vascular Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Randomized Study to Evaluate Safety & Effectiveness of Vascular Sealant to Control Suture Line Bleeding|
- The primary effectiveness endpoint is sealing success defined as complete anastomotic suture line sealing within 10 minutes following restoration of blood flow without use of an adjunctive hemostatic technique different from the assigned treatment. [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]
- The proportion of immediate sealing successes at treated anastomoses by treatment group, with immediate sealing success defined as a site with no suture line bleeding after blood flow is restored [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]
- The proportion of overall sealing successes (within 10 minutes) at treated anastomoses in each treatment group. [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]
- At each site, time to hemostasis was determined from the time circulation was restored after treatment application until bleeding had stopped (assessed at intervals of 1, 3, 5, 7.5 and 10 minutes). [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]
- Time to wound closure was determined, with wound closure defined as the elapsed time between initial clamp removal at the last anastomotic site until skin closure. [ Time Frame: intra-operative ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2007|
|Study Completion Date:||May 2008|
Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
Active Comparator: GELFOAM/THROMBIN
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.