Study to Evaluate Safety & Effectiveness of Vascular Sealant System - Full Text View

Sponsor:	Confluent Surgical
Information provided by:	Confluent Surgical
ClinicalTrials.gov Identifier:	NCT00439309

Purpose

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

Condition	Intervention	Phase
Peripheral Vascular Disease	Device: Gelfoam/Thrombin Device: VascuSeal	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Study to Evaluate Safety & Effectiveness of Vascular Sealant to Control Suture Line Bleeding

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease Surgery Vascular Diseases

Drug Information available for: Thrombin alfa

U.S. FDA Resources

Further study details as provided by Confluent Surgical:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	69
Study Start Date:	April 2007
Study Completion Date:	May 2008

Arms	Assigned Interventions
VascuSeal: Experimental 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.	Device: VascuSeal VascuSeal
GELFOAM/THROMBIN: Active Comparator GELFOAM/THROMBIN	Device: Gelfoam/Thrombin Gelfoam/Thrombin

Arms

Assigned Interventions

VascuSeal: Experimental

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.

Device: VascuSeal

VascuSeal

GELFOAM/THROMBIN: Active Comparator

GELFOAM/THROMBIN

Device: Gelfoam/Thrombin

Gelfoam/Thrombin

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject was > 18 years of age. Scheduled for elective vascular surgery that entails placement of a PTFE vascular graft including extra-anatomic, infrainguinal bypass, and primary and secondary arteriovenous access procedures. Subject was willing and able to comply with all aspects of the treatment and evaluation schedule. Informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site

Exclusion Criteria:

Subject had a known local or systemic infection. Subjects with known coagulopathies including hemophilia, factor deficiencies, platelet count < 80,000 u/mL, heparin induced thrombocytopenia or uncorrected INR > 1.5. Subject was participating in a clinical trial that requires treatment with another investigational device or drug. Subject was lactating or pregnant, or does not agree to use contraception for the duration of the study. Subject had a known hypersensitivity to any components of bovine thrombin preparations and/or material of bovine origin. The investigator determined that the subject should not be included in the study for reason(s) not already specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439309

Locations

United States, Massachusetts
Confluent Surgical, Inc.
Waltham, Massachusetts, United States, 02451

Sponsors and Collaborators

Confluent Surgical

Investigators

Study Director:

Vladimir I Scerbin

Confluent Surgical

More Information

No publications provided

Responsible Party:	Confluent Surgical ( Vladimir Scerbin - Sr.Director Clinical Affairs )
Study ID Numbers:	VAS-06-001
Study First Received:	February 21, 2007
Last Updated:	February 1, 2010
ClinicalTrials.gov Identifier:	NCT00439309 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Thrombin
Peripheral Vascular Diseases
Coagulants
Therapeutic Uses
Hematologic Agents

Vascular Diseases
Cardiovascular Diseases
Gelatin Sponge, Absorbable
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on February 08, 2010