Study to Evaluate Safety & Effectiveness of Vascular Sealant System

This study has been terminated.
(Business Decision)
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT00439309
First received: February 21, 2007
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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


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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Sealing Success [ Time Frame: Within 10 minutes following restoration of blood flow ] [ Designated as safety issue: Yes ]
    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. The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.


Secondary Outcome Measures:
  • Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level) [ Time Frame: 60 seconds post restoration of blood flow ] [ Designated as safety issue: Yes ]
    A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow

  • Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level) [ Time Frame: Within 10 minutes post restoration of blood flow ] [ Designated as safety issue: Yes ]
    A site with no suture line bleeding after blood flow is restored and monitored for a minimum period of 60 seconds to confirm cessation of blood flow.

  • Time to Hemostasis [ Time Frame: Within 10 minutes post restoration of blood flow ] [ Designated as safety issue: Yes ]
    Time to hemostasis determined from time circulation restored after treatment application until bleeding stopped (assessed at intervals of immediate, 1, 3, 5, 7.5 and 10 min). For subject with two sites, time to hemostasis of both sites used for analysis. Subjects for whom bleeding had not stopped within 10 min considered censored observations.

  • Time to Wound Closure [ Time Frame: From initial clamp removal at the last anastomotic site until skin closure ] [ Designated as safety issue: Yes ]
    Time to wound closure was defined as the elapsed time between initial clamp removal at the last anastomotic site until skin closure. This endpoint was analyzed using the log-rank test to compare the two treatment groups. The Kaplan-Meier method was used to obtain estimated median times to wound closure and the corresponding 95% confidence intervals for each treatment group.


Enrollment: 69
Study Start Date: April 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VascuSeal
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
Other Name: Vascular Sealant System
Active Comparator: GELFOAM/THROMBIN
GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
Device: Gelfoam/Thrombin
Gelfoam/Thrombin
Other Name: absorbable gelatin compressed sponge

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Integra LifeSciences Corporation
Investigators
Study Director: Vladimir I Scerbin Confluent Surgical
  More Information

No publications provided

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT00439309     History of Changes
Other Study ID Numbers: VAS-06-001
Study First Received: February 21, 2007
Results First Received: November 7, 2013
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Gelatin Sponge, Absorbable
Thrombin
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014