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
Results First Received: November 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Peripheral Vascular Disease
Interventions: Device: Gelfoam/Thrombin
Device: VascuSeal

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects enrolled between 6APR07 & 20MAY08 at: U. Hospitals of Cleveland; Cleveland Clinic; Medical U. of Ohio Toledo; Boston Medical Center; OHSU; Southern Illinois U.; Washington Hospital Center; Penn State Heart & Vascular Inst., Georgetown U.; Brigham & Women’s; Methodist Hospital; Vascular & Transplant Specialists; St. Vincent’s East

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
N/A

Reporting Groups
  Description
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.
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.

Participant Flow for 2 periods

Period 1:   Treatment
    VascuSeal     GELFOAM/THROMBIN  
STARTED     54     15  
COMPLETED     54     15  
NOT COMPLETED     0     0  

Period 2:   Follow-Up
    VascuSeal     GELFOAM/THROMBIN  
STARTED     54     15  
COMPLETED     51     13  
NOT COMPLETED     3     2  
Death                 1                 0  
Lost to Follow-up                 2                 0  
Withdrawal by Subject                 0                 1  
Late response by subject                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    VascuSeal     GELFOAM/THROMBIN     Total  
Number of Participants  
[units: participants]
  54     15     69  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     30     11     41  
>=65 years     24     4     28  
Age  
[units: years]
Mean ± Standard Deviation
  63.45  ± 11.773     60.91  ± 12.958     62.51  ± 11.904  
Gender  
[units: participants]
     
Female     27     8     35  
Male     27     7     34  
Region of Enrollment  
[units: participants]
     
United States     54     15     69  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sealing Success   [ Time Frame: Within 10 minutes following restoration of blood flow ]

2.  Secondary:   Proportion of Immediate Sealing Success at Treated Anastomoses (Anastomoses Level)   [ Time Frame: 60 seconds post restoration of blood flow ]

3.  Secondary:   Proportion of Overall Sealing Successes at Treated Anastomoses (Anastomoses Level)   [ Time Frame: Within 10 minutes post restoration of blood flow ]

4.  Secondary:   Time to Hemostasis   [ Time Frame: Within 10 minutes post restoration of blood flow ]

5.  Secondary:   Time to Wound Closure   [ Time Frame: From initial clamp removal at the last anastomotic site until skin closure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jen Doyle
Organization: Covidien
phone: 781.839.1770
e-mail: Jennifer.doyle@covidien.com


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