The Evicel Post-Authorization Surveillance Study

This study has been completed.
Sponsor:
Collaborator:
OMRIX Biopharmaceuticals
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01158261
First received: July 6, 2010
Last updated: July 22, 2015
Last verified: July 2015
Results First Received: July 22, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Peripheral Vascular Disease
Hemorrhage
Intervention: Biological: EVICEL ™ Fibrin Sealant (Human)

  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
The first subject was enrolled 04 June 2010 and the last subject was enrolled 15 April 2014. The last data point collected for the trial was 21 May 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
EVICEL® Fibrin Sealant (Human) All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.

Participant Flow:   Overall Study
    EVICEL® Fibrin Sealant (Human)  
STARTED     300  
COMPLETED     283  
NOT COMPLETED     17  
Lost to Follow-up                 9  
Death                 7  
Withdrawal by Subject                 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
EVICEL® Fibrin Sealant (Human) All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.

Baseline Measures
    EVICEL® Fibrin Sealant (Human)  
Number of Participants  
[units: participants]
  300  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     151  
>=65 years     149  
Age [1]
[units: years]
Median (Full Range)
  64   (19 to 91)  
Gender  
[units: participants]
 
Female     120  
Male     180  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     4  
Native Hawaiian or Other Pacific Islander     2  
Black or African American     105  
White     185  
More than one race     4  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     300  
BMI (grouped)  
[units: participants]
 
Underweight     5  
Normal     84  
Overweight     79  
Obese     108  
Morbidly obese     24  
History of Smoking  
[units: participants]
 
Never smoked     108  
Ex-smoker     136  
Current smoker     56  
[1] The study population has a mean age of 62.2 years (std 13.9). The median is reported in the table below.



  Outcome Measures

1.  Primary:   Specific Safety Parameters   [ Time Frame: Up to 4-weeks post-operatively ]


  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
Limitations of the study include the small number of centers involved and the observational nature of the design.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Director of Clinical Development
Organization: Ethicon, Inc
phone: 908-218-2492
e-mail: jbatill2@its.jnj.com


No publications provided


Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01158261     History of Changes
Other Study ID Numbers: 400-08-004
Study First Received: July 6, 2010
Results First Received: July 22, 2015
Last Updated: July 22, 2015
Health Authority: United States: Institutional Review Board