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A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01205399
First received: September 17, 2010
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
Results First Received: July 5, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Hernia

  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
From September 2010 through October 2011 a total of 78 subjects were enrolled at 4 study centers in the United States. The fifth site was terminated because subject data could not be source verified.

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
AlloMax Surgical Graft Group The study group included eligible subjects who underwent hernia repair using the AlloMax™ Surgical Graft at least 9 months prior to the start of this study.

Participant Flow:   Overall Study
    AlloMax Surgical Graft Group  
STARTED     78  
COMPLETED     78  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
AlloMax Surgical Graft Group No text entered.

Baseline Measures
    AlloMax Surgical Graft Group  
Number of Participants  
[units: participants]
 		  78  
Age  
[units: years]
Mean ± Standard Deviation 		  56.6  ± 11.07  
Gender  
[units: participants]
 		 
Female     43  
Male     35  
Ethnicity (NIH/OMB)  
[units: participants]
 		 
Hispanic or Latino     3  
Not Hispanic or Latino     75  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 		 
American Indian or Alaska Native     3  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     74  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 		 
United States     78  
Body Mass Index  
[units: kilograms per square meter]
Mean ± Standard Deviation 		  36.7  ± 9.92  



  Outcome Measures
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1.  Primary:   Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft   [ Time Frame: 9 + Months ]
  Show Outcome Measure 1

2.  Secondary:   Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.   [ Time Frame: 9+ Months ]
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3.  Secondary:   Procedural Time for AlloMax Surgical Graft Placement.   [ Time Frame: 0 Days ]
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  Serious Adverse Events
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  Other Adverse Events
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  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 less than or equal to 60 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.


Limitations and Caveats
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
Study was designed to use existing data. Limitations include: limited data generalizability given the retrospective, single arm, observational study design.  


Results Point of Contact:  
Name/Title: Dawn Heimer/Director, Clinical Affairs
Organization: C. R. Bard: Davol, Inc.
phone: 401-825-8681
e-mail: dawn.heimer@crbard.com


No publications provided


Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01205399     History of Changes
Other Study ID Numbers: DVL-HE006
Study First Received: September 17, 2010
Results First Received: July 5, 2012
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board