Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery

This study has been completed.
Sponsor:
Information provided by:
Synovis Surgical Innovations
ClinicalTrials.gov Identifier:
NCT00559013
First received: November 14, 2007
Last updated: May 23, 2012
Last verified: July 2011
Results First Received: December 15, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Colorectal Cancer
Intervention: Device: Staple line reinforcement

  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
38 subjects were recruited from two principal investigators and their respective surgical hospitals in the US from approximately February 2007 through October 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were excluded from the study if the met any of the exclusion criteria including having a a body mass index greater than 35, a history of Chron's Disease, or stage IV cancer. There was no washout, run-in or transition period to this study.

Reporting Groups
  Description
PSD Veritas Collagen Matrix Reinforcement Arm Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.

Participant Flow:   Overall Study
    PSD Veritas Collagen Matrix Reinforcement Arm  
STARTED     38  
COMPLETED     38  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
PSD Veritas Collagen Matrix Reinforcement Arm Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.

Baseline Measures
    PSD Veritas Collagen Matrix Reinforcement Arm  
Number of Participants  
[units: participants]
  38  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     27  
>=65 years     11  
Age  
[units: years]
Mean ± Standard Deviation
  57.26  ± 11.44  
Gender  
[units: participants]
 
Female     18  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     38  



  Outcome Measures

1.  Primary:   Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.   [ Time Frame: Discharge and 1 Month post surgery ]


  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
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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 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: Lesa Hobright-Turner, Director of Clinical Affairs
Organization: Synovis
phone: 651-796-7506
e-mail: lesa.hobrightturner@synovissurgical.com


No publications provided


Responsible Party: Lesa Hobright-Turner, Director of Clinical Affairs, Synovis Surgical Innovations
ClinicalTrials.gov Identifier: NCT00559013     History of Changes
Other Study ID Numbers: CP1011, Rev C
Study First Received: November 14, 2007
Results First Received: December 15, 2009
Last Updated: May 23, 2012
Health Authority: United States: Institutional Review Board