Text Size

Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix (RESULTS)

This study has been completed.
Sponsor:
Information provided by:
Synovis Surgical Innovations
ClinicalTrials.gov Identifier:
NCT00566943
First received: November 29, 2007
Last updated: May 23, 2012
Last verified: July 2011
History of Changes
Results First Received: December 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Obesity
Interventions: Device: PSD Veritas Collagen Matrix
Procedure: Roux-en-Y gastric by-pass surgery with no buttress

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at one surgical site in the US from approximately March 2006 through May 2008. One hundred one subjects were entered into the study.

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 their Body Mass Index was less than or equal to 35 or greater than or equal to 65. Subjects could not have a life expectancy of less than 12 months nor a known sensitivity to bovine material.

Reporting Groups
  Description
Control control arm where no buttress is used on stomach or GJ anastomosis staple lines.
PSD Veritas PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.

Participant Flow:   Overall Study
    Control     PSD Veritas  
STARTED     52     49  
COMPLETED     52     49  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Control control arm where no buttress is used on stomach or GJ anastomosis staple lines.
PSD Veritas PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
Total Total of all reporting groups

Baseline Measures
    Control     PSD Veritas     Total  
Number of Participants  
[units: participants]
 		  52     49     101  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     52     49     101  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  42.93  ± 9.18     46.61  ± 10.2     45.3  ± 9.69  
Gender  
[units: participants]
 		     
Female     47     40     87  
Male     5     9     14  
Region of Enrollment  
[units: participants]
 		     
United States     52     49     101  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.   [ Time Frame: Discharge/ 30 days Linear Discharge/30/90 days Circular ]
  Show Outcome Measure 1

2.  Primary:   Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group.   [ Time Frame: Discharge/30 Linear Discharge/30/90 days Circular ]
  Show Outcome Measure 2

3.  Secondary:   Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group   [ Time Frame: Discharge and 30 days ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas.   [ Time Frame: Discharge, 30 and 90 days ]
  Show Outcome Measure 4


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Show More Information