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Parastomal Reinforcement With Strattice (PriSm)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT00771407
First received: October 10, 2008
Last updated: August 25, 2015
Last verified: August 2015
Results First Received: August 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Condition: Parastomal Hernia
Interventions: Device: Strattice Reconstructive Matrix
Other: Standard ostomy creation

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
7 subjects failed eligibility to continue to protocol-specific surgery after randomization.

Reporting Groups
  Description
Strattice Fascial Inlay Strattice placed as a fascial inlay to support the ostomy site
Standard Ostomy Construction Ostomy created in the standard fashion

Participant Flow:   Overall Study
    Strattice Fascial Inlay   Standard Ostomy Construction
STARTED   60   60 
COMPLETED   40   35 
NOT COMPLETED   20   25 



  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.
The Baseline Analysis population is the 113 subjects in the Intent To Treat population.

Reporting Groups
  Description
Strattice Fascial Inlay Strattice placed as a fascial inlay to support the ostomy site
Standard Ostomy Construction Ostomy created in the standard fashion
Total Total of all reporting groups

Baseline Measures
   Strattice Fascial Inlay   Standard Ostomy Construction   Total 
Overall Participants Analyzed 
[Units: Participants]
 55   58   113 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.25  (13.65)   59.14  (14.36)   59.7  (13.97) 
Gender 
[Units: Participants]
     
Female   25   29   54 
Male   30   29   59 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   5   1   6 
White   48   57   105 
More than one race   0   0   0 
Unknown or Not Reported   2   0   2 
Region of Enrollment 
[Units: Participants]
     
United States   55   58   113 


  Outcome Measures

1.  Primary:   Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.   [ Time Frame: 24 months ]

2.  Secondary:   Stoma Complications   [ Time Frame: 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Stoma Complications   [ Time Frame: more than 1 month postoperatively ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Stoma Quality of Life   [ Time Frame: Serially over 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Chief Medical Officer
Organization: LifeCell Corporation
phone: 908-947-1104
e-mail: mfranz@lifecell.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT00771407     History of Changes
Other Study ID Numbers: LFC2008.01.01
Study First Received: October 10, 2008
Results First Received: August 20, 2013
Last Updated: August 25, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration