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Feasibility Study of The Use of FLEX HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrix in The Closure of Abdominal Wall Defects With Component Separation in Clean or Contaminated Cases (Flex HD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Roth, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01597128
First received: May 9, 2012
Last updated: January 26, 2017
Last verified: October 2016
Results First Received: June 24, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Hernia Repair With Compartment Syndrome
Interventions: Device: Flex HD
Device: Strattice

  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
All subjects were identified in the Minimally Invasive Surgery Clinic at the University of Kentucky Medical Center. Recruitment started in March of 2011 and ended in May of 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
Flex HD Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
Strattice Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair

Participant Flow:   Overall Study
    Flex HD   Strattice
STARTED   18   17 
COMPLETED   18   17 
NOT COMPLETED   0   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.
No text entered.

Reporting Groups
  Description
Flex HD Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
Strattice Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
Total Total of all reporting groups

Baseline Measures
   Flex HD   Strattice   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   17   35 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (10)   58  (12)   58  (10.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  44.4%      13  76.5%      21  60.0% 
Male      10  55.6%      4  23.5%      14  40.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      18 100.0%      16  94.1%      34  97.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   5.9%      1   2.9% 
Region of Enrollment 
[Units: Participants]
     
United States   18   17   35 
Smoker 
[Units: Participants]
 10   12   22 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 34  (7)   34  (6)   34  (6.3) 
With Prior Defect 
[Units: Participants]
 11   7   18 
Number of Participants Who Were Employed Prior to the Hernia Repair 
[Units: Participants]
 3   5   8 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hernia Recurrence   [ Time Frame: 12 months ]

2.  Primary:   Wound Occurrence   [ Time Frame: 12 months ]

3.  Primary:   Wound Occurrence: Deep Wound Infection   [ Time Frame: 12 Months ]

4.  Primary:   Wound Occurrence: Wound Abscess   [ Time Frame: 12 Months ]

5.  Primary:   Wound Occurrence: Wound Seroma   [ Time Frame: 12 Months ]

6.  Primary:   Wound Occurrence: Wound Cellulitis   [ Time Frame: 12 Months ]

7.  Primary:   Wound Occurrence: Wound Dehiscence   [ Time Frame: 12 Months ]

8.  Primary:   Wound Occurrence: Superficial Wound Infection   [ Time Frame: 12 months ]

9.  Primary:   Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation   [ Time Frame: 12 months ]

10.  Primary:   Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation   [ Time Frame: 12 months ]


  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
This is a Prospective Quasi-experimental study. Patients were randomized in the traditional sense.


  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: J. Scott Roth, M.D.
Organization: University of Kentucky Medical Center
phone: 859-323-6346 ext 246
e-mail: arockich@uky.edu



Responsible Party: John Roth, University of Kentucky
ClinicalTrials.gov Identifier: NCT01597128     History of Changes
Other Study ID Numbers: 11-0080-P6A
Study First Received: May 9, 2012
Results First Received: June 24, 2016
Last Updated: January 26, 2017