Clinical Trial: Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair

Brief Summary: The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring VHWG Grade 3 midline hernia repair.

Detailed Summary: Approximately 85 subjects, at approximately 12 sites across Europe will be enrolled and treated to study the use of Phasix™ Mesh. All treated subjects will be followed for 2 years post-implantation.
Sponsor: C. R. Bard

Current Primary Outcome: Surgical Site Occurrence [ Time Frame: 3 Months ]

Proportions of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question <Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?> is answered with <yes>


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Surgical Site Occurrence [ Time Frame: 24 Months ]
    Proportions of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question <Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?> is answered with <yes> "
  • Hernia Recurrence [ Time Frame: 24 Months ]
    Proportion of subjects with hernia recurrence. Hernia recurrence rates will be assessed by physical examination (or if standard of care via CT/MRI or ultrasonography) at each study visit through 24 months. A recurrent hernia will be defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure.
  • Surgical Site Infections [ Time Frame: 24 Months ]
    Proportion of subjects with surgical site infections. Infections at the surgical site will be assessed by physical examination at each study visit through 24 months. If an infection is suspected, a routine culture, obtained via each site's standard protocol, should be obtained to determine cell count and type (i.e. yeast, gram positive or gram negative bacteria, or other). If genus and species of the culture are identified as part of the routine practice at the site, that information should be recorded. Classification will follow the CDC guidelines for superficial, deep and organ/space surgical site infections.
  • Change in Pain [ Time Frame: 24 Months ]
    Mean change in self-reported pain measured on a Visual Analog Scale
  • Incidence Device-related Adverse Events [ Time Frame: 24 Months ]
  • Rate of Reoperation due to Index Hernia Repair [ Time Frame: 24 Months ]
    Rate of reoperation due to the index hernia repair
  • Carolinas Comfort Scale [ Time Frame: 24 Months ]
    Change in self-reported quality of life measured by Carolinas Comfort Scale®
  • EuroQol-5D [ Time Frame: 24 Months ]
    Change in self-reported quality of life measured by EuroQol-5D (EQ-5D™)
  • Surgical procedure time as measured from incision to closure [ Time Frame: 1 day ]
    Surgical procedure time as measured from incision to closure (skin to skin)
  • Time Until Return to Work [ Time Frame: 24 Months ]
  • Length of Hospital Stay [ Time Frame: 1 Month ]
    Up to 1 month
  • Cost of Care [ Time Frame: 24 Months ]
    Cost of care measured via treatment costs related to length of stay and surgery site occurrence


Original Secondary Outcome: Same as current

Information By: C. R. Bard

Dates:
Date Received: February 11, 2016
Date Started: February 2016
Date Completion: September 2019
Last Updated: May 16, 2017
Last Verified: May 2017