Clinical Trial: Multi-Center Study To Examine The Use Of Flex HD® And Strattice In The Repair Of Large Abdominal Wall Hernias

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized, Prospective, Double-blind, Multi-Center Study To Examine And Compare The Outcomes Associated With The Use Of Flex HD®, A Human Acellular Dermal Matrix, And Strattice™, A Porci

Brief Summary: The primary objective of this study is to examine and compare the outcomes associated with the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large complicated abdominal wall hernias.

Detailed Summary:

At least 100,000 ventral hernia repairs are performed in the U.S. each year. Recently, biologically-based implants derived from acellular human dermis, porcine small intestinal submucosa, and porcine dermis have been reported in a variety of complex abdominal wall repair procedures. A variety of surgical techniques and implant placement methods have been described, with no one standard technique achieving precedence. Biologic implant reinforcement of a myofascial closure by means of component separation, or at a minimum, where three-layer fascial approximation is not possible, sublay placement (i.e., closure of the posterior rectus sheath under the implant) are described strategies. These techniques allow placement of the implant against an intact fascial layer and may improve implant incorporation into host tissue. However, the current literature shows few, if any, prospective, randomized, head-to-head comparisons of human acellular dermal matrix (HADM) allograft and porcine acellular dermal matrix (PADM) xenograft when used as a reinforcing material in the repair of large abdominal hernias by a component separation technique.

The Musculoskeletal Transplant Foundation (MTF) has manufactured and processed Flex HD Acellular Hydrated Dermis. This acellular dermis is derived from human skin. In complicated ventral hernia repairs, this type of graft tissue is necessary. Flex HD has been shown to reduce operative time, lower operative costs and provides minimal elasticity.

The primary objective of this study is to examine and compare the outcomes associated with the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large complicated abdominal wall hernias.


Sponsor: Musculoskeletal Transplant Foundation

Current Primary Outcome: Incidence of true hernia recurrence (True defect in the mesh/repair in which intra-abdominal contents are protruding through the defect) at or before 1 year [ Time Frame: 12 months ]

Quantitative data collected over a one-year period:

  • Recurrent hernias requiring surgical intervention
  • Evidence of Eventration/Hernia Recurrence (Radiographic)
  • Fluid collection (Seroma, Hematoma)
  • Surgical Site Infections
  • Systemic Infections
  • Enterocutaneous Fistula
  • Dehiscence
  • Mesh Failure requiring partial or total removal


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of Functional Hernia Recurrence [ Time Frame: 12 months ]

    Subjective comparisons regarding the integrity of repair/eventration/need for reoperation will be based on clinical assessment, photographs, and/ or radiographically.

    1. Eventration ("E") shall be recorded by observing both angles of the photographs taken at expiration and will be classified as: 1) E-Mild: less than 3 cm in both planes, 2) E-Moderate: Between 3 and 5 cm in both planes 3) E- Severe: More than 5cm in both planes.
    2. The need for reoperation ("R") shall be recorded as 1) R-1: Reoperation needed, or 2) R-2: No Reoperation needed. The statistical relationship between these parameters and the repair material (HADM or PADM) will be studied by means of a chi square test.
  • Patient Satisfaction [ Time Frame: 3 months, 6 months, 12 months ]
    Patient satisfaction ratings via the SF-36 at baseline and at 3, 6, and 12 months following their surgery. Cumulative changes in patient satisfaction will be calculated individually for each patient, collectively for all subjects receiving HADM and for all subjects receiving PADM and then compared collectively to each other.


Original Secondary Outcome: Same as current

Information By: Musculoskeletal Transplant Foundation

Dates:
Date Received: November 13, 2013
Date Started: July 2013
Date Completion: October 2017
Last Updated: September 21, 2015
Last Verified: September 2015