Hernia Repair With Compartment Syndrome Clinical Trial
Official title:
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
This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.
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.
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 Musculoskeletal Transplant Foundation (MTF) is a non-profit service organization
dedicated to providing quality allograft tissue through a commitment to excellence in
education, research, recovery and care for recipients, donors and their families. MTF is a
national consortium comprised of academic medical institutions, organ procurement
organizations and tissue recovery organizations. From their inception, they have been both
donor-focused and surgeon-driven. Since their inception in 1987, MTF has recovered more than
60,000 donors and distributed more than 3 million grafts for transplantation.
The Foundation was established by surgeons and teaching institutions to meet the need for a
high quality and consistent allograft supply.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment