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 examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.
Hernia Repair With Compartment Syndrome
Device: Flex HD
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]• Safety is estimated as the proportion of subjects who experience serious adverse events (SAEs) during the follow-up period of 12 months. Attempts will be made to determine if SAEs are related to the surgical procedure or are attributable to the mesh material.
- Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]Proportion of subjects experiencing a) clinical hernia repair failure (either laxity/bulging or hernia recurrence) or b) surgical site complication that requires intervention, or c) seroma.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Flex HD
Device: Flex HD
Flex HD mesh for hernia repair
Active Comparator: Strattice
Use of a second mesh type
Strattice mash for hernia repair
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597128
|United States, Kentucky|
|University of Kentucky Medical Center||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Contact: Mandie Zachem, BSN 859-323-6346 ext 246 firstname.lastname@example.org|
|Principal Investigator: John S Roth, MD|
|Principal Investigator:||John S Roth, M.D.||University of Kentucky|