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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 is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
Anna Rockich, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01597128
First received: May 9, 2012
Last updated: July 10, 2013
Last verified: July 2013

May 9, 2012
July 10, 2013
March 2011
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01597128 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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
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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hernia Repair With Compartment Syndrome
  • Device: Flex HD
    Flex HD mesh for hernia repair
  • Device: Strattice
    Strattice mash for hernia repair
  • Active Comparator: Flex HD
    Mesh Type
    Intervention: Device: Flex HD
  • Active Comparator: Strattice
    Use of a second mesh type
    Intervention: Device: Strattice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
March 2015
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:• Have given written Informed Consent

  • Be 18-85 years of age (inclusive)
  • Patient has a ventral or incisional hernia with at least one of the following characteristics

    • Hernia is at least 6cm in transverse dimension
    • History of 2 or more prior ventral or incisional hernia repairs
    • Active or prior infection of the abdominal wall
    • Enterocutaneous fistula to the anterior abdominal wall
    • Mesh requiring mesh removal which would result in a hernia at least 6cm in transverse dimension
  • Patients is scheduled to undergo component separation hernia repair
  • Have an ASA Score of 3 or less
  • Have a BMI between 20 and 55
  • Be a candidate for primary approximation of skin and wound following hernia repair
  • Have a life expectancy of at least 2 years

Exclusion Criteria:

  • Have loss of abdominal domain such that the operation would be impractical or would adversely effect respiratory or cardiovascular function to an unacceptable degree
  • Be a candidate for emergency surgery that would make giving valid Informed Consent impractical
  • Be currently taking part in another clinical study that conflicts with the current study
  • Have active generalized peritonitis or intraperitoneal sepsis
  • Have active necrotizing fasciitis
  • Have active abdominal compartment syndrome
  • Have active untreated metabolic or systemic illness
  • Have known active malignancy present
  • Be unable to give valid informed consent or comply with required follow-up schedule
  • Suffer from mental capacity sufficiently severe to make informed consent unobtainable
Both
18 Years to 85 Years
No
United States
 
NCT01597128
11-0080-P6A
Yes
Anna Rockich, University of Kentucky
University of Kentucky
Not Provided
Principal Investigator: John S Roth, M.D. University of Kentucky
University of Kentucky
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP