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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
John Roth, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01597128
First received: May 9, 2012
Last updated: January 26, 2017
Last verified: October 2016
  Purpose
This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.

Condition Intervention
Hernia Repair With Compartment Syndrome
Device: Flex HD
Device: Strattice

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Hernia Recurrence [ Time Frame: 12 months ]
    Recurrence of hernia based on physical exam and /or CT scan.

  • Wound Occurrence [ Time Frame: 12 months ]
    superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.

  • Wound Occurrence: Deep Wound Infection [ Time Frame: 12 Months ]
  • Wound Occurrence: Wound Abscess [ Time Frame: 12 Months ]
  • Wound Occurrence: Wound Seroma [ Time Frame: 12 Months ]
  • Wound Occurrence: Wound Cellulitis [ Time Frame: 12 Months ]
  • Wound Occurrence: Wound Dehiscence [ Time Frame: 12 Months ]
  • Wound Occurrence: Superficial Wound Infection [ Time Frame: 12 months ]
    Superficial wound infection

  • Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation [ Time Frame: 12 months ]
    Change in SF12 Physical Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm, so a 12 month difference of 10 would equal a 1 standard deviation change; An increase is better.

  • Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation [ Time Frame: 12 months ]
    Change in SF12 Mental Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm; An increase is better.


Enrollment: 35
Study Start Date: March 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Flex HD
Mesh Type
Device: Flex HD
Flex HD mesh for hernia repair
Active Comparator: Strattice
Use of a second mesh type
Device: Strattice
Strattice mesh for hernia repair

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597128

Locations
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
John Roth
Investigators
Principal Investigator: John S Roth, M.D. University of Kentucky
  More Information

Additional Information:
Responsible Party: John Roth, PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT01597128     History of Changes
Other Study ID Numbers: 11-0080-P6A
Study First Received: May 9, 2012
Results First Received: June 24, 2016
Last Updated: January 26, 2017

Keywords provided by University of Kentucky:
Hernia
human tissue
mesh

Additional relevant MeSH terms:
Hernia
Compartment Syndromes
Pathological Conditions, Anatomical
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on March 27, 2017