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OpenTrials
Completed

NCT Number: NCT01597128

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.

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Key information

Conditions

Hernia Repair With Compartment Syndrome Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flex HD

Device

Flex HD mesh for hernia repair

Strattice

Device

Strattice mesh for hernia repair

Primary outcomes

  1. Hernia Recurrence

    Time frame: 12 months

    Recurrence of hernia based on physical exam and /or CT scan.

  2. Wound Occurrence

    Time frame: 12 months

    superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.

  3. Wound Occurrence: Deep Wound Infection

    Time frame: 12 Months

  4. Wound Occurrence: Wound Abscess

    Time frame: 12 Months

  5. Wound Occurrence: Wound Seroma

    Time frame: 12 Months

  6. Wound Occurrence: Wound Cellulitis

    Time frame: 12 Months

  7. Wound Occurrence: Wound Dehiscence

    Time frame: 12 Months

  8. Wound Occurrence: Superficial Wound Infection

    Time frame: 12 months

    Superficial wound infection

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

John Roth

Other

Registry information

Acronym: Flex HD

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 11, 2012
Registry last updated
Mar 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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