Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia Repair With Compartment Syndrome
Keywords: Hernia
human tissue
mesh
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.

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 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

Primary outcomes:
measure: Hernia Recurrence
timeFrame: 12 months
measure: Wound Occurrence
timeFrame: 12 months
measure: Wound Occurrence: Deep Wound Infection
timeFrame: 12 Months
measure: Wound Occurrence: Wound Abscess
timeFrame: 12 Months
measure: Wound Occurrence: Wound Seroma
timeFrame: 12 Months
measure: Wound Occurrence: Wound Cellulitis
timeFrame: 12 Months
measure: Wound Occurrence: Wound Dehiscence
timeFrame: 12 Months
measure: Wound Occurrence: Superficial Wound Infection
timeFrame: 12 months
measure: Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation
timeFrame: 12 months
measure: Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: John S Roth, M.D.
role: PRINCIPAL_INVESTIGATOR
References: