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

Detailed Description
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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.

Official Title
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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

Conditions
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Hernia Repair With Compartment Syndrome

Intervention / Treatment
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* Device: Flex HD
* Device: Strattice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flex HD<br>Mesh Type | Device: Flex HD<br>* Flex HD mesh for hernia repair<br>|
| Active Comparator: Strattice<br>Use of a second mesh type | Device: Strattice<br>* Strattice mesh for hernia repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia Recurrence | Recurrence of hernia based on physical exam and /or CT scan. | 12 months | 
| Wound Occurrence | superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence. | 12 months | 
| Wound Occurrence: Deep Wound Infection |  | 12 Months | 
| Wound Occurrence: Wound Abscess |  | 12 Months | 
| Wound Occurrence: Wound Seroma |  | 12 Months | 
| Wound Occurrence: Wound Cellulitis |  | 12 Months | 
| Wound Occurrence: Wound Dehiscence |  | 12 Months | 
| Wound Occurrence: Superficial Wound Infection | Superficial wound infection | 12 months | 
| Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation | 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. | 12 months | 
| Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hernia, human tissue, mesh