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

Not Applicable

Completed

Conditions: Hernia Repair With Compartment Syndrome

Interventions: Device: Strattice
Device: Flex HD

Registration Number: NCT01597128

Lead Sponsor: John Roth

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strattice	Strattice	Use of a second mesh type
Flex HD	Flex HD	Mesh Type

Primary Outcome Measures

Name	Time	Method
Hernia Recurrence	12 months	Recurrence of hernia based on physical exam and /or CT scan.
Wound Occurrence	12 months	superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.
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	12 months	Superficial wound infection
Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation	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	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.