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

John Roth35 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hernia Repair With Compartment Syndrome

Interventions

Flex HDDEVICE

Flex HD mesh for hernia repair

StratticeDEVICE

Strattice mesh for hernia repair

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kentucky Medical Center

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Hernia Recurrence

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

Time frame: 12 months

Wound Occurrence

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

Time frame: 12 months

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

Superficial wound infection

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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