Hernia Repair With Compartment Syndrome
Conditions
Keywords
Hernia, human tissue, mesh
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.
Interventions
Sponsors
John Roth
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
All subjects were identified in the Minimally Invasive Surgery Clinic at the University of Kentucky Medical Center. Recruitment started in March of 2011 and ended in May of 2014
Participants by arm
| Arm | Count |
|---|---|
| Flex HD Human Acellular Dermal Matrix: Flex HD mesh for hernia repair | 18 |
| Strattice Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair | 17 |
| Total | 35 |
Baseline characteristics
| Characteristic | Flex HD | Strattice | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 10 | 58 years STANDARD_DEVIATION 12 | 58 years STANDARD_DEVIATION 10.8 |
| BMI | 34 kg/m^2 STANDARD_DEVIATION 7 | 34 kg/m^2 STANDARD_DEVIATION 6 | 34 kg/m^2 STANDARD_DEVIATION 6.3 |
| Number of Participants Who Were Employed Prior to the Hernia Repair | 3 participants | 5 participants | 8 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 16 Participants | 34 Participants |
| Region of Enrollment United States | 18 participants | 17 participants | 35 participants |
| Sex: Female, Male Female | 8 Participants | 13 Participants | 21 Participants |
| Sex: Female, Male Male | 10 Participants | 4 Participants | 14 Participants |
| Smoker | 10 participants | 12 participants | 22 participants |
| With Prior Defect | 11 participants | 7 participants | 18 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 18 | 14 / 17 |
| serious Total, serious adverse events | 0 / 18 | 2 / 17 |
Outcome results
Primary
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.
Time frame: 12 months
Population: Patients with 12 month completion of the SF12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flex HD | Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation | 0 Normalized scores | Standard Deviation 12 |
| Strattice | Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation | 6 Normalized scores | Standard Deviation 13 |
Primary
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
Population: Patients with 12 month completion of the SF12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flex HD | Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation | 3 Normalized scores | Standard Deviation 8 |
| Strattice | Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation | 2 Normalized scores | Standard Deviation 8 |
Primary
Hernia Recurrence
Recurrence of hernia based on physical exam and /or CT scan.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flex HD | Hernia Recurrence | 11 percentage of patients |
| Strattice | Hernia Recurrence | 12 percentage of patients |
Primary
Wound Occurrence
superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flex HD | Wound Occurrence | 17 percentage of patients |
| Strattice | Wound Occurrence | 29 percentage of patients |
Primary
Wound Occurrence: Deep Wound Infection
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flex HD | Wound Occurrence: Deep Wound Infection | 0 percentage of patients |
| Strattice | Wound Occurrence: Deep Wound Infection | 6 percentage of patients |
Primary
Wound Occurrence: Superficial Wound Infection
Superficial wound infection
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flex HD | Wound Occurrence: Superficial Wound Infection | 17 percent of patients |
| Strattice | Wound Occurrence: Superficial Wound Infection | 29 percent of patients |
Primary
Wound Occurrence: Wound Abscess
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flex HD | Wound Occurrence: Wound Abscess | 11 percentage of patients |
| Strattice | Wound Occurrence: Wound Abscess | 18 percentage of patients |
Primary
Wound Occurrence: Wound Cellulitis
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flex HD | Wound Occurrence: Wound Cellulitis | 0 percentage of patients |
| Strattice | Wound Occurrence: Wound Cellulitis | 6 percentage of patients |
Primary
Wound Occurrence: Wound Dehiscence
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flex HD | Wound Occurrence: Wound Dehiscence | 11 percentage of patients |
| Strattice | Wound Occurrence: Wound Dehiscence | 0 percentage of patients |
Primary
Wound Occurrence: Wound Seroma
Time frame: 12 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Flex HD | Wound Occurrence: Wound Seroma | 11 percentage of patients |
| Strattice | Wound Occurrence: Wound Seroma | 12 percentage of patients |