- ICH GCP
- US Clinical Trials Registry
- 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 (Flex HD)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University of Kentucky Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Flex HD
Mesh Type
|
Flex HD mesh for hernia repair
|
ACTIVE_COMPARATOR: Strattice
Use of a second mesh type
|
Strattice mesh for hernia repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hernia Recurrence
Time Frame: 12 months
|
Recurrence of hernia based on physical exam and /or CT scan.
|
12 months
|
Wound Occurrence
Time Frame: 12 months
|
superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.
|
12 months
|
Wound Occurrence: Deep Wound Infection
Time Frame: 12 Months
|
12 Months
|
|
Wound Occurrence: Wound Abscess
Time Frame: 12 Months
|
12 Months
|
|
Wound Occurrence: Wound Seroma
Time Frame: 12 Months
|
12 Months
|
|
Wound Occurrence: Wound Cellulitis
Time Frame: 12 Months
|
12 Months
|
|
Wound Occurrence: Wound Dehiscence
Time Frame: 12 Months
|
12 Months
|
|
Wound Occurrence: Superficial Wound Infection
Time Frame: 12 months
|
Superficial wound infection
|
12 months
|
Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation
Time Frame: 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.
|
12 months
|
Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation
Time Frame: 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.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John S Roth, M.D., University of Kentucky
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-0080-P6A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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