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)
|ClinicalTrials.gov Identifier: NCT01597128|
Recruitment Status : Completed
First Posted : May 11, 2012
Results First Posted : March 16, 2017
Last Update Posted : March 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hernia Repair With Compartment Syndrome||Device: Flex HD Device: Strattice||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Start Date :||March 2011|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Active Comparator: Flex HD
Device: Flex HD
Flex HD mesh for hernia repair
Active Comparator: Strattice
Use of a second mesh type
Strattice mesh for hernia repair
- Hernia Recurrence [ Time Frame: 12 months ]Recurrence of hernia based on physical exam and /or CT scan.
- Wound Occurrence [ Time Frame: 12 months ]superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.
- 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 [ Time Frame: 12 months ]Superficial wound infection
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597128
|United States, Kentucky|
|University of Kentucky Medical Center|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||John S Roth, M.D.||University of Kentucky|