Overview

This trial is active, not recruiting.

Condition hernia repair with compartment syndrome
Treatments flex hd, strattice
Phase phase 4
Sponsor University of Kentucky
Start date March 2011
End date June 2015
Trial size 45 participants
Trial identifier NCT01597128, 11-0080-P6A

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Mesh Type
flex hd
Flex HD mesh for hernia repair
(Active Comparator)
Use of a second mesh type
strattice
Strattice mash for hernia repair

Primary Outcomes

Measure
Safety
time frame: 12 months

Secondary Outcomes

Measure
Efficacy
time frame: 12 months
Long Term Safety
time frame: up to 3.5 years
Long Term Efficacy
time frame: up to 3.5 years

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

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
Principal investigator John S Roth, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Kentucky.