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
• Sponsor: John Roth
• Information provided by (Responsible Party): John Roth, University of Kentucky

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Hernia Repair With Compartment Syndrome	Device: Flex HD; Device: Strattice	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Flex HD; Mesh Type	Device: Flex HD; Flex HD mesh for hernia repair
Active Comparator: Strattice; Use of a second mesh type	Device: Strattice; Strattice mesh for hernia repair

Outcome Measures

Primary Outcome Measures :

1. Hernia Recurrence [ Time Frame: 12 months ]
   Recurrence of hernia based on physical exam and /or CT scan.
2. Wound Occurrence [ Time Frame: 12 months ]
   superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.
3. Wound Occurrence: Deep Wound Infection [ Time Frame: 12 Months ]
4. Wound Occurrence: Wound Abscess [ Time Frame: 12 Months ]
5. Wound Occurrence: Wound Seroma [ Time Frame: 12 Months ]
6. Wound Occurrence: Wound Cellulitis [ Time Frame: 12 Months ]
7. Wound Occurrence: Wound Dehiscence [ Time Frame: 12 Months ]
8. Wound Occurrence: Superficial Wound Infection [ Time Frame: 12 months ]
   Superficial wound infection
9. 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.
10. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Kentucky

University of Kentucky Medical Center

Lexington, Kentucky, United States, 40536

Sponsors and Collaborators

John Roth

Investigators

• Principal Investigator: John S Roth, M.D.; University of Kentucky

More Information

Additional Information:

Musculoskeletal Transplant Foundation 

• Responsible Party: John Roth, PI, University of Kentucky
• ClinicalTrials.gov Identifier: NCT01597128
• Other Study ID Numbers: 11-0080-P6A
• First Posted: May 11, 2012
• Results First Posted: March 16, 2017
• Last Update Posted: March 16, 2017
• Last Verified: October 2016

Keywords provided by John Roth, University of Kentucky:

Hernia; human tissue; mesh

Additional relevant MeSH terms:

Compartment Syndromes; Hernia; Pathological Conditions, Anatomical; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases