Trial record 8 of 281 for:    "abdominal wall defect" OR "Hernia, Abdominal"

Multi-Center Study To Examine The Use Of Flex HD® And Strattice In The Repair Of Large Abdominal Wall Hernias

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Musculoskeletal Transplant Foundation
Sponsor:
Collaborators:
Washington University School of Medicine
Pines Surgical
CentraState Medical Center
Information provided by (Responsible Party):
Musculoskeletal Transplant Foundation
ClinicalTrials.gov Identifier:
NCT01987700
First received: November 13, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted
  Purpose

The primary objective of this study is to examine and compare the outcomes associated with the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large complicated abdominal wall hernias.


Condition Intervention Phase
Abdominal Hernia Repair
Device: FLEX-HD
Device: Strattice
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Double-blind, Multi-Center Study To Examine And Compare The Outcomes Associated With The Use Of Flex HD®, A Human Acellular Dermal Matrix, And Strattice™, A Porcine Acellular Dermal Matrix Allograft, When Used As A Reinforcing Material In The Repair Of Large Abdominal Wall Hernias By A Component Separation Technique

Resource links provided by NLM:


Further study details as provided by Musculoskeletal Transplant Foundation:

Primary Outcome Measures:
  • Incidence of true hernia recurrence (True defect in the mesh/repair in which intra-abdominal contents are protruding through the defect) at or before 1 year [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    Quantitative data collected over a one-year period:

    • Recurrent hernias requiring surgical intervention
    • Evidence of Eventration/Hernia Recurrence (Radiographic)
    • Fluid collection (Seroma, Hematoma)
    • Surgical Site Infections
    • Systemic Infections
    • Enterocutaneous Fistula
    • Dehiscence
    • Mesh Failure requiring partial or total removal


Secondary Outcome Measures:
  • Incidence of Functional Hernia Recurrence [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    Subjective comparisons regarding the integrity of repair/eventration/need for reoperation will be based on clinical assessment, photographs, and/ or radiographically.

    1. Eventration ("E") shall be recorded by observing both angles of the photographs taken at expiration and will be classified as: 1) E-Mild: less than 3 cm in both planes, 2) E-Moderate: Between 3 and 5 cm in both planes 3) E- Severe: More than 5cm in both planes.
    2. The need for reoperation ("R") shall be recorded as 1) R-1: Reoperation needed, or 2) R-2: No Reoperation needed. The statistical relationship between these parameters and the repair material (HADM or PADM) will be studied by means of a chi square test.

  • Patient Satisfaction [ Time Frame: 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
    Patient satisfaction ratings via the SF-36 at baseline and at 3, 6, and 12 months following their surgery. Cumulative changes in patient satisfaction will be calculated individually for each patient, collectively for all subjects receiving HADM and for all subjects receiving PADM and then compared collectively to each other.


Estimated Enrollment: 120
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FLEX-HD (underlay)
FLEX-HD human acellular dermal matrix applied using an underlay technique
Device: FLEX-HD
Other Name: Human Acellular Dermal Matrix (HADM)
Active Comparator: FLEX-HD (overlay)
FLEX-HD human acellular dermal matrix applied using an overlay technique
Device: FLEX-HD
Other Name: Human Acellular Dermal Matrix (HADM)
Active Comparator: Strattice (underlay)
Strattice porcine acellular dermal matrix applied using an underlay technique
Device: Strattice
Other Name: Porcine Acellular Dermal Matrix (PADM)
Active Comparator: Strattice (overlay)
Strattice porcine acellular dermal matrix applied using an overlay technique
Device: Strattice
Other Name: Porcine Acellular Dermal Matrix (PADM)

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. However, the current literature shows few, if any, prospective, randomized, head-to-head comparisons of human acellular dermal matrix (HADM) allograft and porcine acellular dermal matrix (PADM) xenograft when used as a reinforcing material in the repair of large abdominal hernias by a component separation technique.

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 primary objective of this study is to examine and compare the outcomes associated with the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large complicated abdominal wall hernias.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or greater
  • Have a BMI <40
  • Have a hernia of at least 200 cm^2
  • Have no contraindications to test material(s)
  • Have a life expectancy greater than 1 year in the opinion of the Investigator
  • Able to provide informed consent
  • Able and willing to return for scheduled study visits over 1 year post-operatively (following research related surgery)

Exclusion Criteria:

  • < 18 years of age
  • Subject is determined to have an America Society of Anesthesiologists' (ASA) physical class of 4, 5, or 6.
  • Have a BMI > 40
  • Have a hernia < 2002 cm
  • Have abdominal loss of domain such that the operation would be impractical or would adversely affect respiratory or cardiovascular function to an unacceptable degree in the opinion of the Investigator
  • Inability to close the fascia primarily without abdominal wall mobilization or component separation
  • Participation in an investigational drug or device study within the past 6 weeks prior to enrollment into this trial
  • Have active necrotizing fasciitis or any other known active local or systemic infection
  • Have a known collagen metabolism disorder or any medical condition that could interfere with normal tissue healing process as determined by the Investigator
  • Have a known active malignancy present and/or had chemotherapy 12 weeks prior to screening or planned chemotherapy within 12 weeks of enrollment with the exception of BCC or SCC
  • Have known moderate to severe cirrhosis which in the opinion of the Investigator would impact the outcome of this trial
  • Have a life expectancy less than 1 year.
  • Be unable to participate in the informed consent process
  • Be unable or unwilling to return for scheduled study visits over the 1 year post-operative assessment period
  • Subject's ventral hernia is related to an organ transplant surgery
  • Received high dose steroids (≥100mg of prednisone) within the past 6 weeks
  • Tobacco use within the past 6 weeks or positive serum cotinine test at time of admission
  • Uncontrolled diabetes (i.e. known HbA1C value > 7%)
  • History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up
  • Pregnancy and/or breastfeeding
  • Enterocutaneous fistula
  • Undergoing concomitant panniculectomy
  • Ventral hernia repairs involving actively infected mesh removal
  • Inability to obtain primary fascial closure (Intra-operatively)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987700

Locations
United States, Florida
Pines Surgical Recruiting
Pembroke Pines, Florida, United States, 33028
Contact: Maury A Jayson, MD    954-392-7770    mjayson@sfurology.com   
Contact: Alvaro Garcia, MD    954 369-5511    alvarogarciamd@gmail.com   
Principal Investigator: Alvarado Garcia, MD         
United States, Missouri
Washington University in St Louis, Barnes Jewish Hospital Recruiting
St Louis, Missouri, United States, 63110
Contact: Kelly Bochicchio, RN, MS       bochicchiok@wustl.edu   
Contact: Bryan Sato, RN, BSN    314 362-1065    satob@wustl.edu   
Principal Investigator: Grant Bochicchio, MD, MPH         
United States, New Jersey
CentraState Medical Center Recruiting
Freehold, New Jersey, United States, 07728
Contact: Jarrod P Kaufman, MD    732-303-3837    jarrod@asacji.com   
Principal Investigator: Jarrod P Kaufman, MD         
Sponsors and Collaborators
Musculoskeletal Transplant Foundation
Washington University School of Medicine
Pines Surgical
CentraState Medical Center
Investigators
Principal Investigator: Grant Bochicchio, MD, MPH Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Musculoskeletal Transplant Foundation
ClinicalTrials.gov Identifier: NCT01987700     History of Changes
Other Study ID Numbers: MTF 01-13
Study First Received: November 13, 2013
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Musculoskeletal Transplant Foundation:
Abdominal Hernia Repair
Dermal Allograft
Mesh
Component Separation

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014