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

Primary Purpose

Hernia of Abdominal Wall

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
FLEX-HD
Strattice
Sponsored by
Musculoskeletal Transplant Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia of Abdominal Wall focused on measuring Abdominal Hernia Repair, Dermal Allograft, Mesh, Component Separation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pines Surgical
  • Washington University in St Louis, Barnes Jewish Hospital
  • CentraState Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

FLEX-HD (underlay)

FLEX-HD (overlay)

Strattice (underlay)

Strattice (overlay)

Arm Description

FLEX-HD human acellular dermal matrix applied using an underlay technique

FLEX-HD human acellular dermal matrix applied using an overlay technique

Strattice porcine acellular dermal matrix applied using an underlay technique

Strattice porcine acellular dermal matrix applied using an overlay technique

Outcomes

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

Full Information

First Posted
November 13, 2013
Last Updated
September 18, 2018
Sponsor
Musculoskeletal Transplant Foundation
Collaborators
Washington University School of Medicine, Pines Surgical, Meridian Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT01987700
Brief Title
Multi-Center Study To Examine The Use Of Flex HD® And Strattice In The Repair Of Large Abdominal Wall Hernias
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
August 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Musculoskeletal Transplant Foundation
Collaborators
Washington University School of Medicine, Pines Surgical, Meridian Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia of Abdominal Wall
Keywords
Abdominal Hernia Repair, Dermal Allograft, Mesh, Component Separation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FLEX-HD (underlay)
Arm Type
Active Comparator
Arm Description
FLEX-HD human acellular dermal matrix applied using an underlay technique
Arm Title
FLEX-HD (overlay)
Arm Type
Active Comparator
Arm Description
FLEX-HD human acellular dermal matrix applied using an overlay technique
Arm Title
Strattice (underlay)
Arm Type
Active Comparator
Arm Description
Strattice porcine acellular dermal matrix applied using an underlay technique
Arm Title
Strattice (overlay)
Arm Type
Active Comparator
Arm Description
Strattice porcine acellular dermal matrix applied using an overlay technique
Intervention Type
Device
Intervention Name(s)
FLEX-HD
Other Intervention Name(s)
Human Acellular Dermal Matrix (HADM)
Intervention Type
Device
Intervention Name(s)
Strattice
Other Intervention Name(s)
Porcine Acellular Dermal Matrix (PADM)
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence of Functional Hernia Recurrence
Description
Subjective comparisons regarding the integrity of repair/eventration/need for reoperation will be based on clinical assessment, photographs, and/ or radiographically. 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. 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.
Time Frame
12 months
Title
Patient Satisfaction
Description
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.
Time Frame
3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant Bochicchio, MD, MPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pines Surgical
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Washington University in St Louis, Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CentraState Medical Center
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States

12. IPD Sharing Statement

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

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