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Hernia of Abdominal WallPhase 4NCT01987700

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

A Phase 4 study testing FLEX-HD and Strattice in people with Hernia of Abdominal Wall, run by Musculoskeletal Transplant Foundation at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hernia of Abdominal Wall
What is being tested?
FLEX-HD and Strattice
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesUnited States
Study dates
Jul 2013to 25 Aug 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • < 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
Show all 24Show fewer
  • 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)

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • CentraState Medical Center

    Freehold, New Jersey, 07728

  • Pines Surgical

    Pembroke Pines, Florida, 33028

  • Washington University in St Louis, Barnes Jewish Hospital

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
FLEX-HD, Strattice
Keywords
Abdominal Hernia Repair, Dermal Allograft, Mesh, Component Separation
Medical subject headings
Hernia, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FLEX-HDDevice

    Also called Human Acellular Dermal Matrix (HADM)

  • StratticeDevice

    Also called Porcine Acellular Dermal Matrix (PADM)

Study groups in NCT01987700
Study groupRoleWhat they receive
FLEX-HD (underlay)Active comparatorFLEX-HD human acellular dermal matrix applied using an underlay technique
Receives: Device: FLEX-HD
FLEX-HD (overlay)Active comparatorFLEX-HD human acellular dermal matrix applied using an overlay technique
Receives: Device: FLEX-HD
Strattice (underlay)Active comparatorStrattice porcine acellular dermal matrix applied using an underlay technique
Receives: Device: Strattice
Strattice (overlay)Active comparatorStrattice porcine acellular dermal matrix applied using an overlay technique
Receives: Device: Strattice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 months

Secondary outcomes (2)

  1. 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.

    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.

    Measured: 12 months

  2. 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.

    Measured: 3 months, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2013 (estimated)
  2. Study startJul 2013
  3. Primary completion30 Jun 2018
  4. Study completion25 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01987700
Sponsor's protocol ID
MTF 01-13
Status last verified
Sep 2015
First submitted
13 Nov 2013
Last updated
19 Sep 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FLEX-HD and Strattice in people with Hernia of Abdominal Wall, run by Musculoskeletal Transplant Foundation at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01987700.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2018.

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