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Ventral Incisional HerniaNCT03034213

Gentrix™ Versus Biological or Prosthetic Mesh

A study testing Gentrix™ Surgical Matrix (Treatment) in people with Ventral Incisional Hernia, run by University of South Florida at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The hypothesis for this study is complex incisional hernia repair using the separation of components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will lead to fewer incisional hernia recurrences and fewer wound complications compared to the same incisional hernia repair techniques… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventral Incisional Hernia
What is being tested?
Gentrix™ Surgical Matrix (Treatment)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesUnited States
Study dates
6 Oct 2017to 16 Jun 2021
Phase
Interventional
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

  • Male and female patients ≥ 18 years old.
  • American Society of Anesthesiologists (ASA) physical status classification of I, II, III or IV.
  • Able to provide informed consent in English or Spanish.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Body Mass Index (BMI) =< 45.
  • Incisional hernia from a midline incision ≥ 4 cm in greatest diameter, or any recurrent incisional hernia.

Who cannot join

  • Any other type of ventral hernia, such as umbilical, epigastric or Spigelian hernia.
  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
  • Allergy or hypersensitivity to materials in porcine-based study products, biological or prosthetic meshes, or personal preference.
  • Contraindications to general anesthesia.
  • Patient undergoing any emergency surgery prior to treatment.
  • Severe comorbid conditions likely to limit survival to less than 3 years in the opinion of the Investigator.
Show all 20Show fewer
  • 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 with abdominal wall mobilization or component separation; confirmed intra-operatively.
  • History of malignancy within the past 5 years except for non-melanoma skin cancer.
  • Known active malignancy present and/or had chemotherapy 12 weeks prior to screening or planned chemotherapy within 12 weeks of treatment with exception of basal cell carcinoma, squamous cell carcinoma, or prostate cancer in situ.
  • Cirrhosis with or without ascites.
  • Received high dose steroids (>/=100mg of prednisone) within the past 6 weeks of screening.
  • Uncontrolled diabetes (i.e. known HbA1C value > 7% within the prior 6 weeks of the Screening Visit).
  • 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.
  • Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.
  • Suspected presence of enterocutaneous fistula.
  • Planned use of external VAC dressing intra-operatively.
  • Suspected bowel obstruction (partial or intermittent), strangulation, peritonitis, or perforation.
  • Active necrotizing fasciitis or any other known active local or systemic infection.
  • Subject report of participation in an investigational drug or device study that would impact the safety or scientific integrity of this study (in the opinion of the Investigator and with the approval of the Sponsor) within the past 6 weeks prior to treatment in this trial.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Tampa General Hospital

    Tampa, Florida, 33606

  • University of South Florida - South Tampa Campus

    Tampa, Florida, 33606

  • University of South Florida Morsani Center for Advanced Health Care

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Randomized, Controlled Trial Comparing Separation of Components Repair With Retrorectus Gentrix™ Surgical Matrix Versus Biological or Prosthetic Mesh for Open Ventral Hernia Repair

The hypothesis for this study is complex incisional hernia repair using the separation of components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will lead to fewer incisional hernia recurrences and fewer wound complications compared to the same incisional hernia repair techniques reinforced with other prosthetic or biologically-derived mesh.

Read the detailed description

Biological and prosthetic mesh products are extensively used in hernia repairs. However, they also have their limitations. Potential complications associated with prosthetic mesh for hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. Potential complications associated with biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent herniation. This study is a two-arm, randomized, controlled trial comparing separation of components repair with retrorectus Gentrix™ Surgical Matrix versus biological or prosthetic mesh for open ventral hernia repair.

Being tested
Gentrix™ Surgical Matrix (Treatment), Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)
Keywords
mesh

What participants receive

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

  • Gentrix™ Surgical Matrix (Treatment)Device

    Gentrix™ Surgical Matrix will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.

  • Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)Device

    A biological or prosthetic mesh (Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend) will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.

Study groups in NCT03034213
Study groupRoleWhat they receive
TreatmentActive comparatorGentrix(TM) Surgical Matrix
Receives: Device: Gentrix™ Surgical Matrix (Treatment)
ControlActive comparatorStandard of care mesh
Receives: Device: Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)

What is being measured

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

  1. Incidence of incisional hernia recurrence

    Measured: 2 years from study incisional hernia repair

Secondary outcomes (11)

  1. Time to incisional hernia recurrence

    Measured: 2 years from study incisional hernia repair

  2. Incidence of wound complications

    Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation

    Measured: 90 days from study incisional hernia repair

  3. Incidence of enterocutaneous fistula formation

    Measured: 2 years from study incisional hernia repair

  4. Mean Carolinas Comfort Scale score

    Patient-centered outcome

    Measured: 2 years from study incisional hernia repair

  5. Mean Visual Analog Scale score

    Patient-centered outcome

    Measured: 2 years from study incisional hernia repair

  6. Mean mesh deployment time

    Defined as the time mesh preparation starts to time mesh placement ends

    Measured: duration of surgery (incisional hernia repair)

  7. Mean procedure time

    Defined as time of incision to time of closure

    Measured: duration of surgery (incisional hernia repair)

  8. Mean total cost of hospitalization for primary admission

    Defined as from surgery to hospital discharge

    Measured: duration of hospitalization for incisional hernia repair

  9. Mean total cost of surgery for primary admission

    Defined as from preoperative preparation to anesthesia discharge

    Measured: duration of surgery (incisional hernia repair)

  10. Mean total cost of narcotic usage for primary admission

    Defined as narcotic use from surgery to hospital discharge

    Measured: duration of hospitalization for incisional hernia repair

  11. Mean total cost of readmissions

    Defined as any hospital readmissions related to ventral hernia complications or recurrence

    Measured: 2 years from study incisional hernia repair

Timeline

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

  1. First posted27 Jan 2017 (estimated)
  2. Study start6 Oct 2017
  3. Primary completion16 Jun 2021
  4. Study completion16 Jun 2021

Why it stopped: Cease of Funding

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03034213
Sponsor's protocol ID
CA2017-002
Status last verified
Sep 2021
First submitted
25 Jan 2017
Last updated
29 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • FitzGerald JF, Kumar AS. Biologic versus Synthetic Mesh Reinforcement: What are the Pros and Cons? Clin Colon Rectal Surg. 2014 Dec;27(4):140-8. doi: 10.1055/s-0034-1394155.

    PubMed 26106284

  • Zhou XH, Melfi CA, Hui SL. Methods for comparison of cost data. Ann Intern Med. 1997 Oct 15;127(8 Pt 2):752-6. doi: 10.7326/0003-4819-127-8_part_2-199710151-00063.

    PubMed 9382393

  • Holihan JL, Alawadi Z, Martindale RG, Roth JS, Wray CJ, Ko TC, Kao LS, Liang MK. Adverse Events after Ventral Hernia Repair: The Vicious Cycle of Complications. J Am Coll Surg. 2015 Aug;221(2):478-85. doi: 10.1016/j.jamcollsurg.2015.04.026. Epub 2015 May 9.

    PubMed 26206646

  • Fekkes JF, Velanovich V. Amelioration of the effects of obesity on short-term postoperative complications of laparoscopic and open ventral hernia repair. Surg Laparosc Endosc Percutan Tech. 2015 Apr;25(2):151-7. doi: 10.1097/SLE.0000000000000100.

    PubMed 25222715

  • Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.

    PubMed 21904861

  • Fischer JP, Wink JD, Tuggle CT, Nelson JA, Kovach SJ. Wound risk assessment in ventral hernia repair: generation and internal validation of a risk stratification system using the ACS-NSQIP. Hernia. 2015 Feb;19(1):103-11. doi: 10.1007/s10029-014-1318-5. Epub 2014 Dec 4.

    PubMed 25472771

  • Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1.

    PubMed 18387468

  • Nielsen K, Poelman MM, den Bakker FM, van der Ploeg T, Bonjer HJ, Schreurs WH. Comparison of the Dutch and English versions of the Carolinas Comfort Scale: a specific quality-of-life questionnaire for abdominal hernia repairs with mesh. Hernia. 2014 Aug;18(4):459-64. doi: 10.1007/s10029-013-1173-9. Epub 2013 Oct 29.

    PubMed 24166693

Questions about this trial

What is this clinical trial studying?

A study testing Gentrix™ Surgical Matrix (Treatment) in people with Ventral Incisional Hernia, run by University of South Florida 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 6 inclusion and 20 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: stopped early, as of the sponsor's last update on 29 Sep 2021. 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.

Are results available for this study?

The study was stopped early (reason given: Cease of Funding). Results are not available in the source record.

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 incisional hernia recurrence (time frame: 2 years from study incisional hernia repair). 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 NCT03034213, which also lists 8 linked publications.

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 29 Sep 2021.

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