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Gentrix™ Versus Biological or Prosthetic Mesh

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03034213
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : March 2, 2020
Sponsor:
Collaborator:
ACell Inc.
Information provided by (Responsible Party):
University of South Florida

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date March 2, 2020
Actual Study Start Date  ICMJE October 6, 2017
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
Incidence of incisional hernia recurrence [ Time Frame: 2 years from study incisional hernia repair ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2017)
  • Time to incisional hernia recurrence [ Time Frame: 2 years from study incisional hernia repair ]
  • Incidence of wound complications [ Time Frame: 90 days from study incisional hernia repair ]
    Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation
  • Incidence of enterocutaneous fistula formation [ Time Frame: 2 years from study incisional hernia repair ]
  • Mean Carolinas Comfort Scale score [ Time Frame: 2 years from study incisional hernia repair ]
    Patient-centered outcome
  • Mean Visual Analog Scale score [ Time Frame: 2 years from study incisional hernia repair ]
    Patient-centered outcome
  • Mean mesh deployment time [ Time Frame: duration of surgery (incisional hernia repair) ]
    Defined as the time mesh preparation starts to time mesh placement ends
  • Mean procedure time [ Time Frame: duration of surgery (incisional hernia repair) ]
    Defined as time of incision to time of closure
  • Mean total cost of hospitalization for primary admission [ Time Frame: duration of hospitalization for incisional hernia repair ]
    Defined as from surgery to hospital discharge
  • Mean total cost of surgery for primary admission [ Time Frame: duration of surgery (incisional hernia repair) ]
    Defined as from preoperative preparation to anesthesia discharge
  • Mean total cost of narcotic usage for primary admission [ Time Frame: duration of hospitalization for incisional hernia repair ]
    Defined as narcotic use from surgery to hospital discharge
  • Mean total cost of readmissions [ Time Frame: 2 years from study incisional hernia repair ]
    Defined as any hospital readmissions related to ventral hernia complications or recurrence
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • Time to incisional hernia recurrence [ Time Frame: 2 years from study incisional hernia repair ]
  • Incidence of wound complications [ Time Frame: 90 days from study incisional hernia repair ]
    Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation
  • Incidence of enterocutaneous fistula formation [ Time Frame: 2 years from study incisional hernia repair ]
  • Mean Carolinas Comfort Scale score [ Time Frame: 2 years from study incisional hernia repair ]
    Patient-centered outcome
  • Mean Wong Bakers Visual Pain Scale score [ Time Frame: 2 years from study incisional hernia repair ]
    Patient-centered outcome
  • Mean mesh deployment time [ Time Frame: duration of surgery (incisional hernia repair) ]
    Defined as the time mesh preparation starts to time mesh placement ends
  • Mean procedure time [ Time Frame: duration of surgery (incisional hernia repair) ]
    Defined as time of incision to time of closure
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gentrix™ Versus Biological or Prosthetic Mesh
Official Title  ICMJE Randomized, Controlled Trial Comparing Separation of Components Repair With Retrorectus Gentrix™ Surgical Matrix Versus Biological or Prosthetic Mesh for Open Ventral Hernia Repair
Brief 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 reinforced with other prosthetic or biologically-derived mesh.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ventral Incisional Hernia
Intervention  ICMJE
  • Device: Gentrix™ Surgical Matrix (Treatment)
    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.
  • Device: Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)
    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 Arms  ICMJE
  • Active Comparator: Treatment
    Gentrix(TM) Surgical Matrix
    Intervention: Device: Gentrix™ Surgical Matrix (Treatment)
  • Active Comparator: Control
    Standard of care mesh
    Intervention: Device: Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 27, 2020)
17
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
120
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034213
Other Study ID Numbers  ICMJE CA2017-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of South Florida
Study Sponsor  ICMJE University of South Florida
Collaborators  ICMJE ACell Inc.
Investigators  ICMJE
Principal Investigator: Vic Velanovich, MD University of South Florida
PRS Account University of South Florida
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP