Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03034213
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
ACell Inc.
Information provided by (Responsible Party):
University of South Florida

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.

Condition or disease Intervention/treatment Phase
Ventral Incisional Hernia Device: Gentrix™ Surgical Matrix (Treatment) Device: Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Treatment
Gentrix(TM) Surgical Matrix
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.

Active Comparator: Control
Standard of care mesh
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.




Primary Outcome Measures :
  1. Incidence of incisional hernia recurrence [ Time Frame: 2 years from study incisional hernia repair ]

Secondary Outcome Measures :
  1. Time to incisional hernia recurrence [ Time Frame: 2 years from study incisional hernia repair ]
  2. 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

  3. Incidence of enterocutaneous fistula formation [ Time Frame: 2 years from study incisional hernia repair ]
  4. Mean Carolinas Comfort Scale score [ Time Frame: 2 years from study incisional hernia repair ]
    Patient-centered outcome

  5. Mean Visual Analog Scale score [ Time Frame: 2 years from study incisional hernia repair ]
    Patient-centered outcome

  6. Mean mesh deployment time [ Time Frame: duration of surgery (incisional hernia repair) ]
    Defined as the time mesh preparation starts to time mesh placement ends

  7. Mean procedure time [ Time Frame: duration of surgery (incisional hernia repair) ]
    Defined as time of incision to time of closure

  8. Mean total cost of hospitalization for primary admission [ Time Frame: duration of hospitalization for incisional hernia repair ]
    Defined as from surgery to hospital discharge

  9. Mean total cost of surgery for primary admission [ Time Frame: duration of surgery (incisional hernia repair) ]
    Defined as from preoperative preparation to anesthesia discharge

  10. 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

  11. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034213


Contacts
Layout table for location contacts
Contact: Thanh Tran, MPH 813-844-8544 thanhtran@health.usf.edu
Contact: Rachel Karlnoski, PhD 813-844-4133 rkarlnos@health.usf.edu

Locations
Layout table for location information
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Beth Montera, NRCMA    813-844-7948    bmontera@health.usf.edu   
Contact: Rachel Karlnoski, PhD    813-844-4133    rkarlnos@health.usf.edu   
Principal Investigator: Vic Velanovich, MD         
Sub-Investigator: Michael Albrink, MD         
Sub-Investigator: Donald Davis, MD         
Sub-Investigator: Adham Saad, MD         
University of South Florida - South Tampa Campus Recruiting
Tampa, Florida, United States, 33606
Contact: Beth Montera, NRCMA    813-844-7948    bmontera@health.usf.edu   
Contact: Rachel Karlnoski, PhD    813-844-4133    rkarlnos@health.usf.edu   
Principal Investigator: Vic Velanovich, MD         
Sub-Investigator: Michael Albrink, MD         
Sub-Investigator: Donald Davis, MD         
Sub-Investigator: Adham Saad, MD         
University of South Florida Morsani Center for Advanced Health Care Recruiting
Tampa, Florida, United States, 33612
Contact: Beth Montera, NRCMA    813-844-7948    bmontera@health.usf.edu   
Contact: Rachel Karlnoski, PhD    813-844-4133    rkarlnos@health.usf.edu   
Principal Investigator: Vic Velanovich, MD         
Sub-Investigator: Michael Albrink, MD         
Sub-Investigator: Donald Davis, MD         
Sub-Investigator: Adham Saad, MD         
Sponsors and Collaborators
University of South Florida
ACell Inc.
Investigators
Layout table for investigator information
Principal Investigator: Vic Velanovich, MD University of South Florida

Publications of Results:

Other Publications:
Layout table for additonal information
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03034213     History of Changes
Other Study ID Numbers: CA2017-002
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of South Florida:
mesh

Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes