Gentrix™ Versus Biological or Prosthetic Mesh

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.

Study Overview

• Status: Terminated
• Conditions: Ventral Incisional Hernia
• Intervention / Treatment: Device: Gentrix™ Surgical Matrix (Treatment); Device: Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)

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: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • Tampa, Florida, United States, 33606
      • University of South Florida - South Tampa Campus
    • Tampa, Florida, United States, 33612
      • University of South Florida Morsani Center for Advanced Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of incisional hernia recurrence	2 years from study incisional hernia repair

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to incisional hernia recurrence		2 years from study incisional hernia repair
Incidence of wound complications	Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation	90 days from study incisional hernia repair
Incidence of enterocutaneous fistula formation		2 years from study incisional hernia repair
Mean Carolinas Comfort Scale score	Patient-centered outcome	2 years from study incisional hernia repair
Mean Visual Analog Scale score	Patient-centered outcome	2 years from study incisional hernia repair
Mean mesh deployment time	Defined as the time mesh preparation starts to time mesh placement ends	duration of surgery (incisional hernia repair)
Mean procedure time	Defined as time of incision to time of closure	duration of surgery (incisional hernia repair)
Mean total cost of hospitalization for primary admission	Defined as from surgery to hospital discharge	duration of hospitalization for incisional hernia repair
Mean total cost of surgery for primary admission	Defined as from preoperative preparation to anesthesia discharge	duration of surgery (incisional hernia repair)
Mean total cost of narcotic usage for primary admission	Defined as narcotic use from surgery to hospital discharge	duration of hospitalization for incisional hernia repair
Mean total cost of readmissions	Defined as any hospital readmissions related to ventral hernia complications or recurrence	2 years from study incisional hernia repair

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: Integra LifeSciences Corporation

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 6, 2017
• Primary Completion (ACTUAL): June 16, 2021
• Study Completion (ACTUAL): June 16, 2021

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (ESTIMATE): January 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: mesh
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: CA2017-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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