Gentrix™ Versus Biological or Prosthetic Mesh

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventral Incisional Hernia

Intervention / Treatment
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* Device: Gentrix™ Surgical Matrix (Treatment)
* Device: Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Gentrix(TM) Surgical Matrix | Device: Gentrix™ Surgical Matrix (Treatment)<br>* 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.<br>|
| Active Comparator: Control<br>Standard of care mesh | Device: Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mesh