Observational Biologic or Prosthetic Mesh

Study Overview
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Brief Summary
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The purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair.

Detailed Description
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Incisional hernias are very common, leading to over 380,000 operative repairs done annually. Despite the commonality of this problem, there has been no single operative repair that has become the standard. This is due to the high recurrence rates with all types of repairs, especially primary suture repair. Because of this, most repairs are done with some type of mesh, either made out of a prosthetic material or biologic material. Mesh repairs, however, have their own problems, namely surgical site infections and potential bowel erosion. 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. To address these mesh related complications, the separation of components technique was developed to reduce tension on the midline repair and the underlay technique was developed to place the mesh in the retrorectus space. Nevertheless, this technique still has a significant recurrence rate. Therefore, the purpose of this study is to evaluate the effectiveness of biological or prosthetic mesh in incisional hernia repair, by assessing the associated rates of hernia recurrence and complications.

Official Title
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Prospective, Observational Trial of Biological or Prosthetic Mesh for Open Ventral Hernia Repair

Conditions
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Ventral Incisional Hernia

Intervention / Treatment
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* Device: Mesh for hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients > 21 years old. 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. Exclusion Criteria: 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, prosthetic or biological meshes, or personal preference. Male and female patients ≤ 21 years old 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.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of care<br>Mesh for hernia repair: Standard of care products used by the Investigator for open ventral hernia repair procedure | Device: Mesh for hernia repair<br>* Permacol, Parietex, Progrip, Strattice Perforated, and Surgimend.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ventral hernia recurrence |  | 2 years from study ventral hernia repair | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to ventral hernia recurrence |  | 2 years from study ventral hernia repair | 
| Incidence of wound complications | Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation | 90 days from study ventral hernia repair | 
| Incidence of enterocutaneous fistula formation |  | 2 years from study ventral hernia repair | 
| Mean Carolinas Comfort Scale score | Patient-centered outcome assessing hernia symptoms - minimum score 0 and maximum total score 115 | 2 years from study ventral hernia repair | 
| Mean Visual Analog Scale score | Patient-centered outcome - pain score measured by a line in millimeters (0 for no pain and 10 for worst pain imaginable) | 2 years from study ventral hernia repair | 
| Mean mesh deployment time | Defined as the time mesh preparation starts to time mesh placement ends | during surgery | 
| Mean procedure time | Defined as time of incision to time of closure | during surgery | 
| Mean total cost of hospitalization for primary admission | Defined as cost from surgery to hospital discharge | From date of surgery to date of hospital discharge (approximately 3 days) | 
| Mean total cost of surgery for primary admission | Defined as cost from preoperative preparation to anesthesia discharge | during surgery | 
| Mean total cost of narcotic usage for primary admission | Defined as cost from narcotic use from surgery to hospital discharge | From date of surgery to date of hospital discharge (approximately 3 days) | 
| Mean total cost of readmissions | any hospital readmissions related to ventral hernia complications or recurrence | 2 years from study ventral hernia repair | 

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