What is the mechanism of action of this treatment?

Biologic mesh, such as Fortiva and Strattice, is commonly used in ventral hernia repair to provide structural support to the abdominal wall. These meshes are derived from natural tissues and are designed to integrate with the patient's own tissue, promoting tissue regeneration and reducing the risk of rejection. The primary mechanism of action involves reinforcing the weakened area of the abdominal wall, thereby preventing hernia recurrence. This is particularly important for ventral hernia patients as it offers a durable repair with potentially fewer complications compared to synthetic meshes, especially in contaminated or complex surgical fields.

What side effects are associated with this type of intervention?

The most common treatments for ventral hernia, particularly those involving biologic mesh such as Strattice and Fortiva, include surgical repair with mesh reinforcement. Known side effects of these treatments can include hernia recurrence, surgical site infections, seroma formation, and bulging at the repair site. While biologic meshes are designed to integrate with the body's tissues and reduce complications, they still carry risks similar to other mesh types, including infection and recurrence. Additionally, minimally invasive techniques may have lower complication rates but require further study to confirm their long-term effectiveness.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for biologic mesh used in the treatment of ventral hernia. However, it does discuss the use of biologic meshes like Fortiva and Strattice in clinical trials comparing their effectiveness and complication rates. These meshes are used to provide structural support to the abdominal wall during hernia repair, particularly in cases with contamination or higher severity of premorbid conditions.

What other types of research exist?

Promising alternatives to biologic mesh for ventral hernia repair include synthetic long-term resorbable meshes such as poly-4-hydroxybutyrate (P4HB) mesh, which has shown positive outcomes in high-risk patients. Additionally, biosynthetic meshes that combine properties of both synthetic and biologic materials are being explored for their potential to provide durable support while minimizing complications. Techniques such as robotic-assisted laparoscopic repair are also gaining traction for their precision and reduced recovery times.

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Biologic Mesh

Fortiva vs Strattice Mesh for Hernia Repair

N/A

Recruiting

Led By Todd Heniford, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year follow up post surgical repair

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two types of surgical mesh, Fortiva and Strattice, used to repair belly hernias. It aims to see which mesh is better at preventing hernias from coming back and causing fewer complications. The study involves patients who need hernia repair surgery and matches them based on age, sex, and hernia size.

Who is the study for?

This trial is for individuals who need surgery to repair a ventral hernia, which is a bulge of tissues through an opening within abdominal muscles. Pregnant women are not eligible to participate.

What is being tested?

The study compares two types of mesh used in hernia repair surgeries: Fortiva and Strattice. It looks at how often the hernia comes back after using each mesh and what complications might arise with each type.

What are the potential side effects?

While specific side effects aren't listed, common ones from hernia mesh may include pain, infection, hernia recurrence, adhesion (tissue sticking together), and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year follow up post surgical repair

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year follow up post surgical repair

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year follow up post surgical repair for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of participants with a Hernia recurrence

Percent of participants with a Hernia recurrence

Secondary study objectives

Frequency of participants with a Mesh related complication

Percent of participants with a Mesh related complication

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ProspectiveExperimental Treatment1 Intervention

Participants enrolled to ventral hernia repair with Fortiva mesh

Group II: RetrospectiveActive Control1 Intervention

Retrospective participants with ventral hernia repair using Strattice mesh

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Biologic mesh, such as Fortiva and Strattice, is commonly used in ventral hernia repair to provide structural support to the abdominal wall. These meshes are derived from natural tissues and are designed to integrate with the patient's own tissue, promoting tissue regeneration and reducing the risk of rejection. The primary mechanism of action involves reinforcing the weakened area of the abdominal wall, thereby preventing hernia recurrence. This is particularly important for ventral hernia patients as it offers a durable repair with potentially fewer complications compared to synthetic meshes, especially in contaminated or complex surgical fields.

Hernia recurrence and infection rate in elective complex abdominal wall repair using biologic mesh.Role of tissue expansion in abdominal wall reconstruction: A systematic evidence-based review.