What side effects are associated with this type of intervention?

Common treatments for incisional hernia include the use of synthetic, biologic, and biosynthetic meshes. Known side effects of these treatments can include surgical site infections, seroma formation, pain, and hernia recurrence. Specifically, biologic meshes, like those studied in the GORE® ENFORM Biomaterial trial, aim to support tissue regeneration and integration but may still carry risks of infection and recurrence, particularly if used improperly. Synthetic meshes are generally associated with a strong scar plate but can also lead to chronic pain and infection. Overall, while these materials provide structural support and facilitate tissue integration, they are not without potential complications.

What prior FDA approvals exist?

The FDA has approved various materials and devices for the treatment of incisional hernias, focusing on structural support and tissue integration. Notably, synthetic meshes such as polypropylene and polyester, often with anti-adhesive coatings, are commonly used. Additionally, bioabsorbable meshes like the GORE BIO-A Hernia Plug have been approved, providing temporary support while promoting tissue regeneration. These materials aim to reduce recurrence rates and improve patient outcomes by enhancing the integration of the mesh with the surrounding tissue.

What other types of research exist?

Promising alternatives to GORE® ENFORM Biomaterial for incisional hernia repair include Strattice™, a porcine acellular dermal mesh, which has shown significantly lower odds of hernia recurrence compared to other biologic meshes like AlloMax, FlexHD, and Xenmatrix. Additionally, Strattice™ has demonstrated good integration with human tissue and no mesh-related complications in short-term follow-up. Another option is Permacol™, a cross-linked porcine dermis implant, which may offer different remodeling properties compared to non-cross-linked meshes.

← Back to Search

Biomaterial

Gore ENFORM Device for Hernia Repair (ENF 18-06 Trial)

N/A

Recruiting

Led By Todd Heniford, MD

Research Sponsored by W.L.Gore & Associates

Eligibility Criteria Checklist

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

Must have

At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).

An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.

Must not have

Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).

A BMI >35.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a special material called GORE® ENFORM Biomaterial used in hernia repair surgeries. It focuses on patients with specific types of hernias to see how well this material works in real-world conditions. The material helps by acting as a supportive patch during surgery, making the repaired area stronger. GORE® ENFORM Biomaterial is a type of synthetic material used in hernia repair surgeries, known for its effectiveness in providing quick, simple, and effective repair of tissue defects in the abdominal wall.

Who is the study for?

This trial is for adults over 18 with a Grade 1 or 2 ventral or hiatal hernia and a clean surgical wound. Candidates must consent to follow-up, not have a stoma, BMI over 35, systemic infection, cirrhosis/dialysis, be pregnant/lactating, immunocompromised, in another study within the last year or need multiple mesh devices.

What is being tested?

The GORE® ENFORM Biomaterial product's performance is being studied in two groups of patients: those undergoing ventral/incisional hernia repair and those with diaphragmatic/hiatal hernia repair. It's non-randomized and multicenter to collect real-world data on this device.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include discomfort at the implant site, inflammation or infection risk due to foreign material introduction into the body during surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am at least 18 years old or meet my state's age requirement.

Select...

My upcoming surgery is expected to have a low risk of infection.

Select...

I am scheduled for hernia repair with GORE® ENFORM Biomaterial.

Select...

My hernia is mild to moderate according to the VHWS grading.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am getting a hernia repair that requires a device for support.

Select...

My BMI is over 35.

Select...

I have an infection that affects my whole body.

Select...

I have cirrhosis or am undergoing dialysis.

Select...

I have a condition that affects how my wounds heal.

Select...

I have a weakened immune system due to HIV, a transplant, or cancer treatment.

Select...

I am expected to have a mesh implant during my weight loss or excess skin removal surgery.

Select...

I have a stoma.

Select...

I need treatment for hernias in different parts of my body or multiple mesh devices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hernia Recurrence - Primary Device Endpoint

Incidence of SSI - Primary Procedural Endpoint 1

Incidence of SSO - Primary Procedural Endpoint 2

+1 more

Secondary study objectives

Change in Quality of Life in Carolinas Comfort Scale - Secondary Endpoint 3

Freedom from potential device-related SAEs - Secondary endpoint 1

Re-intervention at study-treated location - Secondary Endpoint 2

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Ventral/Incisional Hernia - Preperitoneal ENFORM BiomaterialExperimental Treatment1 Intervention

Group II: Ventral/Incisional Hernia - Intraperitoneal ENFORM BiomaterialExperimental Treatment1 Intervention

Group III: Hiatal/Diaphragmatic Hernia-Intraperitoneal ENFORM BiomaterialExperimental Treatment1 Intervention

Group IV: Hiatal/Diaphragmatic Hernia - Preperitoneal ENFORM BiomaterialExperimental Treatment1 Intervention

0 / 13Eligibility criteria met

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

The most common treatments for incisional hernia include the use of synthetic, biologic, and biosynthetic meshes. These meshes provide structural support to the weakened area of the abdominal wall, preventing the hernia from recurring. Synthetic meshes are durable and offer long-term support, while biologic meshes, such as those studied in the GORE® ENFORM Biomaterial trial, integrate with the patient's tissue, promoting natural healing and reducing the risk of chronic infection. This tissue integration is crucial for incisional hernia patients as it enhances the strength and stability of the repair, leading to better long-term outcomes and fewer complications.

Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial.Biologic prosthetic materials for hernia repairs.