Fortiva vs Strattice Mesh for Hernia Repair

Overseen By Gregory T Scarola, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the hernia repair trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Fortiva and Strattice for hernia repair?

Research shows that Strattice, a type of biologic mesh, is effective in hernia repair as it integrates well with human tissue, supports tissue regeneration, and has a lower infection rate compared to some other biologic meshes. It also demonstrates resistance to rejection and can support skin grafts, making it a promising option for complex hernia repairs. ^{1 2 3 4 5}

Is Strattice mesh safe for hernia repair in humans?

Strattice mesh has been shown to integrate well with human tissue, even in challenging wound conditions, and is generally resistant to rejection. In studies, it demonstrated a low rate of complications like infection and was effective in achieving abdominal wall closure, even in patients with multiple health issues. ^{3 5 6 7 8}

How does the Fortiva treatment for hernia repair differ from other treatments?

Fortiva is a type of biologic mesh made from porcine (pig) dermis, which is designed to integrate with the body's tissues more naturally than synthetic meshes. This treatment is unique because it is non-cross-linked, meaning it retains more of its natural properties, potentially leading to better tissue integration and reduced risk of complications compared to synthetic options. ^{2 3 5 9 10}

Research Team

Todd Heniford, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

Inclusion Criteria

I need surgery for a hernia in my abdomen.

Exclusion Criteria

Pregnant women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ventral hernia repair using Fortiva biologic mesh

1-2 weeks

Follow-up

Participants are monitored for hernia recurrence and mesh-related complications

1 year

Treatment Details

Interventions

• Fortiva
• Strattice

Trial Overview 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.

Participant Groups

Group I: Prospective Experimental Treatment 1 Intervention

Participants enrolled to ventral hernia repair with Fortiva mesh

Group II: Retrospective Active Control 1 Intervention

Retrospective participants with ventral hernia repair using Strattice mesh

Fortiva is already approved in United States for the following indications:

Approved in United States as Fortiva for:

• Abdominal Wall Reconstruction
• Hernia Repair

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

This study is a randomized, controlled trial involving 172 men to compare the safety and effectiveness of a biologic graft (Strattice) versus a synthetic mesh (UltraPro) in inguinal hernia repair, with a follow-up period of at least 2 years.

The primary goal is to assess how quickly patients can return to normal activities post-surgery, while secondary outcomes include chronic pain, complications, and re-herniation rates at 12 and 24 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair. Bellows, CF., Shadduck, PP., Helton, WS., et al.[2021]

Strattice, a non-cross-linked acellular porcine dermal matrix, has been successfully used as a graft for reconstructing fascial defects in a case of symptomatic upper limb muscle herniation, offering a new treatment option.

Using Strattice avoids the complications associated with human donor tissue, while still providing suitable tensile properties for effective reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed repair in a case of forearm fascial muscle herniation using non-cross-linked acellular porcine dermal matrix. Hartmann, CE., Branford, OA., Floyd, D.[2022]

In a study of 11 high-risk patients undergoing ventral hernia repair with Strattice™ (a non-cross-linked porcine acellular dermal matrix), 91% showed clinical evidence of vascularization, indicating its potential to integrate with human tissue even in challenging wound conditions.

Histological analysis of one patient revealed neovascularization and collagen remodeling three months post-surgery, suggesting that Strattice™ is resistant to rejection and can effectively support healing in complex abdominal wall reconstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Porcine acellular dermal matrix (PADM) vascularises after exposure in open necrotic wounds seen after complex hernia repair. Gowda, AU., Chang, SM., Chopra, K., et al.[2021]

In a study involving 15 swine, the bioprosthetic material Permacol showed superior properties for ventral hernia repair, including lower inflammation, reduced adhesion rates, and better biomechanical strength compared to DermaMatrix and AlloDerm.

All tested materials resulted in no hernia recurrence, but DermaMatrix and AlloDerm had higher adhesion and inflammation, suggesting that while they are effective, Permacol may be the more favorable option for long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal ventral hernia repair with current biological prostheses: an experimental large animal model. Stanwix, MG., Nam, AJ., Hui-Chou, HG., et al.[2011]

In a study of 270 patients undergoing abdominal wall hernia repair, Strattice™ mesh showed a significantly lower postoperative infection rate (5%) compared to Permacol™ mesh (21%), indicating better safety outcomes for Strattice™.

While both meshes had similar hernia recurrence rates, the overall complication rates were higher in the Permacol™ group, especially in patients with infected wounds and those who were obese, suggesting that Strattice™ may be a safer option for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of abdominal wall hernia repair with biologic mesh: Permacol™ versus Strattice™. Cheng, AW., Abbas, MA., Tejirian, T.[2022]

In a study of 41 intermediate-risk patients undergoing complex abdominal wall reconstruction using Strattice, 97.6% achieved successful fascial closure, demonstrating the efficacy of this porcine-derived acellular dermal matrix.

Despite the patients' multiple comorbidities, the procedure was safe, with no recurrent hernias or need for Strattice removal, and only a low incidence of complications such as seroma (7.3%) and wound dehiscence (4.9%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical analysis of Strattice performance in complex abdominal wall reconstruction: intermediate-risk patients and early complications. Patel, KM., Albino, FP., Nahabedian, MY., et al.[2022]

In a study of 116 patients over 5 years, the use of porcine small intestinal submucosa mesh (Surgisis) for hernia repairs in potentially contaminated fields showed a low recurrence rate of only 7 cases, indicating its efficacy in challenging surgical conditions.

The mesh was found to be well-integrated into the tissue during follow-up, with minimal complications such as seromas and mild pain, suggesting that it is a safe option for hernia repairs in infected or contaminated settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow-up. Franklin, ME., Treviño, JM., Portillo, G., et al.[2022]

The study compared two bioactive meshes, Surgisis Gold and Alloderm, in 74 patients undergoing ventral hernia repair, revealing that the non-perforated Surgisis mesh had a high rate of seroma formation (10 out of 11 patients), while the perforated version reduced this complication significantly (3 out of 30 patients).

Alloderm mesh was associated with higher rates of hernia recurrence (8 cases) and post-operative bulging (15 cases), indicating that while both mesh types have their issues, the complications differ and further design improvements are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventral herniorrhaphy: experience with two different biosynthetic mesh materials, Surgisis and Alloderm. Gupta, A., Zahriya, K., Mullens, PL., et al.[2022]

Strattice acellular dermal matrix (ADM) demonstrated superior mechanical strength and retention of native properties compared to SurgiMend, with Strattice maintaining 33.44% to 65.65% of its initial strength after collagenase exposure, while SurgiMend was completely digested within 48 hours.

Strattice also showed a greater fibroblast repopulation and minimal inflammatory response after 6 weeks of implantation, indicating better integration with host tissue, which is crucial for effective abdominal wall reconstruction and reducing hernia recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular Dermal Matrix Susceptibility to Collagen Digestion: Effect on Mechanics and Host Response. Stec, E., Lombardi, J., Augustin, J., et al.[2023]

In a study of 229 patients undergoing abdominal wall reconstruction, the use of acellular dermal matrices (ADMs) showed lower hernia recurrence rates, with Fortiva having the best performance at 6.9% compared to Strattice at 11.2% and Alloderm at 22.0%.

Fortiva also demonstrated a significantly lower rate of seroma formation at 1.4%, indicating a potentially safer profile compared to the other ADMs, which had surgical site occurrences around 49-57%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Acellular Dermal Matrices in Abdominal Wall Reconstruction. Maxwell, DW., Hart, AM., Keifer, OP., et al.[2022]

References

1. France pubmed.ncbi.nlm.nih.gov

The design of an industry-sponsored randomized controlled trial to compare synthetic mesh versus biologic mesh for inguinal hernia repair. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Delayed repair in a case of forearm fascial muscle herniation using non-cross-linked acellular porcine dermal matrix. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Porcine acellular dermal matrix (PADM) vascularises after exposure in open necrotic wounds seen after complex hernia repair. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Abdominal ventral hernia repair with current biological prostheses: an experimental large animal model. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

Outcome of abdominal wall hernia repair with biologic mesh: Permacol™ versus Strattice™. [2022]

6. Italy pubmed.ncbi.nlm.nih.gov

Critical analysis of Strattice performance in complex abdominal wall reconstruction: intermediate-risk patients and early complications. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

The use of porcine small intestinal submucosa as a prosthetic material for laparoscopic hernia repair in infected and potentially contaminated fields: long-term follow-up. [2022]

8. France pubmed.ncbi.nlm.nih.gov

Ventral herniorrhaphy: experience with two different biosynthetic mesh materials, Surgisis and Alloderm. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Acellular Dermal Matrix Susceptibility to Collagen Digestion: Effect on Mechanics and Host Response. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Acellular Dermal Matrices in Abdominal Wall Reconstruction. [2022]