Biologic Meshes for Ventral Hernia

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Calgary

Disqualifiers: Inability to provide consent

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6-8 weeks

90 Participants Needed

Trial Summary

What is the purpose of this trial?

To date, there have been no prospective randomized controlled trials that compare various biologic mesh materials in the context of abdominal wall reconstruction. As a result, this proposal describes a 'head to head' randomized controlled trial (RCT) between 2 of the market's most popular biologic meshes. Strattice (noncross-linked porcine dermis, LifeCell Inc.) will be compared to Permacol (cross-linked porcine dermis, Covidien Inc.) in a randomized manner. Although there are significant differences between these mesh products with regard to procurement, tissue processing and cost, clinical controlled trials are needed to compare their performance.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Permacol biologic mesh and Strattice biologic mesh for ventral hernia repair?

Research comparing Permacol and Strattice for ventral hernia repair shows that Strattice had a lower postoperative infection rate compared to Permacol. Additionally, biologic meshes like these are often used in complex cases where synthetic meshes are not suitable, suggesting their effectiveness in specific situations. ^{1 2 3 4 5}

Is biologic mesh safe for ventral hernia repair?

Research shows that biologic meshes like Permacol and Strattice have been used in ventral hernia repairs, with Strattice having a lower infection rate compared to Permacol. This suggests that Strattice may be safer in terms of infection risk. ^{1 2 3 4 5}

How does the treatment with Permacol and Strattice biologic meshes for ventral hernia differ from other treatments?

Permacol and Strattice are biologic meshes made from porcine (pig) skin, with Permacol being crosslinked and Strattice non-crosslinked. This difference in crosslinking affects how the body remodels and integrates the mesh, potentially influencing the healing process and infection rates compared to synthetic meshes or other biologic options. ^{1 2 3 6 7}

Eligibility Criteria

This trial is for adults over 18 who need abdominal wall reconstruction and have agreed that a biologic implant is necessary. Two surgeons involved in the trial must concur on this decision. Participants must be able to give informed consent; those who can't will not be eligible.

Inclusion Criteria

Two surgeons agree I need a biologic implant.

I am an adult scheduled for abdominal wall reconstruction.

Exclusion Criteria

Patients unable or unwilling to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo abdominal wall reconstruction using either Strattice or Permacol biologic mesh

6-8 weeks

Weekly visits for monitoring and assessment

Follow-up

Participants are monitored for recurrence and postoperative complications

12 months

Monthly visits for the first 6 months, then bi-monthly

Treatment Details

Interventions

• Permacol biologic mesh
• Strattice biologic mesh

Trial Overview The study compares two popular biologic mesh materials used in abdominal wall reconstructions: Strattice (noncross-linked porcine dermis) and Permacol (cross-linked porcine dermis). Patients are randomly assigned one of these meshes to evaluate their performance.

Participant Groups

Group I: Permacol biologic mesh Experimental Treatment 1 Intervention

Permacol mesh is made of cross-linked porcine dermis, which is used to support abdominal wall reconstruction.

Group II: Strattice biologic mesh Active Control 1 Intervention

Strattice mesh is made of noncross-linked porcine dermis, which is used to support abdominal wall reconstruction.

Permacol biologic mesh is already approved in United States, European Union for the following indications:

Approved in United States as Permacol for:

• Abdominal wall reconstruction
• Hernia repair

Approved in European Union as Permacol for:

• Abdominal wall reconstruction
• Hernia repair

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

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 involving 89 female rats, the cross-linked Permacol™ biologic implant showed greater durability and maintained thickness over time compared to the non-cross-linked Strattice-firm™ tissue matrix, which significantly thinned after 3 months.

The tensile strength of the Permacol™ implant was consistently greater than that of Strattice™ at 3, 6, and 12 months, suggesting that cross-linked biologic implants may offer better long-term performance in hernia repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Permacol™ and Strattice™ for the repair of abdominal wall defects. Mulier, KE., Nguyen, AH., Delaney, JP., et al.[2021]

In a study involving Yucatan minipigs, the crosslinked porcine dermis (Permacol(®)) showed slower early histologic remodeling compared to the non-crosslinked dermis (Strattice(®)), which exhibited faster remodeling in several categories after just one month.

Both types of grafts provided greater tensile strength and stiffness than the native abdominal wall shortly after surgery, but by 12 months, there was no significant difference in strength or stiffness between the grafts and the native tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remodeling characteristics and biomechanical properties of a crosslinked versus a non-crosslinked porcine dermis scaffolds in a porcine model of ventral hernia repair. Cavallo, JA., Greco, SC., Liu, J., et al.[2021]

In a study of 68 patients over 6 years, the recurrence rate of incisional hernias after using biological mesh was alarmingly high at 61.8%, particularly in cases where the anterior fascia was not closed, indicating that proper surgical technique is crucial for reducing recurrence.

Postoperative surgical site infections significantly increased the risk of hernia recurrence (OR=6.2), and using bridged biological mesh was associated with an even higher risk (OR=22.3), suggesting that these factors undermine the effectiveness of biological mesh in hernia repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantation of biologic mesh in ventral hernia repair-does it make sense? Taibi, A., Derbal, S., Durand Fontanier, S., et al.[2021]

In a study involving 48 Yucatan minipigs over 12 months, both crosslinked and non-crosslinked biologic meshes showed similar tensile strengths in hernia repairs, indicating that the type of mesh did not significantly affect the mechanical strength of the repair.

Non-crosslinked meshes demonstrated faster histologic remodeling, including earlier cell infiltration and neovascularization, but by 12 months, many differences between the two types of meshes diminished, suggesting that factors beyond crosslinking may influence long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histologic and biomechanical evaluation of crosslinked and non-crosslinked biologic meshes in a porcine model of ventral incisional hernia repair. Deeken, CR., Melman, L., Jenkins, ED., et al.[2022]

In a study involving 20 Yucatan minipigs, different biologic meshes showed no significant differences in biomechanical strength or integrity at 1 month post-implantation, indicating that the choice of mesh may not affect the immediate repair strength.

Histological analysis revealed that non-crosslinked biologic meshes led to greater cellular infiltration and tissue integration compared to crosslinked meshes, suggesting that non-crosslinked options may promote better healing responses in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early biocompatibility of crosslinked and non-crosslinked biologic meshes in a porcine model of ventral hernia repair. Melman, L., Jenkins, ED., Hamilton, NA., et al.[2022]

In a study involving 194 patients, the new biologic mesh derived from porcine small intestine submucosal (SIS) showed a high recovery rate of 98.97%, comparable to the 100% recovery rate of the standard SIS mesh, indicating similar efficacy in hernia repair.

Both the new and standard SIS meshes demonstrated comparable safety profiles, with no significant differences in complications, recurrence rates, or other clinical outcomes, suggesting that the new mesh is a viable alternative for hernia repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial Of Lichtenstein Repair Of Indirect Inguinal Hernias With Two Biologic Meshes From Porcine Small Intestine Submucosa. Sun, L., Chen, J., Shen, Y.[2022]

References

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

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

2. France pubmed.ncbi.nlm.nih.gov

Comparison of Permacol™ and Strattice™ for the repair of abdominal wall defects. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Remodeling characteristics and biomechanical properties of a crosslinked versus a non-crosslinked porcine dermis scaffolds in a porcine model of ventral hernia repair. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Implantation of biologic mesh in ventral hernia repair-does it make sense? [2021]

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

Histologic and biomechanical evaluation of crosslinked and non-crosslinked biologic meshes in a porcine model of ventral incisional hernia repair. [2022]

6. France pubmed.ncbi.nlm.nih.gov

Early biocompatibility of crosslinked and non-crosslinked biologic meshes in a porcine model of ventral hernia repair. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial Of Lichtenstein Repair Of Indirect Inguinal Hernias With Two Biologic Meshes From Porcine Small Intestine Submucosa. [2022]