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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of biologic meshes used in abdominal wall reconstruction: Strattice (Strattice biologic mesh) and Permacol (Permacol biologic mesh). The researchers aim to evaluate their performance in surgery. Both meshes are made from pig skin but differ in processing methods. The trial seeks adults who need abdominal wall reconstruction surgery and have been recommended for a biologic implant by at least two surgeons. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to significant advancements in surgical care.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Permacol and Strattice biologic meshes have been studied for safety and effectiveness in hernia repairs.

For Permacol, studies indicate it is generally safe for fixing incisional hernias and has been tested for both short-term and long-term use. Some patients have used Permacol for over five years without major problems, though long-term data remains limited.

Strattice has also demonstrated safety for hernia repairs. Research suggests it can effectively support the abdominal wall and has a lower chance of hernia recurrence compared to other meshes. Additionally, Strattice shows similar safety outcomes to synthetic meshes in the early recovery period after surgery.

Overall, current research considers both meshes safe. However, discussing any concerns or questions with a healthcare provider is crucial before deciding to participate in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using biologic meshes like Permacol and Strattice for ventral hernias because they offer innovative support for abdominal wall reconstruction. Unlike synthetic meshes, these biologic options are made from porcine dermis, providing a more natural integration with body tissues. Permacol uses cross-linked porcine dermis, which may enhance durability, while Strattice features noncross-linked porcine dermis, potentially offering better flexibility and tissue growth. These unique features might lead to improved healing and less risk of infection compared to traditional synthetic meshes.

What evidence suggests that this trial's biologic meshes could be effective for ventral hernia?

This trial will compare the effectiveness of Strattice biologic mesh and Permacol biologic mesh for supporting abdominal wall reconstruction in ventral hernia repairs. Research has shown that both Strattice and Permacol are effective options. One study found that Strattice, which participants in one arm of this trial may receive, had a lower infection rate after surgery, with only 5% of patients affected, compared to 21% for Permacol, tested in another arm of this trial. This suggests that Strattice might reduce the risk of infection. However, Permacol remains a good option, with manageable early complications and similar long-term success rates. Both meshes are made from pig skin but are processed differently, which might affect their performance. Overall, both have shown promise in aiding hernia repairs, though they differ in some outcomes like infection rates. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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 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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25264647/

Outcome of abdominal wall hernia repair with biologic mesh Ventral hernia repairs comprised the majority (85% for Permacol, 97% for Strattice™). Postoperative infection rate was lower in the Strattice™ group (5 vs 21%, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1743919119300822

Repair of complex abdominal wall hernias with a cross- ... The aim of this study was to evaluate the indication for the use of cross-linked porcine acellular matrix and to assess the results of CAWHR in potentially ...

3. nature.com nature.com/articles/s41598-020-60019-0

A retrospective, Italian multicenter study of complex ... Our data suggest that Permacol is a feasible strategy to repair a CAWD, with acceptable early complications and long-term (2 year) recurrence rates.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30426186/

Indications and Outcomes of a Cross-Linked Porcine ... Permacol is an acellular porcine dermal collagen matrix with a cross-linked pattern. This study reports short- and long-term outcomes after AWR for incisional ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1743919114000375

A retrospective study evaluating the use of Permacol™ ... The outcome of incisional and ventral hernia repair depends on surgical technique, patient, and material. Permacol™ surgical implant (crosslinked porcine ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3956623/

Porcine dermis implants in soft-tissue reconstruction Porcine dermal meshes have an increasing evidence base regarding their safety, particularly in contaminated or infected fields, but long-term data to support ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1007/s00268-018-4853-x

Indications and Outcomes of a Cross‐Linked Porcine ... Permacol is an acellular porcine dermal collagen matrix with a cross-linked pattern. This study reports short- and long-term outcomes after AWR ...