Porcine Acellular Dermal Matrices for Hernia Repair

Overseen By Benjamin Sarac, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jeffrey E Janis, MD

Disqualifiers: Allergy to porcine, Active smokers, Cardiac disease, Pulmonary disease, Renal disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: Surgery day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of biologic meshes, Strattice and XenMatrix, used for hernia repair and abdominal wall reconstruction. Both meshes are made from sterilized pig skin with all cells removed, but each undergoes a different production process. The study will assess the effectiveness of each mesh by evaluating pain, quality of life, and hernia recurrence after surgery. Individuals needing elective hernia repair due to discomfort or risk of complications, who cannot use synthetic mesh, might be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to medical research and potentially benefit from innovative treatment options.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

In earlier studies, XenMatrix has shown promising results for rebuilding the abdominal wall. Patients using XenMatrix reported good outcomes with few serious issues. One study with 74 patients found that XenMatrix was generally well-tolerated, although some patients needed additional surgeries. Importantly, the chance of hernia recurrence was low.

Strattice also has a strong track record. Research has shown it to be safe and effective for supporting the abdominal wall. In a study with 191 patients, Strattice was found to be safe and helped reduce complications after surgery.

Both XenMatrix and Strattice have been used in surgeries and are approved by the FDA, which supports their safety. While no treatment is without risk, evidence suggests these meshes are generally safe and reliable options for hernia repair. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Strattice and XenMatrix for hernia repair because these treatments utilize porcine acellular dermal matrices, which are designed to integrate seamlessly with human tissue. Unlike synthetic mesh, which is the standard treatment option, these biologic materials are derived from pig tissue, offering the potential for reduced inflammation and better tissue regeneration. Additionally, this approach may lower the risk of infection and complications often associated with traditional synthetic meshes, making these options promising alternatives for improving patients' recovery and quality of life.

What evidence suggests that this trial's treatments could be effective for hernia repair?

This trial will compare the effectiveness of Strattice and XenMatrix for hernia repair. Studies have shown that both Strattice and XenMatrix effectively repair hernias and rebuild the abdominal wall. Specifically, research found that XenMatrix had a low hernia recurrence rate of 5.8% over two years, with patients reporting a good quality of life. Strattice is well tolerated and provides strong support to the abdominal wall, showing moderate success with better hernia recurrence rates in some cases. Both products, approved by the FDA, are made from pig skin with cells removed and sterilized to ensure safety. ^{2 4 5 6 7}

Who Is on the Research Team?

Jeffrey E Janis, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

Adults over 18 needing elective hernia repair or abdominal wall tumor resection, who can't use synthetic mesh due to health issues or contamination. They should be in good health without severe heart, lung, kidney, or blood diseases and not in an emergency situation like bowel strangulation.

Inclusion Criteria

I am older than 18 years.

I am considered fit for surgery and do not have severe heart, lung, kidney, or blood diseases.

I am having elective hernia repair, have a VHWG grade 2 or higher, and cannot use synthetic mesh due to other health issues or contamination.

Exclusion Criteria

I do not have severe heart, lung, kidney, or blood diseases and am seeking elective hernia repair.

I am here for an urgent hernia repair.

Known allergy to porcine products

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-3 weeks

1 visit (in-person)

Preoperative Assessment

Assess pain intensity, pain interference, physical functioning, and quality of life at the last office visit before surgery

1-3 weeks

1 visit (in-person)

Treatment

Abdominal wall reconstruction with either XenMatrix or Strattice mesh

Surgery day

1 visit (in-person)

Postoperative Monitoring

Assess hernia recurrence, bulge, and surgical site occurrences at 30 days postoperatively

30 days

1 visit (in-person)

Follow-up

Assess overall complications, pain intensity, pain interference, physical functioning, quality of life, hernia recurrence, bulge, and surgical site occurrences at 1 year postoperatively

1 year

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Strattice
• XenMatrix

Trial Overview The trial is comparing two FDA-approved biologic meshes (Strattice and XenMatrix) used for hernia repairs and abdominal reconstructions. These meshes are made from pig skin that's been treated to remove cells and sterilized but produced by different companies.

How Is the Trial Designed?

Group I: XenMatrix Experimental Treatment 18 Interventions

Abdominal wall reconstruction with XenMatrix Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively

Group II: Strattice Experimental Treatment 18 Interventions

Abdominal wall reconstruction with Strattice Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively

Strattice is already approved in United States, European Union for the following indications:

Approved in United States as Strattice for:

• Ventral hernia repair
• Soft tissue reinforcement
• Body wall defects

Approved in European Union as Strattice for:

• Ventral hernia repair
• Soft tissue reinforcement
• Body wall defects

Who Is Running the Clinical Trial?

Jeffrey E Janis, MD

Lead Sponsor

Trials

1

Recruited

70+

Jeffrey Janis

Lead Sponsor

Trials

1

Recruited

70+

Published Research Related to This Trial

The study successfully processed porcine dermal tissue to create an acellular graft that minimizes immune response by reducing alpha-Gal antigens, which is crucial for better integration into host tissue.

In an Old World primate model, the grafts showed good tolerance with no signs of inflammation, and significant cellular repopulation and vascularization occurred as early as 2 weeks post-implantation, indicating effective tissue regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retention of structural and biochemical integrity in a biological mesh supports tissue remodeling in a primate abdominal wall model. Connor, J., McQuillan, D., Sandor, M., et al.[2022]

In a study involving 40 rabbits, the rifampin/minocycline-coated acellular porcine dermal matrix (XenMatrix AB) completely prevented bacterial colonization and abscess formation when compared to the uncoated Strattice matrix after inoculation with methicillin-resistant Staphylococcus aureus and E. coli.

XenMatrix AB not only inhibited bacterial growth but also resulted in significantly lower inflammation and encapsulation, promoting better healing and neovascularization compared to Strattice, indicating its potential as a superior antimicrobial bioprosthetic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Antibiotic-Coated versus Uncoated Porcine Dermal Matrix. Cohen, LE., Imahiyerobo, TA., Scott, JR., et al.[2022]

In a study involving New Zealand White rabbits, three types of noncrosslinked porcine dermal collagen biomeshes were evaluated for their effectiveness in abdominal wall reconstruction, with Strattice™ showing the best results in terms of collagenization and tensile strength.

All biomeshes were safe with no mortality or infection reported, but Strattice™ exhibited superior host tissue incorporation and minimal foreign body reaction compared to the other meshes, while XCM had a higher macrophage response at 90 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remodeling of Noncrosslinked Acellular Dermal Matrices in a Rabbit Model of Ventral Hernia Repair. Pascual, G., Sotomayor, S., Adel, F., et al.[2016]

In a study using a human skin organ culture model, Strattice, a porcine reconstructive tissue matrix, allowed for better horizontal resurfacing of skin compared to Matriderm, although it delayed vertical cellular ingrowth.

Strattice showed no increase in cellular inflammation and may provide prolonged biomechanical stability, making it a suitable option for dermal replacement in areas with high mechanical load requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete horizontal skin cell resurfacing and delayed vertical cell infiltration into porcine reconstructive tissue matrix compared to bovine collagen matrix and human dermis. Mirastschijski, U., Kerzel, C., Schnabel, R., et al.[2021]

In a study of 82 patients undergoing immediate implant-based breast reconstruction, SurgiMend showed significantly lower rates of acellular dermal matrix loss and reoperation compared to Strattice, suggesting better clinical outcomes with SurgiMend.

Although the implant loss rate was higher for Strattice (20%) compared to SurgiMend (7%), this difference did not reach statistical significance, indicating a trend that may warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Comparison of Strattice and SurgiMend in Acellular Dermal Matrix-Assisted, Implant-Based Immediate Breast Reconstruction. Mazari, FAK., Wattoo, GM., Kazzazi, NH., et al.[2021]

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 rabbit model for incisional hernia repair, human acellular dermal matrices (HADM) demonstrated significantly faster tissue ingrowth and better healing outcomes compared to porcine acellular dermal matrices (PADM), with 54% vs. 16% tissue ingrowth at 4 weeks and 58% vs. 20% at 20 weeks.

HADM also resulted in a smaller unremodeled area (1.0 cm²) compared to PADM (2.7 cm²) at 20 weeks, indicating superior effectiveness in repairing abdominal wall defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of human acellular dermis versus porcine acellular dermis in an in vivo model for incisional hernia repair. Ngo, MD., Aberman, HM., Hawes, ML., et al.[2022]

Acellularized porcine dermis was found to be less effective than human acellularized dermis as a scaffold for human fibroblasts, with only 31% of pig samples showing fibroblast infiltration compared to 83% for human samples.

While fibroblasts proliferated more rapidly on pig acellularized dermis, they migrated less effectively compared to those on human acellularized dermis, indicating that the interaction between fibroblasts and the matrix differs significantly between the two materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of human and porcine acellularized dermis: interactions with human fibroblasts in vitro. Armour, AD., Fish, JS., Woodhouse, KA., et al.[2022]

In a case series of three patients with poor quality mammary soft-tissue support, the use of porcine-derived acellular dermal matrix during breast augmentation resulted in no post-operative complications over an average follow-up of 18 months.

All patients reported positive outcomes and high satisfaction with their aesthetic results, suggesting that this technique may enhance soft-tissue support and reduce risks associated with breast implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Porcine-derived acellular dermal matrix in primary augmentation mammoplasty to minimize implant-related complications and achieve an internal mastopexy: a case series. Kornstein, A.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3829067/

Critical Analysis of Strattice Performance in Complex ... Strattice appears to be clinically well tolerated and provides support to the abdominal wall in patients at intermediate risk for postoperative complications.

2. hcp.stratticetissuematrix.com hcp.stratticetissuematrix.com/

Healthcare Professional Official Site STRATTICE ... STRATTICE™ Reconstructive Tissue Matrix (RTM) is a porcine-derived acellular dermal matrix that has demonstrated efficacy in the reinforcement of abdominal wall ...

3. journals.lww.com journals.lww.com/prsgo/fulltext/2013/12000/bioprosthetic_tissue_matrices_in_complex_abdominal.2.aspx

Bioprosthetic Tissue Matrices in Complex Abdominal Wall... The clinical efficacy of Strattice in abdominal wall reconstruction has demonstrated moderate success in several studies; however, long-term outcomes are ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02587403

A Comparison of Fortiva and Strattice Tissue Matrices in ... The objective of this study is to compare the effectiveness of Fortiva Porcine Dermis versus Strattice Reconstructive Tissue Matrix for the underlay ...

5. hcp.stratticetissuematrix.com hcp.stratticetissuematrix.com/-/media/unique-sites/strattice/documents/STM107299_Garvey%20Evidence%20Matters%20sheet%20update.pdf

In the study, STRATTICE™ Reconstructive Tissue Matrix (RTM ... Long-term outcomes after abdominal wall reconstruction with acellular dermal ... These data demonstrated that hernia recurrence rates can be even improved ...

6. hcp.stratticetissuematrix.com hcp.stratticetissuematrix.com/en/products

for various applications to meet your hernia repair needs. Learn about the STRATTICE Reconstructive Tissue Matrix portfolio of products. See Safety Informationand full Instructions for Use.

7. hcp.stratticetissuematrix.com hcp.stratticetissuematrix.com/-/media/unique-sites/strattice/documents/STM125614_Garvey%20Evidence%20Matters%20Sheet%20Update.pdf

because evidence matters - Strattice™ Tissue Matrix Study Setup. • Analysis sample of 191 patients, with a median follow-up of 52.9 months (range 36-104 months) and. 23 surgeons. Majority of nonhuman ADMs ...