Porcine Acellular Dermal Matrices for Hernia Repair

Recruiting in Palo Alto (17 mi)

Overseen by Jeffrey E Janis, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Jeffrey E Janis, MD

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.

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 porcine acellular dermal matrix safe for use in humans?

Studies on porcine acellular dermal matrices like Strattice show they are generally safe for use in humans, with some complications such as seroma (fluid buildup), wound issues, and minor infections reported. These materials have been used successfully in various surgeries, including hernia repair and breast augmentation, without the need for removal or recurrence of issues. ^{1 2 3 4 5}

How is the treatment Strattice and XenMatrix unique for hernia repair?

Strattice and XenMatrix are unique for hernia repair because they use porcine (pig-derived) acellular dermal matrices, which are designed to integrate with the body's tissues and minimize immune response. This approach differs from traditional synthetic meshes by providing a natural scaffold that supports tissue regeneration and healing. ^{1 6 7 8 9}

Research Team

Jeffrey E Janis, MD

Principal Investigator

Ohio State University

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Strattice (Acellular Dermal Matrix)
• XenMatrix (Acellular Dermal Matrix)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

Jeffrey E Janis, MD

Lead Sponsor

Trials

1

Recruited

70+

Jeffrey Janis

Lead Sponsor

Trials

1

Recruited

70+

Findings from Research

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]

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 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 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]

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]

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]

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 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]

References

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

Comparison of Antibiotic-Coated versus Uncoated Porcine Dermal Matrix. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Remodeling of Noncrosslinked Acellular Dermal Matrices in a Rabbit Model of Ventral Hernia Repair. [2016]

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

Retention of structural and biochemical integrity in a biological mesh supports tissue remodeling in a primate abdominal wall model. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

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

5. England 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. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of human acellular dermis versus porcine acellular dermis in an in vivo model for incisional hernia repair. [2022]

7. United States 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. [2021]

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

A comparison of human and porcine acellularized dermis: interactions with human fibroblasts in vitro. [2022]

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

The Comparison of Strattice and SurgiMend in Acellular Dermal Matrix-Assisted, Implant-Based Immediate Breast Reconstruction. [2021]