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Acellular Dermal Matrix

Porcine Acellular Dermal Matrices for Hernia Repair

N/A

Recruiting

Research Sponsored by Jeffrey E Janis, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18

Patients presenting for elective hernia repair, with Ventral Hernia Working Group (VHWG) grade 2 or above and who have comorbidities or contamination making the use of synthetic mesh contraindicated

Must not have

Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective hernia repair

Patients presenting for emergent hernia repair

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two types of pig-skin derived, sterilized meshes commonly used for hernia repair and abdominal wall reconstruction.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include pain at the surgery site, bulging of the repaired area, complications like infections at the surgical site within a month or year post-surgery, and possible allergic reactions to porcine products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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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.

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

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I need a special mesh for closing a large abdominal tumor surgery wound.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am here for an urgent hernia repair.

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I do not have a severe infection throughout my body.

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My wound is oozing pus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall complication rate at 1 year

Secondary study objectives

Overall complication rate at 30 days

Pain intensity postoperatively

Pain intensity preoperatively

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: XenMatrixExperimental Treatment18 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: StratticeExperimental Treatment18 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Strattice

2016

Completed Phase 4

~360

0 / 8Eligibility criteria met