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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year postoperatively
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
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.
Select...
I am considered fit for surgery and do not have severe heart, lung, kidney, or blood diseases.
Select...
I need a special mesh for closing a large abdominal tumor surgery wound.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall complication rate at 1 year
Secondary outcome measures
Bulge rate at 1 year
Bulge rate at 30 days
Hernia recurrence rate at 1 year
+12 more

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

Find a Location

Who is running the clinical trial?

Jeffrey E Janis, MDLead Sponsor
Jeffrey JanisLead Sponsor

Media Library

Strattice (Acellular Dermal Matrix) Clinical Trial Eligibility Overview. Trial Name: NCT02228889 — N/A
Ventral Hernia Research Study Groups: XenMatrix, Strattice
Ventral Hernia Clinical Trial 2023: Strattice Highlights & Side Effects. Trial Name: NCT02228889 — N/A
Strattice (Acellular Dermal Matrix) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02228889 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved an assessment of potential issues 30 days after a procedure?

"Assessing the overall complications at 30 days postoperatively is thought to be a safe procedure, and has thus been given a rating of 3. This treatment holds an approval status due to it being tested during Phase 4 clinical trials."

Answered by AI

Is this clinical trial open to individuals under the age of fifty?

"This trial is open only to individuals between 18 and 99 years old. There are an additional 32 studies specifically targeting younger patients, while 242 trials are focused on seniors over 65."

Answered by AI

How many individuals have enrolled in the trial thus far?

"Affirmative. According to the details on clinicaltrials.gov, this medical study is actively enrolling participants. The trial was initially listed on January 1st 2015 and recently updated on September 21st 2022; it aims to recruit 70 individuals from a single site."

Answered by AI

Is it possible for me to enlist in this research program?

"Qualifying for this study requires that participants have a hernia, ventral and must fall within 18 to 99 years of age. This medical trial is presently accepting 70 enrollees in total."

Answered by AI

Is enrollment currently ongoing for this experiment?

"Correct. Clinicaltrials.gov affirms that this research endeavour, which commenced on the first of January 2015, is seeking participants. 70 individuals must be enrolled at 1 trial site to complete the study."

Answered by AI

Who else is applying?

What state do they live in?
Idaho
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
Jeffrey Janis 2015. "RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02228889.
All > Paid Studies Ohio > Hernia
~10 spots leftby Dec 2025
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