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Biologic Mesh

Biologic Meshes for Ventral Hernia

Phase 2 & 3

Recruiting

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

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

Must have

Adult patients, 18 years or older, undergoing an abdominal wall reconstruction

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months postoperation

Awards & highlights

Study Summary

This trial will compare the two most popular types of biologic mesh to see which is better.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed, potential risks may include infection, rejection or failure of the mesh, allergic reactions, pain at the surgical site, and complications related to surgery.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am an adult scheduled for abdominal wall reconstruction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months postoperation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months postoperation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months postoperation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The percentage of hernia recurrence in patients received the biologic meshes.

Secondary outcome measures

The days of hospital stay post the abdominal wall reconstruction procedure.

The percentage of wound infection of the participants.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Permacol biologic meshExperimental Treatment1 Intervention

Permacol mesh is made of cross-linked porcine dermis, which is used to support abdominal wall reconstruction.

Group II: Strattice biologic meshActive Control1 Intervention

Strattice mesh is made of noncross-linked porcine dermis, which is used to support abdominal wall reconstruction.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

791 Previous Clinical Trials

868,644 Total Patients Enrolled

MedtronicIndustry Sponsor

606 Previous Clinical Trials

828,575 Total Patients Enrolled

Media Library

Permacol biologic mesh (Biologic Mesh) Clinical Trial Eligibility Overview. Trial Name: NCT02703662 — Phase 2 & 3

Ventral Hernia Research Study Groups: Strattice biologic mesh, Permacol biologic mesh

Ventral Hernia Clinical Trial 2023: Permacol biologic mesh Highlights & Side Effects. Trial Name: NCT02703662 — Phase 2 & 3

Permacol biologic mesh (Biologic Mesh) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02703662 — Phase 2 & 3

Frequently Asked Questions

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

Could you please share how many people are included in this research project?

"That is accurate, the clinical trial indicated on clinicaltrials.gov is currently looking for participants. The original posting was on October 26th, 2017 with the most recent update being March 11th, 2021. They are 90 spots open at a single site."

Answered by AI

Are volunteers currently being enrolled in this research study?

"That is correct. The clinicaltrials.gov website shows that this research is looking for more participants and was last updated on March 11th, 2021. This trial began enrolling patients on October 26th, 2017 and needs a total of 90 individuals from 1 site."

Answered by AI

Recent research and studies

SurgeryJournal

Routine Use of Bioprosthetic Mesh Is Not Necessary: A Retrospective Review of 100 Consecutive Cases of Intra-abdominal Midweight Polypropylene Mesh for Ventral Hernia Repair

Richmond, Bryan K., and Benny Chong. 2013. “Routine Use of Bioprosthetic Mesh Is Not Necessary: A Retrospective Review of 100 Consecutive Cases of Intra-abdominal Midweight Polypropylene Mesh for Ventral Hernia Repair”. Surgery. Elsevier BV. doi:10.1016/j.surg.2013.02.006.

Annals of SurgeryJournal

A 5-year Clinical Experience with Single-staged Repairs of Infected and Contaminated Abdominal Wall Defects Utilizing Biologic Mesh

Rosen, Michael J., David M. Krpata, Bridget Ermlich, and Jeffrey A. Blatnik. 2013. “A 5-year Clinical Experience with Single-staged Repairs of Infected and Contaminated Abdominal Wall Defects Utilizing Biologic Mesh”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0b013e3182849871.

The American Journal of SurgeryJournal

Single Institutional Experience Using Biological Mesh for Abdominal Wall Reconstruction

Iacco, Anthony, Adewunmi Adeyemo, Thomas Riggs, and Randy Janczyk. 2014. “Single Institutional Experience Using Biological Mesh for Abdominal Wall Reconstruction”. The American Journal of Surgery. Elsevier BV. doi:10.1016/j.amjsurg.2013.09.020.

International Journal of SurgeryJournal