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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 up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
I am an adult scheduled for abdominal wall reconstruction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
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.
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
810 Previous Clinical Trials
886,204 Total Patients Enrolled
MedtronicIndustry Sponsor
619 Previous Clinical Trials
763,998 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Two surgeons agree I need a biologic implant.I am an adult scheduled for abdominal wall reconstruction.
Research Study Groups:
This trial has the following groups:- Group 1: Strattice biologic mesh
- Group 2: Permacol biologic mesh
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.