Comparing two types of biologic mesh for abdominal wall reconstruction
Performance of Biologic Mesh Materials in Abdominal Wall Reconstruction - A Randomized Controlled Trial
PHASE2; PHASE3 · University of Calgary · NCT02703662
This study is testing which of two types of biologic mesh, Strattice or Permacol, works better for people having surgery to fix ventral hernias and reduce the chance of them coming back.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Calgary (other) |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT02703662 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the performance of two popular biologic mesh materials, Strattice and Permacol, in patients undergoing abdominal wall reconstruction for ventral hernias. It is a randomized controlled trial that will assess the effectiveness of these meshes in reducing hernia recurrence, particularly in cases with complications such as infection or contamination. The study will involve adult patients who require surgical intervention and will be conducted at the Foothills Medical Centre in Calgary, Alberta. The trial seeks to provide valuable data on the clinical outcomes associated with each type of biologic mesh.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 years or older who require abdominal wall reconstruction.
Not a fit: Patients who are unable or unwilling to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and lower recurrence rates for patients undergoing abdominal wall reconstruction.
How similar studies have performed: While there have been studies on biologic meshes, this trial is novel as it specifically compares two leading products in a randomized controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The study population will consist of adult patients, 18 years or older, undergoing an abdominal wall reconstruction. Prior to selection, at least 2 surgeons involved in the trial must agree that the indication for use of biologic implant is mutual. Exclusion Criteria: * Patients will be excluded if they are unable or unwilling to provide informed consent.
Where this trial is running
Calgary, Alberta
- Foothills Medical Centre, Faculty of Medicine — Calgary, Alberta, Canada (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ventral Hernia, Biologic mesh, abdominal wall reconstruction