Comparing outcomes of two types of surgical mesh for ventral hernia repair
A Comparison of the Outcomes in Fortiva and Strattice Mesh
This study is testing which type of surgical mesh, Fortiva or Strattice, works better for repairing ventral hernias by looking at how often hernias come back and any complications that arise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT05572021 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of two types of biologic mesh, Fortiva and Strattice, in repairing ventral hernias. It is a prospective, matched study where patients receiving Fortiva mesh will be compared to a retrospective cohort of patients who had Strattice mesh. The primary focus is on determining the rates of hernia recurrence and complications associated with each type of mesh. Patients will be matched based on age, sex, and hernia defect size to ensure a fair comparison.
Who should consider this trial
Good fit: Ideal candidates are individuals with a ventral hernia requiring surgical repair who meet the inclusion criteria.
Not a fit: Patients who are pregnant will not benefit from this study due to exclusion criteria.
Why it matters
Potential benefit: If successful, this study could help identify the more effective mesh option for ventral hernia repair, potentially reducing recurrence rates and complications for patients.
How similar studies have performed: Other studies have explored the use of different biologic meshes in hernia repair, but this specific comparison of Fortiva and Strattice is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ventral Hernia requiring surgical repair Exclusion Criteria: * Pregnant women
Where this trial is running
Charlotte, North Carolina
- Carolinas Medical Center — Charlotte, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Todd Heniford, MD — Wake Forest University Health Sciences
- Study coordinator: Gregory T Scarola, MS
- Email: Gregory.Scarola@Atriumhealth.org
- Phone: 704-355-5379
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.