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Biosynthetic Mesh
Phasix Mesh Use in Complex Open Ventral Hernias Study
N/A
Waitlist Available
Led By Julie Holihan, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new type of mesh made from synthetic material to repair complex ventral hernias. It aims to see if this new mesh works better than current options like synthetic polypropylene mesh or sutures. The mesh helps by supporting the abdominal wall, allowing it to heal and reducing the risk of the hernia coming back. Hybrid mesh products have been designed to address the need for a cost-effective mesh leveraging the tensile strength of a synthetic mesh while minimizing the prosthetic footprint within the abdominal wall through resorbable materials.
Eligible Conditions
- Ventral Hernia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Major complication free
Secondary study objectives
Clavien-Dindo complication grade
Cost Analysis
Emergency room visits
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Phasix MeshActive Control1 Intervention
Phasix mesh will be used in the repair of the hernia
Group II: Current CareActive Control1 Intervention
The hernia will be repaired with either synthetic mesh or suture repair, as determined by the operating surgeon.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,857 Total Patients Enrolled
Julie Holihan, MDPrincipal InvestigatorUTHealth
2 Previous Clinical Trials
663 Total Patients Enrolled