The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject must be diagnosed with incisional midline hernia.
* Subject has a VHWG Grade 3 hernia (as defined in the protocol).
* Size of hernia ≥ 10 cm2.
* Subject must be willing to undergo a planned retro-rectus hernia repair (onlay allowed as an exception when retro-rectus placement cannot be achieved; using absorbable suture) with or without Component Separation Technique.
Exclusion Criteria:
* Subject with \> 4 previous repairs of the hernia under observation.
* Body Mass Index (BMI) \> 35 kg/m2.
* The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study.
* The subject has peritonitis.
* Known human immunodeficiency virus (HIV) infection (if documented in the subject's record).
* The subject has cirrhosis of the liver and/or ascites.
* Subject is American Society of Anesthesiology Class 4 or 5.
* Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
* The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides).
* Subject has intact permanent mesh adjacent to the current hernia to be repaired.
* Subject's hernia repair requires intraabdominal mesh placement.
* Surgical technique requires surgical bridge repair as the sole repair.
* Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the fol…
What they're measuring
1
Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure