Phasix™ Mesh for Open Laparotomy Recovery
(PREVENT Trial)
Trial Summary
What is the purpose of this trial?
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on medication that might affect wound healing, you may not be eligible to participate.
What data supports the effectiveness of the treatment Phasix™ Mesh for open laparotomy recovery?
Is Phasix™ Mesh generally safe for use in humans?
How is Phasix™ Mesh treatment different from other treatments for open laparotomy recovery?
Phasix™ Mesh is unique because it is a biosynthetic mesh that combines the infection resistance and resorbability of biological meshes with the strength of synthetic meshes. It is designed to be fully absorbed by the body within 12-18 months, reducing the risk of foreign body reactions and infections, especially in contaminated surgical fields.1231112
Research Team
William Hope, MD
Principal Investigator
New Hanover Regional Medical Center
Eligibility Criteria
This trial is for adults who need elective open laparotomy surgery, have a moderate or higher risk of hernia, and can consent to the study. It's not for those with prior mesh implants, contraindications to mesh placement, previous hernia repairs, skin issues at the site, life expectancy under 3 years, pregnancy plans during the trial period, certain steroid use before surgery or known allergies to specific antibiotics.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects undergo open midline laparotomy surgery with either Phasix™ Mesh implantation or primary suture closure
Follow-up
Participants are monitored for incisional hernia and device-related adverse events
Treatment Details
Interventions
- Phasix™ Mesh
Find a Clinic Near You
Who Is Running the Clinical Trial?
C. R. Bard
Lead Sponsor
Timothy M. Ring
C. R. Bard
Chief Executive Officer since 2003
Bachelor of Science in Industrial and Labor Relations from Cornell University
Dr. Cimler
C. R. Bard
Chief Medical Officer since 2017
Ph.D. in Pharmacology