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Phasix™ Mesh for Open Laparotomy Recovery (PREVENT Trial)
PREVENT Trial Summary
This trial is to see if the Phasix Mesh implant prevents incisional hernias better than just using regular stitches.
PREVENT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPREVENT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PREVENT Trial Design
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Who is running the clinical trial?
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- Your doctor predicts that you will live less than 3 years.You have a moderate or high risk of developing a hernia.I am scheduled for a major abdominal surgery through a cut of at least 5 cm.My surgery needs more than one piece of mesh.I have had surgery with two separate cuts.You cannot have a mesh implanted due to a medical condition.I have had surgery to fix a hernia before.I am 18 years old or older.I have a current skin condition.I am 18 years old or older.You have had a mesh surgically implanted in the past.I do not have an active severe infection.You have a high risk of developing a hernia.You are capable and have consented to provide written permission.I am allergic to tetracycline or kanamycin.I have taken corticosteroids like prednisone before surgery.I am scheduled for a second surgery.My surgeon could not completely close the inner layer of my abdomen.I need surgery urgently.I am scheduled for or have had a major abdominal surgery through a cut that is at least 5 cm long.My surgery will involve creating skin flaps.I am part of the staff working on this clinical trial.
- Group 1: Primary Suture Closure
- Group 2: Phasix™ Mesh
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are additional volunteers sought for this trial?
"Affirmative. Clinicaltrials.gov indicates that the recruitment for this trial is ongoing, with registration starting on December 12th 2019 and being updated as recently as October 24th 2022. 477 participants are required from 17 sites around the nation."
What is the current enrollment rate for participants in this research project?
"This medical trial necessitates 477 participants who qualify for the set inclusion criteria to join. Potential candidates can locate participating sites in both Peoria, Illinois (OSF Saint Francis Medical Center) and Omaha, Nebraska (Nebraska Medical Centre)."
How many facilities are presently conducting this research trial?
"Presently, 17 sites are running the clinical trial. These locations span from Peoria to Omaha and Bronx as well as 14 other locales. It is prudent for participants to select a site that minimizes their travel burden if they decide to enroll."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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