Your session is about to expire
← Back to Search
Mesh Implant
Phasix™ Mesh for Open Laparotomy Recovery (PREVENT Trial)
N/A
Recruiting
Led By William Hope, MD
Research Sponsored by C. R. Bard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Elective, open midline laparotomy ≥ 5 cm
Must be ≥ 18 years of age
Must not have
The surgery requires more than a single piece of mesh
Two separate incisions are created
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60-months
Awards & highlights
Summary
This trial is to see if the Phasix Mesh implant prevents incisional hernias better than just using regular stitches.
Who is the study for?
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.
What is being tested?
The study tests if implanting Phasix™ Mesh during midline fascial closure in abdominal surgery is better than just suturing for preventing future incisional hernias in patients with a high risk of this complication.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, infection risks associated with surgical mesh implants and possible allergic reactions to materials within Phasix™ Mesh.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a major abdominal surgery through a cut of at least 5 cm.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My surgery needs more than one piece of mesh.
Select...
I have had surgery with two separate cuts.
Select...
I have had surgery to fix a hernia before.
Select...
I have a current skin condition.
Select...
I do not have an active severe infection.
Select...
I am allergic to tetracycline or kanamycin.
Select...
I am scheduled for a second surgery.
Select...
My surgeon could not completely close the inner layer of my abdomen.
Select...
I need surgery urgently.
Select...
My surgery will involve creating skin flaps.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incisional hernia
Secondary outcome measures
Length of hospital stay in days
Length of surgical procedure in minutes
Length of time for wound closure in minutes
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Phasix™ MeshExperimental Treatment1 Intervention
Prophylactic onlay placement of mesh.
Group II: Primary Suture ClosureActive Control1 Intervention
Standard Fascial closure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phasix™ Mesh
2016
N/A
~90
Find a Location
Who is running the clinical trial?
C. R. BardLead Sponsor
103 Previous Clinical Trials
39,123 Total Patients Enrolled
William Hope, MDPrincipal InvestigatorNew Hanover Regional Medical Center
1 Previous Clinical Trials
120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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 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 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.My surgery will involve creating skin flaps.I am part of the staff working on this clinical trial.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Suture Closure
- Group 2: Phasix™ Mesh
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Open Laparotomy Patient Testimony for trial: Trial Name: NCT03911700 — N/A
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger