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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60-months
Awards & highlights

PREVENT Trial 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.Check my eligibility
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.See study design
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.

PREVENT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a major abdominal surgery through a cut of at least 5 cm.
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.
Select...
I am scheduled for or have had a major abdominal surgery through a cut that is at least 5 cm long.

PREVENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Length of hospital stay in days
Length of surgical procedure in minutes
Length of time for wound closure in minutes
+4 more

PREVENT Trial 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
38,988 Total Patients Enrolled
William Hope, MDPrincipal InvestigatorNew Hanover Regional Medical Center
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Phasix™ Mesh (Mesh Implant) Clinical Trial Eligibility Overview. Trial Name: NCT03911700 — N/A
Open Laparotomy Research Study Groups: Primary Suture Closure, Phasix™ Mesh
Open Laparotomy Clinical Trial 2023: Phasix™ Mesh Highlights & Side Effects. Trial Name: NCT03911700 — N/A
Phasix™ Mesh (Mesh Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03911700 — N/A
Open Laparotomy Patient Testimony for trial: Trial Name: NCT03911700 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
California
Illinois
What site did they apply to?
University of California San Francisco
OSF Saint Francis Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Looking for ways to be as healthy as possible. I have had multiple abdominal surgeries in my lifetime and know that my abdominal muscles are seriously lacking.
PatientReceived 2+ prior treatments
~267 spots leftby Sep 2029