477 Participants Needed

Phasix™ Mesh for Open Laparotomy Recovery

(PREVENT Trial)

Recruiting at 29 trial locations
CW
AR
HN
PF
JR
Overseen ByJaime Ritter, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: C. R. Bard
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research shows that Phasix™ Mesh, used in hernia repairs, has low complication rates and improves patients' quality of life over time. It combines the benefits of being absorbable and strong, making it effective in preventing hernia recurrence and reducing infection risks.12345

Is Phasix™ Mesh generally safe for use in humans?

Research on surgical mesh, including similar products, shows that complications can occur, as seen in 380 out of 2874 cases in a study on urogynecologic mesh. This suggests that while many people may not experience issues, there is a risk of adverse events with mesh implants.678910

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

WH

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

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.
I am 18 years old or older.
See 1 more

Exclusion Criteria

Your doctor predicts that you will live less than 3 years.
Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
My surgery needs more than one piece of mesh.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects undergo open midline laparotomy surgery with either Phasix™ Mesh implantation or primary suture closure

Study Day 0
1 visit (in-person)

Follow-up

Participants are monitored for incisional hernia and device-related adverse events

60 months
Regular follow-up visits

Treatment Details

Interventions

  • Phasix™ Mesh
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

C. R. Bard

Lead Sponsor

Trials
109
Recruited
40,200+

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

Findings from Research

Phasix mesh, a fully resorbable implant made from poly-4-hydroxybutyrate, showed significant mechanical strength in a porcine model of abdominal hernia repair, maintaining greater strength compared to the native abdominal wall for up to 48 weeks post-implantation.
Despite a reduction in its molecular weight over time, Phasix mesh effectively transferred load-bearing to the repaired tissue, indicating its capability to support soft tissue reconstruction while gradually resorbing.
Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications.Martin, DP., Badhwar, A., Shah, DV., et al.[2019]
In a multicentre study involving 75 patients over a follow-up period of at least 18 months, Phasix and Phasix ST meshes demonstrated low complication rates, including only 1.3% requiring mesh removal due to infection and an 8.0% recurrence rate.
Patients reported significant improvements in quality of life, with utility values increasing from 0.768 at baseline to 0.967 at 36 months, indicating that these biosynthetic meshes are effective not only in preventing hernia recurrence but also in enhancing overall patient well-being.
Clinical outcomes and quality of life associated with the use of a biosynthetic mesh for complex ventral hernia repair: analysis of the "Italian Hernia Club" registry.Rognoni, C., Cuccurullo, D., Borsoi, L., et al.[2021]
Phasix™ Mesh, a biosynthetic mesh, is being evaluated for its safety and performance in treating VHWG Grade 3 hernia patients, with a total of 85 participants across 15 sites in Europe.
The primary focus of the study is to assess Surgical Site Occurrence (SSO) within 3 months post-surgery, with secondary outcomes including recurrence and quality of life assessed over 24 months, potentially positioning Phasix™ Mesh as a preferred option for hernia repair in contaminated fields.
A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair: a research protocol.van Rooijen, MMJ., Jairam, AP., Tollens, T., et al.[2019]

References

Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. [2019]
Clinical outcomes and quality of life associated with the use of a biosynthetic mesh for complex ventral hernia repair: analysis of the "Italian Hernia Club" registry. [2021]
A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair: a research protocol. [2019]
Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up. [2023]
Safety and Efficacy of Crura Augmentation with Phasix ST Mesh for Large Hiatal Hernia: 3-Year Single-Center Experience. [2020]
[Surgical adverse events in three Mexican public health institutions]. [2012]
Early outcomes of an enhanced recovery protocol for open repair of ventral hernia. [2019]
Harnessing a health information exchange to identify surgical device adverse events for urogynecologic mesh. [2021]
Enhanced value with implementation of an ERAS protocol for ventral hernia repair. [2021]
10.Korea (South)pubmed.ncbi.nlm.nih.gov
An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Mechanical and Histological Characteristics of Phasix™ ST Mesh in a Porcine Model of Hernia Repair. [2022]
What results can be expected one year after complex incisional hernia repair with biosynthetic mesh? [2021]