Phasix™ Mesh for Open Laparotomy Recovery

(PREVENT Trial)

Recruiting at 32 trial locations

Overseen By Jaime Ritter, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: C. R. Bard

Disqualifiers: Previous hernia repair, Emergent surgery, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Study Day 0

477 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for closing the abdomen after major surgery in the belly area. Researchers aim to determine if using a special mesh called Phasix™ Mesh can prevent hernias (a bulge or lump that can occur after surgery) more effectively than stitching the area closed. Participants who have undergone open midline laparotomy (a large surgical cut along the middle of the belly) and are at moderate or higher risk for a hernia might be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative surgical techniques that could enhance recovery outcomes for future patients.

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 prior data suggests that Phasix™ Mesh is safe for open laparotomy recovery?

Research has shown that Phasix™ Mesh is generally safe and well-tolerated. In one study, patients using this mesh did not experience any long-term problems. The chance of hernia recurrence was low, with only 15.9% of cases experiencing a recurrence over five years. Another study found no infections related to the mesh and only a few other issues. These results suggest that the mesh is safe for individuals needing hernia repair. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Phasix™ Mesh for open laparotomy recovery because it offers a novel approach to preventing complications like hernias after surgery. Unlike traditional methods, which rely solely on primary suture closure, Phasix™ Mesh involves a prophylactic onlay placement of a bioresorbable mesh. This mesh is designed to reinforce the surgical site, providing added support and potentially reducing the risk of hernia formation over time. Its bioresorbable nature means it gradually dissolves in the body, minimizing long-term foreign material presence and potentially improving patient outcomes.

What evidence suggests that Phasix™ Mesh is effective for preventing incisional hernia?

Research has shown that Phasix™ Mesh might help prevent hernias after surgery. One study found that only 15.9% of patients experienced hernia recurrence over five years, with no long-term issues from the mesh. Another study reported a 10.3% hernia recurrence rate after one year in patients with complex hernia repairs using the mesh. In this trial, participants will either receive the Phasix™ Mesh or undergo primary suture closure. These findings suggest that Phasix™ Mesh could reduce the risk of hernia recurrence, with few complications. ^{2 3 6 7 8}

Who Is on the Research Team?

William Hope, MD

Principal Investigator

New Hanover Regional Medical Center

Are You a Good Fit for This Trial?

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.

You are capable and have consented to provide written permission.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Phasix™ Mesh

Trial Overview

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.

How Is the Trial Designed?

Group I: Phasix™ Mesh Experimental Treatment 1 Intervention

Prophylactic onlay placement of mesh.

Group II: Primary Suture Closure Active Control 1 Intervention

Standard Fascial closure.

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

Published Research Related to This Trial

In a study involving 121 patients, the use of poly-4-hydroxybutyrate (P4HB) mesh for hernia repair showed a low recurrence rate of 17.9% after 3 years, indicating its effectiveness in long-term outcomes.

The study reported a low incidence of surgical site infections (9.3%) and no late complications or need for mesh removal, suggesting that P4HB mesh is a safe option for patients at risk for complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, multicenter study of P4HB (Phasix™) mesh for hernia repair in cohort at risk for complications: 3-Year follow-up. Roth, JS., Anthone, GJ., Selzer, DJ., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 29 patients who underwent ventral hernia repair with Phasix® biosynthetic mesh, the 1-year recurrence rate was found to be 10.3%, indicating a moderate level of effectiveness for this type of mesh in preventing hernia recurrence.

The study reported no severe complications or chronic infections related to the mesh, suggesting that Phasix® is a safe option for hernia repair, especially in contaminated fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What results can be expected one year after complex incisional hernia repair with biosynthetic mesh? Vauclair, E., Bert, M., Facy, O., et al.[2021]

In a study of 73 patients undergoing laparoscopic repair of large hiatal hernias with Phasix ST absorbable mesh, the recurrence rate of hernias was low at 3.2%, with no patients requiring reoperation, indicating the safety and effectiveness of this approach.

Patients reported significant improvements in quality of life post-surgery, as measured by both the SF-36 and GERD-HRQL questionnaires, demonstrating the positive impact of the procedure on their health and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Crura Augmentation with Phasix ST Mesh for Large Hiatal Hernia: 3-Year Single-Center Experience. Panici Tonucci, T., Asti, E., Sironi, A., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. Martin, DP., Badhwar, A., Shah, DV., et al.[2019]

An automated search algorithm was developed to effectively identify complications related to urogynecologic mesh surgeries, matching 93% of cases found through manual review of 2874 records.

This method successfully identified complications in 380 of the cases, demonstrating that automated surveillance can enhance the tracking of device-related adverse events in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing a health information exchange to identify surgical device adverse events for urogynecologic mesh. Ballard, J., Rosenman, M., Weiner, M.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 24 Yucatan pigs, Phasix™ ST Mesh demonstrated consistent mechanical strength and histological properties across different defect sizes (4 cm and 8 cm) for up to 72 weeks post-implantation, indicating its reliability for hernia repair.

The histological analysis revealed mature collagen and fibrovascular tissue formation around the mesh, suggesting effective tissue integration, although the molecular weight of the mesh decreased over time, which may impact its long-term performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical and Histological Characteristics of Phasix™ ST Mesh in a Porcine Model of Hernia Repair. Deeken, CR., Gagne, DH., Badhwar, A.[2022]

The study found that the prevalence of adverse events (AEs) in surgical adult patients in Mexico was 4.1%, indicating a notable concern for patient safety in surgical settings.

Patients aged 65 and older treated in larger hospitals were at a higher risk for experiencing AEs, and those who did experience an AE had an average hospital stay that was nine days longer than those without AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical adverse events in three Mexican public health institutions]. Pineda-Pérez, D., Puentes-Rosas, E., Rangel-Chávez, NJ., et al.[2012]

The implementation of an Enhanced Recovery After Surgery (ERAS) protocol for open ventral hernia repair (VHR) in 46 patients led to a significantly earlier return of bowel function (3 days vs. 4 days) compared to 125 historical controls.

Patients under the ERAS protocol also experienced a lower rate of superficial surgical site infections (7% vs. 25%), indicating improved safety and efficacy of the surgical recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early outcomes of an enhanced recovery protocol for open repair of ventral hernia. Stearns, E., Plymale, MA., Davenport, DL., et al.[2019]

The implementation of an Enhanced Recovery after Surgery (ERAS) protocol for open ventral hernia repair (VHR) led to faster recovery of bowel function and a lower rate of superficial surgical site infections in 51 patients compared to 127 patients treated before the protocol was in place.

Despite increased inpatient pharmacy costs for the ERAS group, the overall hospital costs remained similar between the ERAS and pre-ERAS groups, indicating that the ERAS protocol improves clinical outcomes without raising total healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced value with implementation of an ERAS protocol for ventral hernia repair. Harryman, C., Plymale, MA., Stearns, E., et al.[2021]

The MAUDE database has significant limitations in capturing and standardizing adverse events related to transvaginal mesh, with issues like missing and duplicated reports affecting data quality.

Nearly half of the reports did not identify a source, and at least 28% of the devices reported are no longer available on the market, highlighting the need for improved reporting systems to better assess device safety.

NCBI (Pubmed)

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. Sandberg, JM., Gray, I., Pearlman, A., et al.[2019]

Citations

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pmc.ncbi.nlm.nih.gov

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Results show a low recurrence rate of 15.9%, 4 recurrences between 2 and 5 years, and no long-term mesh complications, making the Phasix mesh a ...

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nature.com

nature.com/articles/s41598-020-67821-w

analysis of the “Italian Hernia Club” registry

Phasix meshes have proven to be suitable prostheses in preventing recurrence, with promising outcomes in terms of early and late complications and in improving ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1878788620302149

What results can be expected one year after complex ...

Patients having undergone complex ventral hernia repair with a Phasix® mesh have a 1-year recurrence rate of 10.3%. No severe surgical site occurrence was ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8182350/

Outcomes of mid-term and long-term degradable ...

Mesh removal for persistent local infection occurred in 10% (7 of 70) after a median of 229 days since surgery. Salvage rate of mesh after ...

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journals.lww.com

journals.lww.com/journalacs/fulltext/2022/12000/long_term,_prospective,_multicenter_study_of.11.aspx

Long-term, prospective, multicenter study of poly-4- ...

Five-year outcomes after VIHR with P4HB mesh were associated with infrequent complications and durable hernia repair outcomes. This study provides a framework ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6247668/

A post-market, prospective, multi-center, single-arm clinical ...

A total of 85 VHWG Grade 3 hernia patients will be treated with Phasix™ Mesh in 15 sites across Europe. The primary outcome is Surgical Site ...

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wsusurgery.com

wsusurgery.com/wp-content/uploads/2023/07/Lee-Mesh-v2.pdf

Mesh v2 - Detroit - Wayne State University

open and laparoscopic procedures to just open primary repair. The outcomes studied were five- year risk of reoperation and mesh complications.

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health.ec.europa.eu

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Expert decision and opinion in the context of the Clinical ...

Results showed a 20% incisional hernia rate at a median follow-up of 2.2 years, with no mesh infections and low rates of other complications, ...