Phasix™ Mesh for Open Laparotomy Recovery

(PREVENT Trial)

Recruiting at 29 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

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 11 12}

Research Team

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.

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

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 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.

Participant Groups

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

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.

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Characterization of poly-4-hydroxybutyrate mesh for hernia repair applications. [2019]

2. England 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. [2021]

3. England 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. [2019]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Crura Augmentation with Phasix ST Mesh for Large Hiatal Hernia: 3-Year Single-Center Experience. [2020]

6. Mexico pubmed.ncbi.nlm.nih.gov

[Surgical adverse events in three Mexican public health institutions]. [2012]

7. Germany pubmed.ncbi.nlm.nih.gov

Early outcomes of an enhanced recovery protocol for open repair of ventral hernia. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Harnessing a health information exchange to identify surgical device adverse events for urogynecologic mesh. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Mechanical and Histological Characteristics of Phasix™ ST Mesh in a Porcine Model of Hernia Repair. [2022]

12. France pubmed.ncbi.nlm.nih.gov

What results can be expected one year after complex incisional hernia repair with biosynthetic mesh? [2021]