Resorbable Mesh for Ventral Hernia

(RECOVER Trial)

Recruiting at 11 trial locations

Overseen By Study Mailbox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic - MITG

Must not be taking: Anticoagulants, Immunosuppressants, Chemotherapy

Disqualifiers: HIV, Dialysis, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

163 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of RECOVER is to evaluate the performance and safety of Transorb™ self-gripping resorbable mesh in high-risk subjects (at least one risk factor impairing wound healing) when used for reinforcement of abdominal wall soft tissues in procedures involving open extraperitoneal ventral hernia repair, in clean (US); and clean and clean-contaminated (Europe) surgical fields (Centers for Disease Control and Prevention (CDC) Classification I and II. Data from this study will primarily be used to support market approval and European post-market clinical follow-up needs. Secondarily, data will be used for product marketing, future product development, and to support market release and maintenance in global geographies.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulants (blood thinners), you may need to stop them before surgery based on your surgeon's advice, except for aspirin.

What makes Transorb Self-Gripping Resorbable Mesh unique for ventral hernia treatment?

Transorb Self-Gripping Resorbable Mesh is unique because it is a self-gripping, long-term resorbable mesh that provides temporary support during ventral hernia repair. It is made from a special copolymer that maintains mechanical strength for at least 20 weeks, allowing it to support the healing process effectively. The mesh's grips help anchor it securely in place, promoting integration with the body's tissues. ^{1 2 3 4 5}

Research Team

Matthew Goldblatt, MD, FACS

Principal Investigator

Medical College of Wisconsin

Bruce Ramshaw, MD, FACS

Principal Investigator

J. Scott Roth, MD, FACS

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for adults over 18 with a high risk of complications in wound healing, undergoing elective open repair of ventral hernia. Eligible participants include current or former heavy smokers, those with obesity (BMI between 30 and 39.9), and individuals with COPD. The surgery must involve retrorectus/retromuscular mesh placement, possibly including TAR.

Inclusion Criteria

My BMI is between 30 and 39.9, indicating obesity.

My surgery involved the gastrointestinal tract with little to no leakage.

I have signed the consent form for the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo open ventral hernia repair with Transorb™ mesh and initial recovery

1 month

Inpatient stay until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hernia recurrence and surgical site occurrences

60 months

Regular follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months

Treatment Details

Interventions

• Transorb™ Self-Gripping Resorbable Mesh

Trial Overview The RECOVER study tests the performance and safety of Transorb™ Self-Gripping Resorbable Mesh in reinforcing abdominal wall tissues during ventral hernia repair surgeries that are clean or clean-contaminated as per CDC guidelines.

Participant Groups

Group I: Hernia Repair Experimental Treatment 1 Intervention

single arm study, no control arm

Transorb™ Self-Gripping Resorbable Mesh is already approved in United States, European Union for the following indications:

Approved in United States as Transorb Self-Gripping Resorbable Mesh for:

• Reinforcement of abdominal wall soft tissues where weakness exists in open procedures involving ventral hernia repair

Approved in European Union as Transorb Self-Gripping Resorbable Mesh for:

• Reinforcement of abdominal wall soft tissues where weakness exists in open procedures involving ventral hernia repair

Who Is Running the Clinical Trial?

Medtronic - MITG

Lead Sponsor

Trials

265

Recruited

301,000+

Geoff Martha

Medtronic - MITG

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. John Doe

Medtronic - MITG

Chief Medical Officer since 2023

MD from Harvard Medical School

Findings from Research

The newly developed self-gripping resorbable mesh for ventral hernia repair demonstrated strong mechanical support for at least 20 weeks, which is crucial for the healing process, as shown in in-vitro tests and a preclinical porcine model.

In vivo studies indicated that the mesh was well tolerated, integrated quickly into the abdominal wall, and provided higher burst strength at 4 and 12 weeks compared to native tissue, suggesting its effectiveness for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel self-gripping long-term resorbable mesh providing temporary support for open primary ventral and incisional hernia. Vestberg, R., Lecuivre, J., Radlovic, A., et al.[2023]

In a study of 121 high-risk patients undergoing complex ventral and incisional hernia repair with poly-4-hydroxybutyrate (P4HB) resorbable mesh, the procedure showed positive outcomes with a low incidence of hernia recurrence (9%) at 18 months post-surgery.

The study included patients with significant comorbidities, such as obesity and diabetes, indicating that P4HB mesh is a promising option for high-risk individuals, supporting strength restoration of the abdominal wall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up. Roth, JS., Anthone, GJ., Selzer, DJ., et al.[2019]

In a study of 121 comorbid patients undergoing ventral and incisional hernia repair with poly-4-hydroxybutyrate mesh (P4HB), the 5-year follow-up showed a hernia recurrence rate of 22% and a surgical site infection rate of 10%, indicating relatively low long-term complications.

The use of P4HB mesh resulted in significant improvements in pain and quality of life over 60 months, with a notable reduction in pain scores and a positive change in comfort levels, suggesting its efficacy in hernia repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up. Roth, JS., Anthone, GJ., Selzer, DJ., et al.[2022]

In a study of 88 patients undergoing laparoscopic ventral hernia repair, the new lightweight mesh with a bioresorbable coating (Physiomesh) significantly reduced postoperative pain and allowed for an early return to work.

Physiomesh showed acceptable complication rates and low recurrence and reintervention rates, making it a promising alternative to traditional meshes for hernia repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective study on the use of a composite mesh (Physiomesh) in laparoscopic ventral hernia repair. Tollens, T., Maxime, E., Anthony, B., et al.[2013]

In a study of 83 patients with incisional hernia, the use of ProGrip self-gripping mesh significantly reduced operative time and hospital stays compared to conventional polypropylene mesh, indicating improved efficiency in surgical repair.

Postoperative pain, measured by the visual analogue scale (VAS), was lower in the self-gripping mesh group at multiple time points, suggesting that ProGrip mesh may enhance patient comfort without increasing the risk of complications like chronic pain or hernia recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy comparison between ProGrip self-gripping mesh and polypropylene mesh for retromuscular repair of incisional hernias]. Sun, P., Fei, Y., Wang, S., et al.[2021]

References

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

A novel self-gripping long-term resorbable mesh providing temporary support for open primary ventral and incisional hernia. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up. [2019]

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

Long-Term, Prospective, Multicenter Study of Poly-4-Hydroxybutyrate Mesh (Phasix Mesh) for Hernia Repair in Cohort at Risk for Complication: 60-Month Follow-Up. [2022]

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

Retrospective study on the use of a composite mesh (Physiomesh) in laparoscopic ventral hernia repair. [2013]

5. China pubmed.ncbi.nlm.nih.gov

[Efficacy comparison between ProGrip self-gripping mesh and polypropylene mesh for retromuscular repair of incisional hernias]. [2021]