Resorbable Mesh for Ventral Hernia

(RECOVER Trial)

Not currently recruiting at 18 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a special mesh, Transorb™ Self-Gripping Resorbable Mesh, used in surgeries to repair ventral hernias. It focuses on individuals with at least one health issue that might slow wound healing, such as diabetes or a history of smoking. Participants should plan for a specific type of hernia repair surgery that excludes emergency or minimally invasive procedures. The data collected will aid in obtaining market approval and enhancing future treatments. As an unphased trial, this study allows participants to contribute to medical advancements and potentially improve outcomes for others facing similar health challenges.

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 prior data suggests that the Transorb™ self-gripping resorbable mesh is safe for ventral hernia repair?

Research has shown that Transorb™ self-gripping resorbable mesh is generally well-tolerated for ventral hernia repair. Studies indicate that this mesh performs effectively, particularly in surgeries that are clean or only slightly contaminated, meaning it doesn't cause major problems in those situations.

Safety data suggest that the mesh is safe, with tests on sterilized versions yielding good results. While no treatment is completely without risk, past studies have successfully used this mesh, supporting its safety. Prospective participants should discuss any concerns with a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Transorb™ Self-Gripping Resorbable Mesh is unique because it offers a new approach to hernia repair by being absorbable and self-gripping. Most traditional hernia repair meshes are permanent and require sutures, which can lead to complications like chronic pain or infection. This innovative mesh is designed to gradually dissolve in the body, reducing the risk of long-term complications. Researchers are excited about its potential to simplify the surgical process and improve recovery outcomes for patients with ventral hernias.

What evidence suggests that Transorb™ Self-Gripping Resorbable Mesh is effective for ventral hernia repair?

Research shows that the Transorb™ Self-Gripping Resorbable Mesh, which participants in this trial will receive, holds promise for fixing ventral hernias. Surgeons use this mesh to strengthen weak areas in the abdominal wall during surgery. Studies have found that similar self-gripping meshes, such as the ProGrip™, perform well for this purpose. The Transorb™ mesh gradually dissolves over time, reducing the likelihood of needing another surgery for removal. This method aims to improve healing and effectively support the repaired area. Early results suggest it could benefit patients with slower wound healing. ^{1 4 6 7 8}

Who Is on the Research Team?

Bruce Ramshaw, MD, FACS

Principal Investigator

J. Scott Roth, MD, FACS

Principal Investigator

University of Kentucky

Yohann Renard, Prof.

Principal Investigator

CHU de Reims

Frederik Berrevoet, Prof. Dr.

Principal Investigator

University Hospital, Ghent

Matthew Goldblatt, MD, FACS

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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 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]

Citations

1. medtronic.com medtronic.com/content/dam/medtronic-wide/public/united-states/products/hernia-repair/transorb-mesh-product-launch-value-analysis-brief-brochure.pdf

Transorb™ self-gripping resorbable mesh Transorb™ self-gripping resorbable mesh is designed for ventral hernia repair when placed in an extraperitoneal space by open surgical approach.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10635933/

A novel self-gripping long-term resorbable mesh providing ... Such results are in line with clinical studies that have reported the clinical performance of ProGrip™ meshes in ventral hernia repair [33, 34].

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K233661.pdf

February 13, 2024 Sofradim Production Mickaël Nicolas ... Transorb™ Self-Gripping Resorbable Mesh is designed for ventral hernia repair when placed in an extraperitoneal space by open surgical.

4. medtronic.com medtronic.com/en-us/healthcare-professionals/products/hernia-repair/synthetic-mesh/transorb-self-gripping-resorbable-mesh.html

Transorb™ Self-Gripping Resorbable Mesh Transorb™ self-gripping resorbable mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in open procedures ...

5. link.springer.com link.springer.com/article/10.1007/s10856-025-06940-0

Evaluation of a self-gripping slowly resorbable mesh for ... This study evaluates a new self-gripping, slowly resorbable mesh (SRM) for ventral hernia repair, focusing on its in vitro degradation and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12273071/

New synthetic resorbable mesh for open ventral hernia repair Several studies have demonstrated that synthetic resorbable meshes perform well in terms of hernia recurrence in clean-contaminated and ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06449378?cond=hernia&aggFilters=status:not%20rec%20ava&viewType=Table&checkSpell=&rank=4

Transorb™ Self-Gripping Resorbable Mesh in High-risk ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

8. mayo.edu mayo.edu/research/clinical-trials/cls-20575494

Transorb™ Self-Gripping Resorbable Mesh in High-risk ... The purpose of this study is to evaluate the performance and safety of Transorb™ self-gripping resorbable mesh in high-risk subjects (at least ...