Resorbable Mesh for Ventral Hernia
(RECOVER Trial)
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medtronic - MITG
Must not be taking: Anticoagulants, Immunosuppressants, Chemotherapy
Disqualifiers: HIV, Dialysis, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Eligibility 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.
+7 more
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Hernia RepairExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo ClinicRochester, MN
Novant Health New Hanover Regional Medical CenterWilmington, NC
TPMG General Surgery and Hernia CenterNewport News, VA
Endeavor HealthEvanston, IL
More Trial Locations
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Who Is Running the Clinical Trial?
Medtronic - MITGLead Sponsor
References
A novel self-gripping long-term resorbable mesh providing temporary support for open primary ventral and incisional hernia. [2023]A novel synthetic fully long-term resorbable self-gripping mesh has been recently developed to reinforce soft tissue where weakness exists during ventral hernia repair open procedures. This resorbable mesh is a macroporous, knitted, poly-L-lactide, poly-trimethylene carbonate copolymer monofilament mesh with the ProGrip™ technology, providing grips on one side of the mesh. A new poly-L-lactide, poly-trimethylene copolymer was developed to provide the required features for mechanical support during at least 20 weeks covering the critical healing period, including resistance to fatigue under cyclic loading conditions, as it occurs in patients. The yarns and mesh initial physical and biomechanical properties were characterized. Then, the mesh mechanical strength was evaluated over time. The mechanical properties of the proposed mesh were found to be above the generally recognized threshold value to mechanically support the repair site of a hernia over a 20-week period during in-vitro cyclic loading test. The mesh performance was evaluated in vivo using a published preclinical porcine model of hernia repair at 4-, 12- and 20-weeks post implantation. The burst strength of the hernia repair sites reinforced with the new mesh were higher at 4 & 12 weeks and comparable at 20 weeks to the one of the native abdominal walls. At all time points, the mesh was well tolerated with moderate inflammation and was fast integrated in the abdominal wall at 4 weeks. Particularly, the grips were nicely engulfed in the newly formed connective tissue. They must facilitate the anchoring of the mesh by their extension from the mesh and their mushroom shape. The preclinical data of the self-gripping resorbable mesh suggests that it has all the favorable characteristics for future clinical use during ventral hernia repair open procedures.
Prospective evaluation of poly-4-hydroxybutyrate mesh in CDC class I/high-risk ventral and incisional hernia repair: 18-month follow-up. [2019]Long-term resorbable mesh represents a promising technology for complex ventral and incisional hernia repair (VIHR). Preclinical studies indicate that poly-4-hydroxybutyrate (P4HB) resorbable mesh supports strength restoration of the abdominal wall. This study evaluated outcomes of high-risk subjects undergoing VIHR with P4HB mesh.
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]Long-term resorbable mesh represents a promising technology for ventral and incisional hernia repair (VIHR). This study evaluates poly-4-hydroxybutyrate mesh (P4HB; Phasix Mesh) among comorbid patients with CDC class I wounds.
Retrospective study on the use of a composite mesh (Physiomesh) in laparoscopic ventral hernia repair. [2013]The ideal mesh suited for intraperitoneal placement should address both requirements of tissue separation on the visceral surface and tissue integration on the parietal surface. Meshes with bioresorbable coatings have recently been demonstrated to be successful. In this article, the results are shown of a study with a new type of tissue-separating lightweight mesh with a bioresorbable coating (Physiomesh; Ethicon, Somerville, NJ) in laparoscopic ventral hernia repair. In this single-center retrospective analysis, 88 patients (50 men, 38 women) undergoing hernia surgery between November 16, 2010 and August 10, 2012 at the Imelda Hospital Bonheiden were included. Patients were asked to score their pre- and postoperative pain (1 month after surgery) on a visual analogue scale (VAS), as well as the chronic postoperative pain (pain at more than 6 months after surgery). The time period after which patients were pain free and after which they could return to work was also noted. Our results demonstrate that Physiomesh is a good alternative to the existing meshes leading to significant pain reduction, early return to work, acceptable complications, and low recurrence and reintervention rates.
[Efficacy comparison between ProGrip self-gripping mesh and polypropylene mesh for retromuscular repair of incisional hernias]. [2021]To compare the efficacy of retromuscular repair of incisional hernia by using ProGrip self-gripping mesh and conventional polypropylene mesh.