Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia

Launched by MEDTRONIC - MITG · Jun 7, 2024

Keywords

ClinConnect Summary

This clinical trial, called RECOVER, is looking at a special type of mesh called Transorb™ that is designed to help repair ventral hernias, which are bulges in the abdominal wall. The study is focused on patients who are at higher risk for complications due to factors that can affect healing, such as obesity, smoking, or diabetes. The goal is to see how well this mesh works in reinforcing the abdominal wall during surgery. It will take place in both the United States and Europe, and the findings will help determine if this product can be approved for wider use.

To be eligible for the trial, participants must be at least 18 years old and scheduled for a specific type of hernia repair surgery. They should also have at least one condition that could impact their healing after surgery. Participants will undergo a planned surgery where the mesh will be used, and they can expect to be closely monitored throughout the process. This study is important not only for understanding the safety and effectiveness of the Transorb™ mesh but also for improving future hernia repair treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject has provided informed consent
• • 2. Subject is 18 years of age or older at the time of consent
• • 3. Subject is undergoing a planned, elective, open, single-staged repair of a midline primary or incisional ventral hernia using retrorectus/retromuscular mesh placement with or without Transversus Abdominis Release (TAR)
• 4. Subject is expected to meet the criteria for:
• • 1. In the US: a class I / clean wound as defined by the CDC (Centers for Disease Control and Prevention) wound classification
• 2. In Europe: a class I / clean wound or a class II / clean-contaminated wound as defined by the CDC wound classification in compliance with these conditions:
• • No break in the sterile technique, and
• • Entry into gastrointestinal tract with no or minimal spillage
• 5. Subject has at least one of the following comorbid factors impairing wound healing:
• • 1. Current smokers (subject who has smoked 100 cigarettes in his or her lifetime and who currently smokes) Note: Use smoking status prior to preoperative optimization for inclusion assessment.
• • 2. Smokers with a minimum 20 pack year history (including former smokers)
• • 3. Obesity, defined as body Mass Index (BMI) between 30kg/m2 and 39.9kg/m2
• • 4. Chronic Obstructive Pulmonary Disease (COPD)
• • 5. Diabetes mellitus
• • 6. History of wound infection
• • 7. Malnutrition (serum albumin less than 3.4 g/d)
• • 8. Coronary Artery Disease (CAD)
• • 9. History of chemotherapy
• • 10. Diagnosis of hypertension
• • 11. History of malignancy without evidence of active disease
• • 12. Renal insufficiency (serum creatinine concentration ≥2.5 mg/d)
• Pre-Operative Exclusion Criteria Assessed during subject screening:
• • 1. Subject is involved in another interventional drug or device study
• • 2. Subject is unable or unwilling to comply with the study requirements or follow-up schedule
• 3. Subject has a history of:
• • 1. Previous hernia repair involving retrorectus/retromuscular mesh placement or a component separation technique (CST)
• • 2. Allergic reactions to products with PLLA/TMC (Poly-L-lactide, poly-trimethylene carbonate copolymer)
• • 3. Solid organ transplantation
• 4. Subject has current diagnosis/usage of:
• • 1. BMI greater than or equal to 40.0 kg/m2
• • 2. Human Immunodeficiency Virus (HIV)
• • 3. Collagen formation disorder (such as Ehlers-Danlos syndrome and Marfan's syndrome)
• • 4. Liver cirrhosis and/or current ascites
• • 5. Renal disease requiring dialysis
• • 6. Bleeding disorder and/or cannot be removed from anticoagulants prior to surgery based on surgeon discretion and standard-of-care (excluding aspirin)
• • 7. Chronic immunosuppression therapy (10 mg or greater of prednisone or equivalence/ day)
• • 8. Current or anticipated chemotherapy/radiotherapy during study period
• • 9. Stoma
• • 10. Any systemic or local ongoing infection that is uncontrolled and/or requiring treatment such as antimicrobial medication (Note: other uses of antimicrobial medications not excluded)
• • 5. Subject has life expectancy of less than 5 years based on the judgement of investigator
• • 6. Subject is pregnant or is planning pregnancy within the 60-month follow-up period (females of childbearing potential will be required to provide either a urine or serum pregnancy test, except for subjects who are surgically sterile, or are at least 2 years post-menopausal)
• • 7. Subject is breastfeeding or is planning to breastfeed during the study duration period
• • 8. Subject has any other medical condition that precludes the subject from participation, in the opinion of the investigator
• 9. Subject is undergoing:
• • 1. Minimally invasive hernia repair (i.e., laparoscopic or robotic surgery)
• • 2. An emergency surgery (i.e., lifesaving procedures performed where subject is in imminent danger of death)
• • 3. Multi-stage hernia repair
• • 4. Parastomal hernia repair
• • 5. Concomitant ostomy (creation or closure)
• • 6. Any other additional anticipated surgery, if subsequent surgery that would jeopardize previous application of study device, in the opinion of the investigator
• Pre-Operative Exclusion Criteria assessed/confirmed on day of surgery:
• • 10. Subject is American Society of Anesthesiology Class 4, 5, or 6
• • 11. Subject has a BMI greater than or equal 40.0 kg/m2
• • 12. Subject is pregnant or is planning pregnancy within the 60-month follow-up period (females of childbearing potential will be required to provide either a urine or serum pregnancy test, except for subjects who are surgically sterile, or are at least 2 years post-menopausal)
• Intraoperative Exclusion Criteria Assessed by investigator following reduction of hernia and preparation of the retrorectus/ retromuscular space for mesh placement:
• • 1. Subject has existing mesh from previous ventral hernia surgery that investigator was unable to completely remove
• • 2. Subject has concomitant diastasis (\>2 cm) that was not repaired
• • 3. Hernia defect that will require a multi-stage repair
• • 4. Subject no longer meets Inclusion Criteria 4
• • 5. Subject who will require more than a single piece of Transorb™ or any other additional mesh
• 6. Subject with anticipated inability to achieve both:
• • 1. Midline anterior and posterior rectus fascia closure without excessive tension, and
• • 2. Skin closure
• • 7. Subject who is otherwise no longer eligible to receive Transorb™ in open retrorectus/retromuscular position with or without Transversus Abdominis Release (TAR).