transorb™ self-gripping resorbable mesh in high-risk subjects undergoing open repair of ventral hernia

Conditions: Hernia; Hernia, Ventral; Hernia, Abdominal; Hernia Abdominal Wall

Summary: 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.

the primary objective of the study is to evaluate the performance (hernia clinical recurrence rate) of transorb™ mesh within 12 months post-operatively when the mesh is used for repair of open ventral hernia. the secondary objectives of the study are to evaluate the safety and performance of transorb™ mesh when used for repair of open ventral hernia within 60 months post-operatively.

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).

Keywords: hernia recurrence hernia hernia, ventral hernia, abdominal hernia abdominal wall