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

Multi-center, Single-arm, Prospective Study of Transorb™ Self-Gripping REsorbable Mesh in High-risk subjeCts Undergoing Open Repair of VEntral heRnia

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hernia; Hernia, Abdominal; Hernia, Ventral; Hernia Abdominal Wall
• Intervention / Treatment: Device: Transorb™ Self-Gripping Resorbable Mesh

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • UZ Leuven, Campus Gasthuisberg
• France
  • Colombes, France, 92700
    • APHP Hospital Louis Mourier
  • Lille, France
    • Centre Hospitalier Universitaire De Lille
  • Lyon, France
    • Hospices Civils de Lyon
  • Reims, France
    • Centre Hospitalier Universitaire de Reims
  • Rouen, France
    • Hôpital Charles Nicolle Centre Hospitalier Universitaire de Rouen
  • Strasbourg, France
    • Hôpitaux Universitaires de Strasbourg
• United States
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Novant Health New Hanover Regional Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Virginia
    • Newport News, Virginia, United States, 23606
      • TPMG General Surgery and Hernia Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hernia Repair; single arm study, no control arm	Device: Transorb™ Self-Gripping Resorbable Mesh; Self-Gripping Resorbable Mesh used for repair of open ventral hernia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of clinical hernia recurrence	Occurrence of clinical hernia recurrence evaluated by physical examination and confirmed, if deemed necessary by a study investigator, following site standard of care medical imaging for hernia evaluation.	within 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of clinical hernia recurrence	Occurrence of clinical hernia recurrence evaluated by physical examination and confirmed, if deemed necessary by a study investigator, following site standard of care medical imaging for hernia evaluation.	within 1, 6, 24, 36, 48 and 60 months
Rate of clinical hernia recurrence requiring re-operation	Occurrence of operative procedures performed with the specific goal of repairing a recurrent hernia	within 1, 6, 12, 24, 36, 48 and 60 months
Time to hernia recurrence	Days/months to hernia recurrence measured from study procedure to clinical hernia recurrence	Day 0 (day of surgery) through the 60-month visit
Rate of mesh removal related to study device and/or study procedure	Occurrence of study mesh removal related to study device and/or study procedure (defined as study device implantation following reduction of hernia and preparation of the retrorectus/retromuscular space)	within 1, 6, 12, 24, 36, 48 and 60 months
Surgeon satisfaction	Surgeon satisfaction questionnaire on mesh use	Day 0 (day of surgery)
Rate of surgical site occurrence (SSO)	Occurrence of SSO defined as seroma, hematoma, wound dehiscence, or surgical site infection (SSI) that are adverse events related to study device and/or study procedure (defined as study device implantation following reduction of hernia and preparation of the retrorectus/retromuscular space)	at discharge (post-surgery up to 1-mo), and within 1, 6, 12, 24, 36, 48 and 60 months
Rate of surgical site occurrence (SSO) requiring a procedural intervention (SSOPI)	Occurrence of SSO defined as seroma, hematoma, wound dehiscence, or surgical site infection (SSI) that are adverse events related to study device and/or study procedure (defined as study device implantation following reduction of hernia and preparation of the retrorectus/retromuscular space) and requiring a procedural intervention (defined as percutaneous drainage, wound opening or debridement, suture excision, or mesh removal (partial or total))	at discharge (post-surgery up to 1-mo), and within 1, 6, 12, 24, 36, 48 and 60 months
Hospital length of inpatient stay	days spent inpatient	discharge (post-surgery up to 1-mo)
Rate of hernia recurrence reported by subjects	Occurrence of subject-reported hernia recurrence through the Ventral Hernia Recurrence Inventory (VHRI)	at 36, 48 and 60 months
Change in subject quality of life (QoL)	Change in subject quality of life (QoL), as measured by the Abdominal Hernia-Q (AHQ) Quality-of-Life survey patient-reported outcome measure	baseline compared to 1, 6, 12, 24, 36, 48 and 60 months.
Change in subject-reported pain	Change in subject-reported pain at the hernia site using a Pain Numeric Rating Scale (NRS) from 0-10, with 0 being no pain and 10 being the worst possible pain	baseline compared to 1, 6, 12, 24, 36, 48 and 60 months.

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Study Chair: Matthew Goldblatt, MD, FACS, Medical College of Wisconsin; Study Chair: Bruce Ramshaw, MD, FACS; Study Chair: J. Scott Roth, MD, FACS, University of Kentucky; Study Chair: Frederik Berrevoet, Prof. Dr., University Hospital, Ghent; Study Chair: Yohann Renard, Prof., CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hernia; Hernia, Ventral; Hernia Recurrence; Hernia, Abdominal; Hernia Abdominal Wall
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Internal Hernia; Hernia; Hernia, Abdominal; Hernia, Ventral
• Other Study ID Numbers: MDT21008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No