Incisional Hernia, Incisional Hernia of Midline of Abdomen, Midline Laparotomy
Conditions
Keywords
Incisional Hernia, Prophylactic Mesh, Incisional Hernia of Midline of Abdomen, Midline Laparotomy
Brief summary
The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II). Data from this study will be used to support market applications and European post-market clinical follow-up needs (PMCF). The indication under investigation is reinforcement of midline laparotomy to limit the rate of incisional hernia (IH) in clean and clean-contaminated surgeries (CDC Classification I and II).
Detailed description
The primary objective of this investigation is to evaluate the performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after elective midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II) at 12 months post-operatively and to demonstrate expected performance in terms of rate of IH occurrence relative to a performance goal (based on historical data on primary laparotomy incision suture closure with small bites only). The secondary objectives are to evaluate the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after elective midline laparotomy in clean and clean contaminated fields (CDC Classification I and II) within 60 months postoperatively.
Interventions
DEVICESelf-Gripping Resorbable Mesh
Self-Gripping Resorbable Mesh used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II).
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has provided informed consent. 2. Subject is ≥18 years of age at the time of consent. 3. Subject will be undergoing an elective surgery with a planned/possible midline laparotomy with retrorectus mesh placement. 3a. Subject will be undergoing an elective laparoscopy with a planned possibility of a conversion to midline laparotomy or an elective laparoscopy with a planned possible midline laparotomy for specimen extraction. Pre-Operative
Exclusion criteria
1. Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death 2. Subject has a history of allergic reactions after application of poly-L-lactide, poly-trimethylene carbonate copolymers (PLLA/TMC) 3. Subject is pregnant or is planning pregnancy during study duration period (Females of child-bearing 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 postmenopausal)) 3a. Subject is breastfeeding or is planning to breastfeed during the study duration period 4. Subject is unable or unwilling to comply with the study requirements or follow-up schedule 5. Subject is scheduled for another planned surgery, and subsequent surgery would jeopardize previous application of study treatment 6. Subject with a body mass index (BMI) \> 45 kg/m2 7. Subjects with the following medical interventions/medical conditions are excluded from participation in the study: uncontrolled diabetes (hemoglobin A1c (Hb1Ac) \> 60mmol/mol), cirrhosis, stoma wearers 8. Concomitant ostomy (stoma creation or closure) 9. Subject who had received a mesh in a previous ventral hernia repair or has an existing ventral hernia \> 2 cm 10. Subject with a life expectancy inferior to the study follow-up duration (36 months) 11. Study procedure is a relaparotomy within 30 days of previous abdominal surgery 12. Subject with an American Society of Anesthesiologists (ASA) scores higher than 3 13. Subject has participated in an investigational drug study within the washout period of the drug or in a device study that would interfere with mesh implantation or assessment of Incisional Hernia 14. Subject with current chemo and/or radiation therapy within 2 weeks of procedure Only exclusion of chemotherapeutic drugs that have: * Cytotoxic effect and/or * Inhibit of cell replication and/or * Impaired tissue healing 15. Subject with any history of ascites 16. Subject has a medical condition that precludes the patient from participation in the opinion of the investigator 17. Subject is undergoing a vascular procedure other than abdominal aortic aneurysm (AAA) surgery (i.e, only AAA surgeries accepted) Intraoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional Hernia Rate | 12 months | Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incisional Hernia Rate | 24- and 36-months | Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam |
| Time to Incisional Hernia | From the surgery to the 60-month visit | Time from surgery to incisional hernia |
| Time to other adverse device effects (ADE) | From the surgery to the 60-month visit | Time from skin incision to ADE |
| Incidence of all adverse device effects (ADEs) | Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, 36-, 48- and 60- months | Adverse device effects related to mesh and mesh-augmented reinforcement procedure |
| Incidence of adverse events (AEs) of interest | Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, 36-, 48- and 60- months | AEs of interest: symptomatic seroma requiring action taken, hematoma needing surgical revision, surgical site infection (SSI) defined via the CDC classification of SSI (superficial, deep or organ space), wound dehiscence (skin and/or fascial), mesh removal |
| Pain at the site of surgery evaluated with Numeric Rating Scale (NRS) | baseline (screening), discharge (post-surgery up to 3-mo) and at 3-, 6-, 12-, 24-, and 36- months | Scale from 0-10, with 0 being no pain and 10 being the worst imaginable pain |
| EQ-5D-5L quality of life (QoL) | Baseline and at 3-, 6-, 12-, 24-, and 36- months | Self-administered QOL questionnaire with 5 questions on quality of life and a numeric scale from 0-100 with 0 being the worst health you can imagine and 100 being the best health you can imagine. |
| Surgeon Satisfaction | Day 0, post-operative | Surgeon satisfaction questionnaire on mesh use |
| Hospital length of stay | Hospital admission to hospital discharge (post-surgery up to 3-mo) | Amount of time spent inpatient |
| Readmission and reoperation rate | From the surgery to the 60-month visit | Related to Mesh device and/or Mesh Augmented Reinforcement procedure. |
Countries
Croatia, Germany, Netherlands, Spain, United Kingdom
Contacts
STUDY_CHAIRElisa Mäkäräinen, MD
Oululu University Hospital, Oululu, Finland
Outcome results
None listed