Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence

Study Overview
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Brief Summary
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The purpose of this prospective, pivotal, multi-center, single-arm cohort, 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. 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
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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 36 months postoperatively.

Official Title
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Mesh Augmented Reinforcement of Abdominal Wall Suture Line in Patients Undergoing Midline Laparotomy to Limit the Rate of Incisional Hernia Occurrence

Conditions
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Incisional Hernia, Incisional Hernia of Midline of Abdomen, Midline Laparotomy

Intervention / Treatment
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* Device: Self-Gripping Resorbable Mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided informed consent. Subject is ≥18 years of age at the time of consent. Subject will be undergoing an elective surgery with a planned midline laparotomy with retrorectus mesh placement. Pre-Operative Exclusion Criteria: Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death Subject has a history of allergic reactions after application of poly-L-lactide, poly-trimethylene carbonate copolymers (PLLA/TMC) 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)) Subject is unable or unwilling to comply with the study requirements or follow-up schedule Subject is scheduled for another planned surgery, and subsequent surgery would jeopardize previous application of study treatment Subject with a body mass index (BMI) > 45 kg/m2 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 Concomitant ostomy (stoma creation or closure) Subject who had received a mesh in a previous ventral hernia repair or has an existing ventral hernia. Subject with a life expectancy inferior to the study follow-up duration (36 months) Study procedure is a relaparotomy within 30 days of previous abdominal surgery Subject with an American Society of Anesthesiologists (ASA) scores higher than 3 Subject has participated in an investigation drug or device study within 30 days of enrolment Subject with current chemo and/or radiation therapy within 2 weeks of procedure Subject with history of ascites Subject has a medical condition that precludes the patient from participation in the opinion of the investigator Subject is undergoing a vascular procedure other than abdominal aortic aneurysm (AAA) surgery (i.e, only AAA surgeries accepted) Intraoperative Exclusion criteria Subject's study procedure is in a contaminated or infected site as assessed by the Investigator(s) (CDC Class 3 and 4) Abdomen is left open at the end of the procedure Subject has an unsuspected ventral hernia >1cm encountered at the time of laparotomy Inability to close the anterior fascia or keep the mesh securely out of the peritoneal cavity Second-look procedure planned Cases requiring a full-thickness partial resection of the abdominal wall (in particular the midline) because of involvement in neoplastic process or complex fistula Inoperable tumor/poor prognostic cancer/patient non curatively treated Subject has a suture length to wound length ratio< 3.5/1 Subject has any ongoing infection at the time of the surgery, that is uncontrolled and/or requiring treatment such as antibiotics Subject was not implanted with Deternia™ Self Gripping Resorbable Mesh Subject requires more than 1 mesh

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hernia prevention cohort<br>single arm study, no control arm | Device: Self-Gripping Resorbable Mesh<br>* Self-Gripping Resorbable Mesh used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional Hernia Rate | Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional Hernia Rate | Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam | 24- and 36-months | 
| Incisional Hernia Rate | Occurrence of incisional hernia assessed by clinical examination | 3-, 6-, 12-, 24-, and 36- months | 
| Time to Incisional Hernia | Time from surgery to incisional hernia | From the surgery to the 36-month visit | 
| Time to other adverse device effects (ADE) | Time from skin incision to ADE | From the surgery to the 36-month visit | 
| Incidence of all adverse device effects (ADEs) | Adverse device effects related to mesh and mesh-augmented reinforcement procedure | Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months | 
| Incidence of adverse events (AEs) of interest | 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 | Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months | 
| Pain at the site of surgery evaluated with Numeric Rating Scale (NRS) | Scale from 0-10, with 0 being no pain and 10 being the worst imaginable pain | baseline (screening), discharge (post-surgery up to 3-mo) and at 3-, 6-, 12-, 24-, and 36- months | 
| EQ-5D-5L quality of life (QoL) | 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. | Baseline and at 3-, 6-, 12-, 24-, and 36- months | 
| Surgeon Satisfaction | Surgeon satisfaction questionnaire on mesh use | Day 0, post-operative | 
| Hospital length of stay | Amount of time spent inpatient | Hospital admission to hospital discharge (post-surgery up to 3-mo) | 
| Readmission and reoperation rate | Related to Mesh device and/or Mesh Augmented Reinforcement procedure. | From the surgery to the 36-month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incisional Hernia, Prophylactic Mesh, Incisional Hernia of Midline of Abdomen, Midline Laparotomy