Clinical trial NCT05424484: Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence
Official title: Mesh Augmented Reinforcement of Abdominal Wall Suture Line in Patients Undergoing Midline Laparotomy to Limit the Rate of Incisional Hernia Occurrence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Incisional Hernia
Incisional Hernia of Midline of Abdomen
Midline Laparotomy
Keywords: Incisional Hernia
Prophylactic Mesh
Incisional Hernia of Midline of Abdomen
Midline Laparotomy
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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. 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 36 months postoperatively.

Eligibility criteria: 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 Exclusion criteria

1. Subject's study procedure is in a contaminated or infected site as assessed by the Investigator(s) (CDC Class 3 and 4)
2. Abdomen is left open at the end of the procedure
3. Subject has an unsuspected ventral hernia \>2cm encountered at the time of laparotomy
4. Inability to close the anterior fascia or keep the mesh securely out of the peritoneal cavity
5. Second-look procedure planned
6. Cases requiring a full-thickness partial resection of the abdominal wall (in particular the midline) because of involvement in neoplastic process or complex fistula
7. Inoperable tumor/poor prognostic cancer/patient non curatively treated
8. Subject has a suture length to wound length ratio\< 3.5/1
9. Subject has any ongoing infection at the time of the surgery, that is uncontrolled and/or requiring treatment such as antibiotics
10. Subject was not implanted with Deternia™ Self Gripping Resorbable Mesh
11. Subject requires more than 1 mesh

Primary outcomes:
measure: Incisional Hernia Rate
timeFrame: 12 months
Secondary outcomes:
measure: Incisional Hernia Rate
timeFrame: 24- and 36-months
measure: Incisional Hernia Rate
timeFrame: 3-, 6-, 12-, 24-, and 36- months
measure: Time to Incisional Hernia
timeFrame: From the surgery to the 36-month visit
measure: Time to other adverse device effects (ADE)
timeFrame: From the surgery to the 36-month visit
measure: Incidence of all adverse device effects (ADEs)
timeFrame: Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months
measure: Incidence of adverse events (AEs) of interest
timeFrame: Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months
measure: Pain at the site of surgery evaluated with Numeric Rating Scale (NRS)
timeFrame: baseline (screening), discharge (post-surgery up to 3-mo) and at 3-, 6-, 12-, 24-, and 36- months
measure: EQ-5D-5L quality of life (QoL)
timeFrame: Baseline and at 3-, 6-, 12-, 24-, and 36- months
measure: Surgeon Satisfaction
timeFrame: Day 0, post-operative
measure: Hospital length of stay
timeFrame: Hospital admission to hospital discharge (post-surgery up to 3-mo)
measure: Readmission and reoperation rate
timeFrame: From the surgery to the 36-month visit
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Center Sisters of Mercy
city: Zagreb
country: Croatia
facility: University Hospital Center of Zagreb
city: Braunschweig
country: Germany
facility: Klinikum Braunschweig
city: Oldenburg
country: Germany
facility: Pius-Hospital Medical Campus University of Oldenburg
city: Regensburg
country: Germany
facility: Barmherzige Brüder Regensburg
city: Capelle aan den IJssel
country: Netherlands
facility: IJsselland Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Igualada
country: Spain
facility: Consorci Sanitari de l'Anoia Hospital Universitari d'Igualada
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Chester
country: United Kingdom
facility: Countess Of Chester Hospital NHS Foundation Trust
state: Cheshire
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Local Health Board
Study officials:
affiliation: Oululu University Hospital, Oululu, Finland
name: Elisa Mäkäräinen, MD
role: STUDY_CHAIR
References: