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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Incisional Hernia; Incisional Hernia of Midline of Abdomen; Midline Laparotomy
• Intervention / Treatment: Device: Self-Gripping Resorbable Mesh

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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Clinical Hospital Center Sisters of Mercy
  • Zagreb, Croatia, 10000
    • University Hospital Center of Zagreb
• Germany
  • Braunschweig, Germany, 38118
    • Klinikum Braunschweig
  • Oldenburg, Germany, 26121
    • Pius-Hospital Medical Campus University of Oldenburg
  • Regensburg, Germany, 93049
    • Barmherzige Brüder Regensburg
• Netherlands
  • Capelle aan den IJssel, Netherlands
    • IJsselland Ziekenhuis
  • Maastricht, Netherlands, 6229
    • Maastricht University Medical Center
• Spain
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Barcelona
    • Igualada, Barcelona, Spain, 08700
      • Consorci Sanitari de l'Anoia Hospital Universitari d'Igualada
• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • Cardiff and Vale University Local Health Board
  • Cheshire
    • Chester, Cheshire, United Kingdom, CH2 1HJ
      • Countess Of Chester Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• 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 prevention cohort; single arm study, no control arm	Device: Self-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).

What is the study measuring?

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
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)
Time to Incisional Hernia	Time from surgery to incisional hernia	From the surgery to the 60-month visit
Time to other adverse device effects (ADE)	Time from skin incision to ADE	From the surgery to the 60-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-, 36-, 48- and 60- 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-, 36-, 48- and 60- months
Readmission and reoperation rate	Related to Mesh device and/or Mesh Augmented Reinforcement procedure.	From the surgery to the 60-month visit
Incisional Hernia Rate	Occurrence of incisional hernia when suspected during phone call follow-up visits and subsequently assessed by clinical examination and abdominal ultrasound exam	48- and 60-months
Incisional Hernia Rate	Occurrence of incisional hernia when suspected during phone call follow-up visits and subsequently assessed by clinical examination	48- and 60-months
Incisional Hernia Rate	Occurrence of incisional hernia reported by subjects through the "modified " PROMID questionnaire administered at phone call follow-up visits	48- and 60-months

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Study Chair: Elisa Mäkäräinen, MD, Oululu University Hospital, Oululu, Finland

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Actual): April 17, 2026
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Incisional Hernia; Prophylactic Mesh; Incisional Hernia of Midline of Abdomen; Midline Laparotomy
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Hernia; Pathological Conditions, Signs and Symptoms; Incisional Hernia
• Other Study ID Numbers: MDT20049MARS; CIV-22-05-039590 (Other Identifier: Eudamed)

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: No
• product manufactured in and exported from the U.S.: No