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

April 30, 2026 updated by: Medtronic - MITG

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incisional Hernia Rate
Time Frame: 12 months
Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incisional Hernia Rate
Time Frame: 24- and 36-months
Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam
24- and 36-months
Incisional Hernia Rate
Time Frame: 3-, 6-, 12-, 24-, and 36- months
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)
Time Frame: 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
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)
Time Frame: 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.
Baseline and at 3-, 6-, 12-, 24-, and 36- months
Surgeon Satisfaction
Time Frame: Day 0, post-operative
Surgeon satisfaction questionnaire on mesh use
Day 0, post-operative
Hospital length of stay
Time Frame: Hospital admission to hospital discharge (post-surgery up to 3-mo)
Amount of time spent inpatient
Hospital admission to hospital discharge (post-surgery up to 3-mo)
Time to Incisional Hernia
Time Frame: From the surgery to the 60-month visit
Time from surgery to incisional hernia
From the surgery to the 60-month visit
Time to other adverse device effects (ADE)
Time Frame: From the surgery to the 60-month visit
Time from skin incision to ADE
From the surgery to the 60-month visit
Incidence of all adverse device effects (ADEs)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: From the surgery to the 60-month visit
Related to Mesh device and/or Mesh Augmented Reinforcement procedure.
From the surgery to the 60-month visit
Incisional Hernia Rate
Time Frame: 48- and 60-months
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
Time Frame: 48- and 60-months
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
Time Frame: 48- and 60-months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic - MITG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Elisa Mäkäräinen, MD, Oululu University Hospital, Oululu, Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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