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Incisional HerniaMARSNCT05424484

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

A study testing Self-Gripping Resorbable Mesh in people with Incisional Hernia and Incisional Hernia of Midline of Abdomen, run by Medtronic - MITG at 13 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Self-Gripping Resorbable Mesh
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
13 sitesin 5 countries
Study dates
22 Nov 2022to Nov 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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/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:
  • Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death
Show all 38Show fewer
  • 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)) 3a. Subject is breastfeeding or is planning to breastfeed during the study duration period
  • 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 > 2 cm
  • 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 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
  • 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
  • Subject with any 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 >2cm 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

Who cannot join

None listed.

Trial locations and contacts

13 sites in 5 countries.

13 sites in 5 countries

Spain4 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Consorci Sanitari de l'Anoia Hospital Universitari d'Igualada

    Igualada, Barcelona, 08700

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

Germany3 sites

  • Klinikum Braunschweig

    Braunschweig, 38118

  • Pius-Hospital Medical Campus University of Oldenburg

    Oldenburg, 26121

  • Barmherzige Brüder Regensburg

    Regensburg, 93049

Other trials in Germany

Croatia2 sites

  • Clinical Hospital Center Sisters of Mercy

    Zagreb, 10000

  • University Hospital Center of Zagreb

    Zagreb, 10000

Other trials in Croatia

Netherlands2 sites

  • IJsselland Ziekenhuis

    Capelle aan den IJssel

  • Maastricht University Medical Center

    Maastricht, 6229

Other trials in Netherlands

United Kingdom2 sites

  • Cardiff and Vale University Local Health Board

    Cardiff, CF14 4XW

  • Countess Of Chester Hospital NHS Foundation Trust

    Chester, Cheshire, CH2 1HJ

Other trials in United Kingdom

About this study

Official title: 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).

Read the 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.

Being tested
Self-Gripping Resorbable Mesh
Keywords
Incisional Hernia, Prophylactic Mesh, Incisional Hernia of Midline of Abdomen, Midline Laparotomy
Medical subject headings
Incisional Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-Gripping Resorbable MeshDevice

    Self-Gripping Resorbable Mesh used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II).

Study groups in NCT05424484
Study groupRoleWhat they receive
Hernia prevention cohortExperimentalsingle arm study, no control arm
Receives: Device: Self-Gripping Resorbable Mesh

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incisional Hernia Rate

    Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam

    Measured: 12 months

Secondary outcomes (14)

  1. Incisional Hernia Rate

    Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam

    Measured: 24- and 36-months

  2. Incisional Hernia Rate

    Occurrence of incisional hernia assessed by clinical examination

    Measured: 3-, 6-, 12-, 24-, and 36- months

  3. Time to Incisional Hernia

    Time from surgery to incisional hernia

    Measured: From the surgery to the 60-month visit

  4. Time to other adverse device effects (ADE)

    Time from skin incision to ADE

    Measured: From the surgery to the 60-month visit

  5. Incidence of all adverse device effects (ADEs)

    Adverse device effects related to mesh and mesh-augmented reinforcement procedure

    Measured: Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, 36-, 48- and 60- months

  6. 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

    Measured: Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, 36-, 48- and 60- months

  7. 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

    Measured: baseline (screening), discharge (post-surgery up to 3-mo) and at 3-, 6-, 12-, 24-, and 36- months

  8. 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.

    Measured: Baseline and at 3-, 6-, 12-, 24-, and 36- months

  9. Surgeon Satisfaction

    Surgeon satisfaction questionnaire on mesh use

    Measured: Day 0, post-operative

  10. Hospital length of stay

    Amount of time spent inpatient

    Measured: Hospital admission to hospital discharge (post-surgery up to 3-mo)

  11. Readmission and reoperation rate

    Related to Mesh device and/or Mesh Augmented Reinforcement procedure.

    Measured: From the surgery to the 60-month visit

  12. 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

    Measured: 48- and 60-months

  13. Incisional Hernia Rate

    Occurrence of incisional hernia when suspected during phone call follow-up visits and subsequently assessed by clinical examination

    Measured: 48- and 60-months

  14. Incisional Hernia Rate

    Occurrence of incisional hernia reported by subjects through the "modified " PROMID questionnaire administered at phone call follow-up visits

    Measured: 48- and 60-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start22 Nov 2022
  3. Primary completion17 Apr 2026
  4. Study completionNov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05424484
Sponsor's protocol ID
MDT20049MARS
Other IDs
CIV-22-05-039590
Acronym
MARS
Status last verified
Apr 2026
First submitted
18 May 2022
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-Gripping Resorbable Mesh in people with Incisional Hernia and Incisional Hernia of Midline of Abdomen, run by Medtronic - MITG at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain, Germany, Croatia, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incisional Hernia Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05424484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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