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New mesh aims to stop hernias after belly surgery

NCT ID NCT05424484

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a special mesh that dissolves over time, placed along the suture line after a midline abdominal incision. The goal is to see if it lowers the chance of developing an incisional hernia. About 123 adults having planned or possible open abdominal surgery will receive the mesh and be followed for hernia occurrence using exams and ultrasound.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Self-gripping resorbable mesh (Deternia™)
What this could lead to
If successful, this mesh could become a standard way to prevent incisional hernias after abdominal surgery, reducing the need for additional operations.
What could go wrong
This is a single-arm study with no comparison group, so benefits may be overstated. The mesh is new and long-term safety data are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

123 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Incisional Hernia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Barmherzige Brüder Regensburg

    Regensburg, 93049, Germany

  • Cardiff and Vale University Local Health Board

    Cardiff, CF14 4XW, United Kingdom

  • Clinical Hospital Center Sisters of Mercy

    Zagreb, 10000, Croatia

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

    Igualada, Barcelona, 08700, Spain

  • Countess Of Chester Hospital NHS Foundation Trust

    Chester, Cheshire, CH2 1HJ, United Kingdom

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • IJsselland Ziekenhuis

    Capelle aan den IJssel, Netherlands

  • Klinikum Braunschweig

    Braunschweig, 38118, Germany

  • Maastricht University Medical Center

    Maastricht, 6229, Netherlands

  • Pius-Hospital Medical Campus University of Oldenburg

    Oldenburg, 26121, Germany

  • University Hospital Center of Zagreb

    Zagreb, 10000, Croatia

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