New mesh aims to stop hernias after belly surgery
NCT ID NCT05424484
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
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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
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123 people
The number who actually took part.
- Started
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Nov 2022
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Barmherzige Brüder Regensburg
Regensburg, 93049, Germany
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Cardiff and Vale University Local Health Board
Cardiff, CF14 4XW, United Kingdom
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Clinical Hospital Center Sisters of Mercy
Zagreb, 10000, Croatia
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Consorci Sanitari de l'Anoia Hospital Universitari d'Igualada
Igualada, Barcelona, 08700, Spain
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Countess Of Chester Hospital NHS Foundation Trust
Chester, Cheshire, CH2 1HJ, United Kingdom
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Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
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Hospital Universitario Virgen Macarena
Seville, 41009, Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
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IJsselland Ziekenhuis
Capelle aan den IJssel, Netherlands
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Klinikum Braunschweig
Braunschweig, 38118, Germany
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Maastricht University Medical Center
Maastricht, 6229, Netherlands
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Pius-Hospital Medical Campus University of Oldenburg
Oldenburg, 26121, Germany
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University Hospital Center of Zagreb
Zagreb, 10000, Croatia
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Other studies related to the condition(s) this trial covers.
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- Can a flap made from the hernia sac itself prevent mesh complications?