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Clinical Trials in the UK / NCT05424484
Active, not recruiting Not applicable

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

NCT05424484 · tracked via the Priya Life Science UK tracker
Sponsor
Medtronic - MITG
Phase
Not applicable
Started
2022-11-22
Last updated
2026-05-06

Condition(s) studied

Incisional HerniaIncisional Hernia of Midline of AbdomenMidline Laparotomy

Investigational drug(s) / intervention(s)

Self-Gripping Resorbable Mesh

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).

Study 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 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Clinical Hospital Center Sisters of Mercy Zagreb Croatia
University Hospital Center of Zagreb Zagreb Croatia
Klinikum Braunschweig Braunschweig Germany
Pius-Hospital Medical Campus University of Oldenburg Oldenburg Germany
Barmherzige Brüder Regensburg Regensburg Germany
IJsselland Ziekenhuis Capelle aan den IJssel Netherlands
Maastricht University Medical Center Maastricht Netherlands
Consorci Sanitari de l'Anoia Hospital Universitari d'Igualada Igualada Barcelona
Hospital de la Santa Creu i Sant Pau Barcelona Spain
Hospital Universitario Ramón y Cajal Madrid Spain
Hospital Universitario Virgen Macarena Seville Spain
Countess Of Chester Hospital NHS Foundation Trust Chester Cheshire
Cardiff and Vale University Local Health Board Cardiff United Kingdom

More Medtronic - MITG trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05424484 on ClinicalTrials.gov ↗ ← All trials in the UK