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

NCT05424484 | Active Not Recruiting

• 2 other identifiers: MDT20049MARSCIV-22-05-039590
• Study Type: interventional
• Target: 123
• Locations: 5 countries
• Sites: 13

Brief 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).

Conditions

Incisional Hernia; Incisional Hernia of Midline of Abdomen; Midline Laparotomy

Keywords

Incisional Hernia; Prophylactic Mesh; Incisional Hernia of Midline of Abdomen; Midline Laparotomy

Outcome Measures

Primary Outcomes (1)

• Incisional Hernia Rate

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

  12 months

Secondary Outcomes (14)

• Incisional Hernia Rate

  24- and 36-months

• Incisional Hernia Rate

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

• Time to Incisional Hernia

  From the surgery to the 60-month visit

• Time to other adverse device effects (ADE)

  From the surgery to the 60-month visit

• Incidence of all adverse device effects (ADEs)

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

Study Arms (1)

Hernia prevention cohort

EXPERIMENTAL

single arm study, no control arm

Device: Self-Gripping Resorbable Mesh

Interventions

Self-Gripping Resorbable Mesh DEVICE

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

Hernia prevention cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• a. 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.

You may not qualify if:

• Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death
• 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
• Cytotoxic effect and/or

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (13)

Clinical Hospital Center Sisters of Mercy

Zagreb, 10000, Croatia

Location

University Hospital Center of Zagreb

Zagreb, 10000, Croatia

Location

Klinikum Braunschweig

Braunschweig, 38118, Germany

Location

Pius-Hospital Medical Campus University of Oldenburg

Oldenburg, 26121, Germany

Location

Barmherzige Brüder Regensburg

Regensburg, 93049, Germany

Location

IJsselland Ziekenhuis

Capelle aan den IJssel, Netherlands

Location

Maastricht University Medical Center

Maastricht, 6229, Netherlands

Location

Consorci Sanitari de l'Anoia Hospital Universitari d'Igualada

Igualada, Barcelona, 08700, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Countess Of Chester Hospital NHS Foundation Trust

Chester, Cheshire, CH2 1HJ, United Kingdom

Location

Cardiff and Vale University Local Health Board

Cardiff, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Elisa Mäkäräinen, MD

  Oululu University Hospital, Oululu, Finland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: June 21, 2022
• Study Start: November 22, 2022
• Primary Completion: April 17, 2026
• Study Completion (Estimated): November 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); CR (2); GB (2); ES (4); NL (2)