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

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ClinicalTrials.gov Identifier: NCT05424484
Recruitment Status : Recruiting
First Posted : June 21, 2022
Last Update Posted : February 13, 2024
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Tracking Information
First Submitted Date  ICMJE May 18, 2022
First Posted Date  ICMJE June 21, 2022
Last Update Posted Date February 13, 2024
Actual Study Start Date  ICMJE November 10, 2022
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2022)		 Incisional Hernia Rate [ Time Frame: 12 months ]
Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2022)
  • Incisional Hernia Rate [ Time Frame: 24- and 36-months ]
    Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam
  • Incisional Hernia Rate [ Time Frame: 3-, 6-, 12-, 24-, and 36- months ]
    Occurrence of incisional hernia assessed by clinical examination
  • Time to Incisional Hernia [ Time Frame: From the surgery to the 36-month visit ]
    Time from surgery to incisional hernia
  • Time to other adverse device effects (ADE) [ Time Frame: From the surgery to the 36-month visit ]
    Time from skin incision to ADE
  • Incidence of all adverse device effects (ADEs) [ Time Frame: Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months ]
    Adverse device effects related to mesh and mesh-augmented reinforcement procedure
  • Incidence of adverse events (AEs) of interest [ Time Frame: Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months ]
    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
  • Pain at the site of surgery evaluated with Numeric Rating Scale (NRS) [ Time Frame: baseline (screening), discharge (post-surgery up to 3-mo) and at 3-, 6-, 12-, 24-, and 36- months ]
    Scale from 0-10, with 0 being no pain and 10 being the worst imaginable pain
  • EQ-5D-5L quality of life (QoL) [ Time Frame: Baseline and at 3-, 6-, 12-, 24-, and 36- months ]
    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.
  • Surgeon Satisfaction [ Time Frame: Day 0, post-operative ]
    Surgeon satisfaction questionnaire on mesh use
  • Hospital length of stay [ Time Frame: Hospital admission to hospital discharge (post-surgery up to 3-mo) ]
    Amount of time spent inpatient
  • Readmission and reoperation rate [ Time Frame: From the surgery to the 36-month visit ]
    Related to Mesh device and/or Mesh Augmented Reinforcement procedure.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence
Official Title  ICMJE Mesh Augmented Reinforcement of Abdominal Wall Suture Line in Patients Undergoing Midline Laparotomy to Limit the Rate of Incisional Hernia Occurrence
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. 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).
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 36 months postoperatively.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Incisional Hernia
  • Incisional Hernia of Midline of Abdomen
  • Midline Laparotomy
Intervention  ICMJE Device: 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 Arms  ICMJE Experimental: Hernia prevention cohort
single arm study, no control arm
Intervention: Device: Self-Gripping Resorbable Mesh
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2022)		 120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2028
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ruth Larbre +33 678213945 ruth.larbre@medtronic.com
Contact: Study Mailbox rs.marsstudy@medtronic.com
Listed Location Countries  ICMJE Croatia,   Germany,   Netherlands,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05424484
Other Study ID Numbers  ICMJE MDT20049MARS
CIV-22-05-039590 ( Other Identifier: Eudamed )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Medtronic - MITG
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medtronic - MITG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jose M Molina, Dr Hospital Universitario Ramon y Cajal, Madrid, Spain
PRS Account Medtronic - MITG
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP