Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence (MARS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05424484 |
Recruitment Status :
Recruiting
First Posted : June 21, 2022
Last Update Posted : February 13, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Incisional Hernia Incisional Hernia of Midline of Abdomen Midline Laparotomy | Device: Self-Gripping Resorbable Mesh | Not Applicable |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Mesh Augmented Reinforcement of Abdominal Wall Suture Line in Patients Undergoing Midline Laparotomy to Limit the Rate of Incisional Hernia Occurrence |
Actual Study Start Date : | November 10, 2022 |
Estimated Primary Completion Date : | May 2025 |
Estimated Study Completion Date : | September 2028 |
Arm | Intervention/treatment |
---|---|
Experimental: Hernia prevention cohort
single arm study, no control arm
|
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). |
- Incisional Hernia Rate [ Time Frame: 12 months ]Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
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:
- 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
Only exclusion of chemotherapeutic drugs that have:
- Cytotoxic effect and/or
- Inhibit of cell replication and/or
- Impaired tissue healing
- Subject with any history of ascites
- Subject has a medical condition that precludes the patient from participation in the opinion of the investigator
- Subject is undergoing a vascular procedure other than abdominal aortic aneurysm (AAA) surgery (i.e, only AAA surgeries accepted)
Intraoperative Exclusion criteria
- Subject's study procedure is in a contaminated or infected site as assessed by the Investigator(s) (CDC Class 3 and 4)
- Abdomen is left open at the end of the procedure
- Subject has an unsuspected ventral hernia >2cm encountered at the time of laparotomy
- Inability to close the anterior fascia or keep the mesh securely out of the peritoneal cavity
- Second-look procedure planned
- Cases requiring a full-thickness partial resection of the abdominal wall (in particular the midline) because of involvement in neoplastic process or complex fistula
- Inoperable tumor/poor prognostic cancer/patient non curatively treated
- Subject has a suture length to wound length ratio< 3.5/1
- Subject has any ongoing infection at the time of the surgery, that is uncontrolled and/or requiring treatment such as antibiotics
- Subject was not implanted with Deternia™ Self Gripping Resorbable Mesh
- Subject requires more than 1 mesh
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05424484
Contact: Ruth Larbre | +33 678213945 | ruth.larbre@medtronic.com | |
Contact: Study Mailbox | rs.marsstudy@medtronic.com |
Croatia | |
Clinical Hospital Center Sisters of Mercy | Terminated |
Zagreb, Croatia, 10000 | |
University Hospital Center of Zagreb | Recruiting |
Zagreb, Croatia, 10000 | |
Contact: Predrag Pavic, PhD | |
Germany | |
Klinikum Braunschweig | Terminated |
Braunschweig, Germany, 38118 | |
Pius-Hospital Medical Campus University of Oldenburg | Recruiting |
Oldenburg, Germany, 26121 | |
Contact: Dirk Weyhe, PhD | |
Barmherzige Brüder Regensburg | Recruiting |
Regensburg, Germany, 93049 | |
Contact: Markus Steinbauer, PhD | |
Netherlands | |
IJsselland Ziekenhuis | Recruiting |
Capelle aan den IJssel, Netherlands | |
Contact: Steve Buijk, PhD | |
Maastricht University Medical Center | Recruiting |
Maastricht, Netherlands, 6229 | |
Contact: Nicole Bouvy, PhD | |
Spain | |
Consorci Sanitari de l'Anoia Hospital Universitari d'Igualada | Recruiting |
Igualada, Barcelona, Spain, 08700 | |
Contact: Ruben Hernando Tavira, PhD | |
Hospital de la Santa Creu i Sant Pau | Recruiting |
Barcelona, Spain, 08041 | |
Contact: Jose Antonio Gonzalez Lopez, PhD | |
Principal Investigator: Jose Antonio Gonzalez Lopez, PhD | |
Hospital Universitario Ramón y Cajal | Recruiting |
Madrid, Spain, 28034 | |
Contact: Jose Manuel Molina Villar, MD | |
Principal Investigator: Jose Manuel Molina Villar, MD | |
Hospital Universitario Virgen Macarena | Recruiting |
Sevilla, Spain, 41009 | |
Contact: Juan Bellido Luque, MD | |
Principal Investigator: Juan Bellido Luque, MD | |
United Kingdom | |
Countess Of Chester Hospital NHS Foundation Trust | Recruiting |
Chester, Cheshire, United Kingdom, CH2 1HJ | |
Contact: Dale Vimalachandran, MD | |
Principal Investigator: Dale Vimalachandran, MD | |
Cardiff and Vale University Local Health Board | Recruiting |
Cardiff, United Kingdom, CF14 4XW | |
Contact: Jared Torkington, MD | |
Principal Investigator: Jared Torkington, MD |
Study Chair: | Jose M Molina, Dr | Hospital Universitario Ramon y Cajal, Madrid, Spain |
Responsible Party: | Medtronic - MITG |
ClinicalTrials.gov Identifier: | NCT05424484 |
Other Study ID Numbers: |
MDT20049MARS CIV-22-05-039590 ( Other Identifier: Eudamed ) |
First Posted: | June 21, 2022 Key Record Dates |
Last Update Posted: | February 13, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Incisional Hernia Prophylactic Mesh Incisional Hernia of Midline of Abdomen Midline Laparotomy |
Hernia Incisional Hernia Pathological Conditions, Anatomical Postoperative Complications Pathologic Processes |