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

Incisional Hernia Clinical Trial

— MARS  

Official title:

Mesh Augmented Reinforcement of Abdominal Wall Suture Line in Patients Undergoing Midline Laparotomy to Limit the Rate of Incisional Hernia Occurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05424484
• Other study ID #: MDT20049MARS
• Secondary ID: CIV-22-05-039590
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: September 2028

Study information

• Verified date: February 2024
• Source: Medtronic - MITG
• Contact: Ruth Larbre
• Phone: +33 678213945
• Email: ruth.larbre[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2028
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Incisional Hernia of Midline of Abdomen
• Midline Laparotomy

Intervention

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).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

Croatia,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional Hernia Rate	Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam	12 months
Secondary	Incisional Hernia Rate	Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam	24- and 36-months
Secondary	Incisional Hernia Rate	Occurrence of incisional hernia assessed by clinical examination	3-, 6-, 12-, 24-, and 36- months
Secondary	Time to Incisional Hernia	Time from surgery to incisional hernia	From the surgery to the 36-month visit
Secondary	Time to other adverse device effects (ADE)	Time from skin incision to ADE	From the surgery to the 36-month visit
Secondary	Incidence of all adverse device effects (ADEs)	Adverse device effects related to mesh and mesh-augmented reinforcement procedure	Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months
Secondary	Incidence of adverse events (AEs) of interest	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	Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months
Secondary	Pain at the site of surgery evaluated with Numeric Rating Scale (NRS)	Scale from 0-10, with 0 being no pain and 10 being the worst imaginable pain	baseline (screening), discharge (post-surgery up to 3-mo) and at 3-, 6-, 12-, 24-, and 36- months
Secondary	EQ-5D-5L quality of life (QoL)	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.	Baseline and at 3-, 6-, 12-, 24-, and 36- months
Secondary	Surgeon Satisfaction	Surgeon satisfaction questionnaire on mesh use	Day 0, post-operative
Secondary	Hospital length of stay	Amount of time spent inpatient	Hospital admission to hospital discharge (post-surgery up to 3-mo)
Secondary	Readmission and reoperation rate	Related to Mesh device and/or Mesh Augmented Reinforcement procedure.	From the surgery to the 36-month visit