Status:
ACTIVE_NOT_RECRUITING
Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence
Lead Sponsor:
Medtronic - MITG
Conditions:
Incisional Hernia
Incisional Hernia of Midline of Abdomen
Eligibility:
All Genders
18+ years
Phase:
NA
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 u...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2028
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT05424484
Start Date
November 22 2022
End Date
September 1 2028
Last Update
November 19 2025
Active Locations (13)
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1
Clinical Hospital Center Sisters of Mercy
Zagreb, Croatia, 10000
2
University Hospital Center of Zagreb
Zagreb, Croatia, 10000
3
Klinikum Braunschweig
Braunschweig, Germany, 38118
4
Pius-Hospital Medical Campus University of Oldenburg
Oldenburg, Germany, 26121