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).
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
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
123
Self-Gripping Resorbable Mesh used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II).
Clinical Hospital Center Sisters of Mercy
Zagreb, Croatia
University Hospital Center of Zagreb
Zagreb, Croatia
Klinikum Braunschweig
Braunschweig, Germany
Pius-Hospital Medical Campus University of Oldenburg
Oldenburg, Germany
Barmherzige Brüder Regensburg
Regensburg, Germany
IJsselland Ziekenhuis
Capelle aan den IJssel, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Consorci Sanitari de l'Anoia Hospital Universitari d'Igualada
Igualada, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
...and 3 more locations
Incisional Hernia Rate
Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam
Time frame: 12 months
Incisional Hernia Rate
Occurrence of incisional hernia assessed by clinical examination and abdominal ultrasound exam
Time frame: 24- and 36-months
Incisional Hernia Rate
Occurrence of incisional hernia assessed by clinical examination
Time frame: 3-, 6-, 12-, 24-, and 36- months
Time to Incisional Hernia
Time from surgery to incisional hernia
Time frame: From the surgery to the 36-month visit
Time to other adverse device effects (ADE)
Time from skin incision to ADE
Time frame: From the surgery to the 36-month visit
Incidence of all adverse device effects (ADEs)
Adverse device effects related to mesh and mesh-augmented reinforcement procedure
Time frame: Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months
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
Time frame: Intra-operatively, at discharge (post-surgery up to 3-mo), and within 3-, 6-, 12-, 24-, and 36- months
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
Time frame: baseline (screening), discharge (post-surgery up to 3-mo) and at 3-, 6-, 12-, 24-, and 36- months
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.
Time frame: Baseline and at 3-, 6-, 12-, 24-, and 36- months
Surgeon Satisfaction
Surgeon satisfaction questionnaire on mesh use
Time frame: Day 0, post-operative
Hospital length of stay
Amount of time spent inpatient
Time frame: Hospital admission to hospital discharge (post-surgery up to 3-mo)
Readmission and reoperation rate
Related to Mesh device and/or Mesh Augmented Reinforcement procedure.
Time frame: From the surgery to the 36-month visit
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