An interventional study of Self-Gripping Resorbable Mesh in Incisional Hernia, Incisional Hernia of Midline of Abdomen and Midline Laparotomy, sponsored by Medtronic - MITG. Active, not recruiting at 13 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Medtronic - MITG · Not applicable, Interventional, and Prevention
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 and European post-market clinical follow-up needs (PMCF). 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 60 months postoperatively.
219 studies on the registry are indexed under Incisional Hernia; 48 are open to participants now.
This study's enrollment of 123 is above the median of 108 across 137 interventional studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →Medtronic - MITG is the lead sponsor of 176 studies on the registry; 5 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
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Inclusion Criteria:
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 with current chemo and/or radiation therapy within 2 weeks of procedure
Only exclusion of chemotherapeutic drugs that have:
Intraoperative Exclusion criteria
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
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 60-month visit
Time to other adverse device effects (ADE)
Time from skin incision to ADE
Time frame: From the surgery to the 60-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-, 36-, 48- and 60- 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-, 36-, 48- and 60- 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 60-month visit
Incisional Hernia Rate
Occurrence of incisional hernia when suspected during phone call follow-up visits and subsequently assessed by clinical examination and abdominal ultrasound exam
Time frame: 48- and 60-months
Incisional Hernia Rate
Occurrence of incisional hernia when suspected during phone call follow-up visits and subsequently assessed by clinical examination
Time frame: 48- and 60-months
Incisional Hernia Rate
Occurrence of incisional hernia reported by subjects through the "modified " PROMID questionnaire administered at phone call follow-up visits
Time frame: 48- and 60-months
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Medtronic - MITG