ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention

Overview

Interventional, prospective, multicenter, post-marketing clinical follow-up study. After midline laparotomy, the probability to develop an incisional hernia ranges from 10% to 50% depending on the complexity of the surgery and patient state of health. As the clinical data needed for the study corresponds with those collected by Club Hernie registry, the clinical study will use the established registry database to collect performance and safety data on the prevention of incisional hernias within 24 months post operatively.

Full Title of Study: “Poetry Study – ProGrip™ Self-gripping Polyester Mesh Prospective Embedded REgisTRY for Abdominal Wall Sutureline Reinforcement in Subjects Undergoing Midline Laparotomy to Prevent Incisional Hernia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2023

Interventions

  • Device: Mesh augmented reinforcement
    • Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh

Arms, Groups and Cohorts

  • Other: Hernia prevention cohort

Clinical Trial Outcome Measures

Primary Measures

  • Incisional hernia rate
    • Time Frame: 24 months
    • Occurence of incisional hernia assessed by clinical examination and abdominal CT scan

Secondary Measures

  • Adverse event
    • Time Frame: From the surgery to the 24-month visit
    • Adverse event incidence reported by number, severity, and relationship to the procedure and device
  • Time to incisional hernia occurrence
    • Time Frame: From the surgery to the 24-month visit
    • Time to incisional hernia occurrence
  • Post-operative pain at the site of surgery with Visual Analog Scale (VAS)
    • Time Frame: Day 0, Day 1, Day 8, Month 1, Month 12, Month 24
    • Assessment of post-operative pain using a 0 to 10 Visual Analogic Scale. Worst pain experienced over the last 24 hours. Mild pain for VAS score between 0 and 3. Moderate pain for VAS score >3 and ≤6. Severe pain for VAS score >6.
  • Quality of life questionnaire (QOL) for patient
    • Time Frame: Month 12, Month 24
    • Assessment with Club Hernie registry QOL questionnaire of patient treated for suture line mesh reinforcement for long follow-up. Two sets of self-administered QOL and patient satisfaction questionnaire will be administered by phone call at 12 and 24 months.
  • Quality of life questionnaire (QOL) for patient
    • Time Frame: Month 1
    • Assessment with Club Hernie registry QOL questionnaire of patient treated for suture line mesh reinforcement for long follow-up. A self-administered QOL questionnaire will be administered at 1 month.
  • Surgeon satisfaction
    • Time Frame: Day 0
    • Surgeon satisfaction on mesh ease of use and manipulability will be collected in the Club Hernie registry database.

Participating in This Clinical Trial

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 midline laparotomy. 4. Subject may have a combination of low- and high-risk factors but cannot exceed a total of 5 risk factors or have more than 2 high-risk factors. Subject must have at least 2 low-risk factors if subject does not have any high-risk factors. High- and low-risk factors include: 1. High-Risk Factors (maximum of 2): i.BMI≥ 35; ii.Prior open abdominal surgery; iii.Daily active smoker or Chronic Obstructive Pulmonary disease (COPD) diagnosis; iv. Current or recent (within 1 year) cancer diagnosis or chemotherapy treatment; v.History of or current abdominal aorta aneurism or surgery for abdominal aortaaneurism 2. Low-Risk Factors (minimum of 2, if no high-risk factors): i.25 ≤ BMI < 35; ii.Age > 45; iii.Uncontrolled diabetes; iv.Malnutrition as defined by 10% weight loss within the last 3 months; v.Current immunosuppressive treatment; vi.Undergoing colorectal surgery Exclusion Criteria:

1. Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death. 2. Subject for which the device is used outside the product IFU, including; 1. Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period 2. Subject who has an infection within 30 days of enrollment or, at the time of the surgery, has any active, acute or chronic infection(s) that are uncontrolled and/or requiring treatment such as antibiotics 3. Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV). 3. Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia. 4. Investigator determined that a planned future surgery would interfere with application of mesh reinforcement. 5. Subject has participated in an investigational drug or device research study within 30 days of enrollment. 6. Subject has a life expectancy of <2 years. 7. Subject has an ASA Physical Status Classification System score >3. 8. Subject has >5 total risk factors or >2 high-risk factors

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medtronic – MITG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michel Prudhomme, MD, Principal Investigator, Centre Hospitalier Universitaire de Nīmes
  • Overall Contact(s)
    • Katie Bayliss, 763.203.4538, katie.j.bayliss@medtronic.com

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