ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention

Study Overview
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Brief Summary
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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.

Detailed Description
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The primary objective of this investigation is to confirm the efficacy of ProGrip™ Self-gripping Polyester Mesh to reduce the incidence of incisional hernia within 24 months post-operatively in subjects undergoing procedures with midline laparotomies. Secondary Objective The secondary objective of this investigation is to confirm the safety of ProGrip™ Self-gripping Polyester Mesh through the occurrence of adverse device effects or procedure related adverse events following the use of ProGrip™ Self- gripping Polyester Mesh in subjects undergoing procedures with midline laparotomies.

Official Title
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Poetry Study - ProGrip™ Self-gripping Polyester Mesh Prospective Embedded REgisTRY for Abdominal Wall Sutureline Reinforcement in Subjects Undergoing Midline Laparotomy to Prevent Incisional Hernia

Conditions
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Incisional Hernia

Intervention / Treatment
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* Device: Mesh augmented reinforcement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided informed consent. Subject is ≥ 18 years of age at the time of consent. Subject will be undergoing an elective midline laparotomy. 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: 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 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: Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death. Subject for which the device is used outside the product IFU, including; Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period 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 Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV). Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia. Investigator determined that a planned future surgery would interfere with application of mesh reinforcement. Subject has participated in an investigational drug or device research study within 30 days of enrollment. Subject has a life expectancy of <2 years. Subject has an ASA Physical Status Classification System score >3. Subject has >5 total risk factors or >2 high-risk factors

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hernia prevention cohort<br>single arm safety study, no control arm | Device: Mesh augmented reinforcement<br>* Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia rate | Occurence of incisional hernia assessed by clinical examination and abdominal CT scan | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | Adverse event incidence reported by number, severity, and relationship to the procedure and device | From the surgery to the 24-month visit | 
| Time to incisional hernia occurrence | Time to incisional hernia occurrence | From the surgery to the 24-month visit | 
| Post-operative pain at the site of surgery with Visual Analog Scale (VAS) | 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. | Day 0, Day 1, Day 8, Month 1, Month 12, Month 24 | 
| Quality of life questionnaire (QOL) for patient | 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. | Month 12, Month 24 | 
| Quality of life questionnaire (QOL) for patient | 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. | Month 1 | 
| Surgeon satisfaction | Surgeon satisfaction on mesh ease of use and manipulability will be collected in the Club Hernie registry database. | Day 0 |