Clinical trial NCT03912662: ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention
Official title: 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: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Incisional Hernia
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2019-04-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incisional hernia rate
timeFrame: 24 months
Secondary outcomes:
measure: Adverse event
timeFrame: From the surgery to the 24-month visit
measure: Time to incisional hernia occurrence
timeFrame: From the surgery to the 24-month visit
measure: Post-operative pain at the site of surgery with Visual Analog Scale (VAS)
timeFrame: Day 0, Day 1, Day 8, Month 1, Month 12, Month 24
measure: Quality of life questionnaire (QOL) for patient
timeFrame: Month 12, Month 24
measure: Quality of life questionnaire (QOL) for patient
timeFrame: Month 1
measure: Surgeon satisfaction
timeFrame: Day 0
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Haut-Lévêque
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: HCL Louis Pradel
city: Nantes
country: France
facility: CHU de Nantes
city: Nîmes
country: France
facility: CHU de Nîmes
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Pontchaillou
city: Rouen
country: France
facility: CHU Hopitaux de Rouen
city: Strasbourg
country: France
facility: CHU Strasbourg - Nouvel Hôpital Civil
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Martin Bertrand, MD
role: PRINCIPAL_INVESTIGATOR
References: