ProGripTM Self-Gripping Polyester Mesh in Incisional Hernia Prevention

Incisional Hernia Clinical Trial

— POETRY  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03912662
• Other study ID #: MDT17048POETRY
• Status: Terminated
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: September 6, 2022

Study information

• Verified date: May 2023
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

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

Locations

Country	Name	City	State
France	CHU Besançon	Besançon
France	CHU de Bordeaux	Bordeaux
France	CHU de Bordeaux - Hôpital Haut-Lévêque	Bordeaux
France	CHU Lille	Lille
France	HCL Louis Pradel	Lyon
France	CHU de Nantes	Nantes
France	CHU de Nîmes	Nîmes
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	CHU de Rennes - Hôpital Pontchaillou	Rennes
France	CHU Hopitaux de Rouen	Rouen
France	CHU Strasbourg - Nouvel Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional hernia rate	Occurence of incisional hernia assessed by clinical examination and abdominal CT scan	24 months
Secondary	Adverse event	Adverse event incidence reported by number, severity, and relationship to the procedure and device	From the surgery to the 24-month visit
Secondary	Time to incisional hernia occurrence	Time to incisional hernia occurrence	From the surgery to the 24-month visit
Secondary	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
Secondary	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
Secondary	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
Secondary	Surgeon satisfaction	Surgeon satisfaction on mesh ease of use and manipulability will be collected in the Club Hernie registry database.	Day 0