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Mesh may prevent hernias after surgery, but trial cut short

NCT ID NCT03912662

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a special mesh placed during abdominal surgery to prevent incisional hernias, which can occur in 10-50% of patients. The trial enrolled 32 adults undergoing elective midline laparotomy and tracked hernia development for 24 months using CT scans and exams. However, the study was terminated early, limiting what can be concluded.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ProGrip self-gripping polyester mesh
What this could lead to
If successful, this mesh could reduce the risk of incisional hernias after abdominal surgery, lowering the need for additional operations.
What could go wrong
The trial was terminated early with only 32 participants, so results are limited. The mesh may not work for everyone and carries risks like infection or pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

32 people

The number who actually took part.

Started

Sep 2019

Finished

Sep 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Incisional Hernia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHU Besançon

    Besançon, France

  • CHU Hopitaux de Rouen

    Rouen, France

  • CHU Lille

    Lille, France

  • CHU Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67000, France

  • CHU de Bordeaux

    Bordeaux, 33076, France

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    Bordeaux, France

  • CHU de Nantes

    Nantes, 44000, France

  • CHU de Nîmes

    Nîmes, 30029, France

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, 35033, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310, France

  • HCL Louis Pradel

    Lyon, France

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