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New mesh may reduce infections in complex hernia surgery

NCT ID NCT01594450

Disease control Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 whether using a biological mesh (made from human or animal tissue) during surgery for infected ventral hernias leads to fewer wound problems than standard wound care alone. About 110 adults with infected hernias were randomly assigned to receive either the mesh or standard treatment. Researchers tracked infections, hernia recurrence, pain, and quality of life for up to three years.

What this could mean

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

Active substance
biological mesh (acellular dermal matrix)
What this could lead to
If successful, using a biological mesh could lower infection and hernia recurrence rates after surgery for infected ventral hernias.
What could go wrong
This is a completed Phase 3 trial with 110 participants, so results are available but may not apply to all hernia types. Biological meshes are expensive and may not outperform standard care.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

110 people

The number who actually took part.

Started

May 2012

Finished

Mar 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * wound infection related to a synthetic non-absorbable mesh for at least 15 days duration * incisional abdominal hernia with an abcess or fistula, without the presence of a synthetic non-absorbable mesh * incisional abdominal hernias smaller than 20 centimeter in the 2 largest diameters * incisional abdominal hernias requiring a surgical procedure * incisional abdominal hernias amenable to repair with a single biological mesh * age over 18 years Exclusion Criteria: * non-infected incisional abdominal hernia * history of biological mesh placement * incisional abdominal hernia in contaminated, but non infected field (stoma presence, violation of gastrointestinal tract) * incisional abdominal hernia larger than 20 x 20 cm * BMI ≥ 40 kg/m2 * ASA score 4 and 5 * immunosuppression (including steroid and cytotoxic therapy) * chronic disease such as cirrhosis, renal insufficiency with renal dialysis, malignant disease, known collagen disorder * life expectancy under than 36 months * allergy to one of the biological mesh components * pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

Hernia, Ventral

As listed by the trial registrant

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

Ventral hernia

Contacts and locations

Locations

  • Claude Huriez Hospital, University hospital

    Lille, 59037, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.