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Silver shield: new mesh aims to stop infections and hernias after emergency surgery

NCT ID NCT06547138

Prevention Sponsor: Aesculap AG 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special silver-coated mesh placed during emergency abdominal surgery to see if it can prevent surgical site infections and incisional hernias. About 110 adults having urgent open abdominal surgery will take part. Researchers will track infection and hernia rates for 6 months after surgery.

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.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

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.

Who is studied

High-risk patients according to the professional criteria (such as but not limited to: age, nutrition, body mass index, comorbidities, etc.) who are undergoing prophylactic mesh implantation to avoid surgical site infection after an emergency or urgent intra-abdominal laparotomy.

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: * Adult patients (18 years or older) * Surgical procedure requiring urgent, primary median laparotomy, which are classified as "Class III/Contaminated" or "Class IV/Dirty-Infected" regarding the CDC classification. These include but are not limited to: * Vascular surgery * Colon and rectum * Hepatobiliary * Gastrointestinal * Gynecology * Urology * Abdominal Aortic Aneurysm (AAA) repair * Right hemicolectomy * Left hemicolectomy * Sigmoidectomy * Anterior resection * Abdominoperineal amputation * Exploratory laparotomy * Cholecystectomy * Cholecystectomy and choledocotomy * Written informed consent Exclusion Criteria: * Pregnancy * Breast feeding * Patients \< 18 years old or patients who are still in the growth phase * Contaminated and infected areas * Hypersensitivity to silver * Direct contact with the viscera * Previous allergic reactions to components of the device * Patient with previous laparotomy * Transverse laparotomy * Patients with previous hernia repair * Simultaneous participation in another investigational clinical trial (drug or medical studies) * Patients with active oncologic treatment (chemo and radiotherapy) * Underlying autoimmune disease * Recent cardiovascular complication * Gynecology surgery * Urology surgery * Vascular surgery

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm morbid obesity

As listed by the trial registrant

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

Abdominal aortic aneurysm Morbid obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Hospital Comarcal Sant Jaume de Calella

    Calella, 08370, Spain

  • Hospital Fundació Esperit Sant

    Santa Coloma de Gramenet, 08923, Spain

  • Hospital Municipal Badalona

    Badalona, Spain

  • Hospital Universitari Germans Tries i Pujol

    Badalona, 08916, Spain

  • Hospital de Mataró

    Mataró, 08304, Spain

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