Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)

Starting soon

Conditions studied: Abdominal Aortic Aneurysm, Morbid Obesity

In brief

The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on the SSI rates, IH rates and overall clinical performance of Optilene® Silver Mesh Elastic used for the prevention of incisional hernia as prophylactic mesh in patients that require urgent median laparotomy in clinical routine.

Key facts

Study ID

NCT06547138

Run by

Aesculap AG

People needed

110

Starts

2026-09-01

Expected to finish

2028-09-01

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital Universitari Germans Tries i Pujol — Badalona, Spain
• Hospital Municipal Badalona — Badalona, Spain
• Hospital Comarcal Sant Jaume de Calella — Calella, Spain
• Hospital de Mataró — Mataró, Spain
• Hospital Fundació Esperit Sant — Santa Coloma de Gramenet, Spain

Full record on ClinicalTrials.gov

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