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

Aesculap

Status: Not yet enrolling

Conditions: Abdominal Aortic Aneurysm; Morbid Obesity

Treatments: Device: Prophylactic mesh

Study type: Observational

Funder types: Industry

Identifiers

NCT06547138

AAG-G-H-2126

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 1 patient group

Optilene® Silver Mesh Elastic

Description:

Prophylactic mesh in high-risk patients

Treatment:

Device: Prophylactic mesh