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

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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

Trial contacts and locations

5

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Central trial contact

Marta Valor Soteras; Ricard Rosique

Data sourced from clinicaltrials.gov

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