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

NCT06547138 · tracked via the Priya Life Science Spain tracker

Sponsor

Aesculap AG

Phase

Observational

Started

2026-09

Last updated

2026-06-02

Condition(s) studied

Abdominal Aortic AneurysmMorbid Obesity

Investigational drug(s) / intervention(s)

Prophylactic mesh

Prophylactic mesh: Prevention of incisional hernia after a prophylactic mesh in high-risk patients

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

Surgical Site Infection (SSI) A2/A3 rate — at 6 months follow-up
SSIs remain a significant clinical problem as they are associated with substantial mortality and morbidity and impose severe demands on healthcare resources. Centers for Disease Control and Prevention Surgical Site Infection (SSI) Classification System differentiates Superficial SSI (A1), Deep Incisional SSI (A2) and Infection with involvement of organs/body cavities (A3). Only cases of A2 and A3 are considered for the Primary Outcome and are compared to rates from reference literature

Trial sites (5)

Facility	City	Region
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06547138 on ClinicalTrials.gov ↗ ← All trials in Spain