Studies a silver mesh to prevent wound infection and hernia after belly surgery
Observes a silver mesh device used to prevent wound infection and hernia in adults.
Plain-language title generated from the registry record
Registry title: Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Key facts
- Where
- Badalona, Calella, Mataró, and Santa Coloma de Gramenet, SpainSee the 5 sites
Where in Spain
- Hospital Municipal BadalonaBadalona, SpainNo longer taking part
- Hospital Universitari Germans Tries i PujolBadalona, SpainNo longer taking part
- Hospital Comarcal Sant Jaume de CalellaCalella, SpainNo longer taking part
- Hospital de MataróMataró, SpainNo longer taking part
- Hospital Fundació Esperit SantSanta Coloma de Gramenet, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aesculap AG
- Trial code
- NCT06547138
- Record updated
- 6 November 2026
- Original description
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.Read full original descriptionShow less
Prospective Descriptive Multicentre Pilot Study On The Effectiveness and Safety Of Optilene® Silver Mesh Elastic In Prevention Of Surgical Site Infection (SSI) And Incisional Hernia (IH)
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.
Inclusion: 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: Previous allergic reactions to components of the device; Patient with previous 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); Gynecology surgery; Urology surgery; Vascular surgery; Contaminated and infected areas; Hypersensitivity to silver; Underlying autoimmune disease; Patients < 18 years old or patients who are still in the growth phase; Pregnancy; Breast feeding; Direct contact with the viscera; Transverse laparotomy; Recent cardiovascular complication.