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Not Yet Recruiting NCT06547138

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

Conditions: Abdominal Aortic Aneurysm, Morbid Obesity

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 110
Sponsor: Aesculap AG

Location: Hospital Universitari Germans Tries i Pujol Badalona

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 Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06547138). StuddyBuddy aggregates publicly available trial information.