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