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

Launched by AESCULAP AG · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special medical device called Optilene® Silver Mesh Elastic to see if it can help prevent infections and hernias after certain urgent surgeries. The focus is on patients who need a type of surgery called median laparotomy, which is often necessary for conditions like abdominal aortic aneurysm or for patients with morbid obesity. The researchers will collect data over six months to see how effective this mesh is in reducing the rates of surgical site infections and incisional hernias.

To participate in the study, patients must be adults aged 18 or older and require an urgent median laparotomy surgery that is classified as contaminated or dirty. However, certain individuals cannot join the trial, including those who are pregnant, breastfeeding, or have specific medical conditions that could complicate their surgery. If you meet the eligibility criteria and choose to participate, you will be part of a process aimed at improving surgical outcomes for future patients. Please remember that the study is not yet recruiting, so it’s important to stay tuned for updates.

Gender

ALL

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