Status:
NOT_YET_RECRUITING
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Abdominal Aortic Aneurysm
Morbid Obesity
Eligibility:
All Genders
18+ years
Brief 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 ...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06547138
Start Date
March 1 2026
End Date
December 1 2029
Last Update
August 28 2025
Active Locations (5)
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1
Hospital Universitari Germans Tries i Pujol
Badalona, Spain, 08916
2
Hospital Municipal Badalona
Badalona, Spain
3
Hospital Comarcal Sant Jaume de Calella
Calella, Spain, 08370
4
Hospital de Mataró
Mataró, Spain, 08304