NCT06547138Not 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)
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)
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 110 (estimated)
- First submitted
- 7 Aug 2024
- Start date
- Sept 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- Aesculap AG
- Diseases
- Obesity
- NCT number
- NCT06547138
What you commit to
- Study type: Observational
- Planned participants: 110
- From Sept 2026 to the primary completion date, Oct 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Contaminated and infected areas
- Hypersensitivity to silver
- Underlying autoimmune disease
Age
- Patients \< 18 years old or patients who are still in the growth phase
Other
- Pregnancy
- Breast feeding
- Direct contact with the viscera
- Transverse laparotomy
- Recent cardiovascular complication
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Municipal Badalona Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Universitari Germans Tries i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Unknown status |
| Hospital Comarcal Sant Jaume de Calella Coordinator of this site? Confirm its status | Calella | Spain | Unknown status |
| Hospital de Mataró Coordinator of this site? Confirm its status | Mataró | Spain | Unknown status |
| Hospital Fundació Esperit Sant Coordinator of this site? Confirm its status | Santa Coloma de Gramenet | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.