Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Sur… (NCT06547138) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Spain110 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses a silver-coated mesh called OPTILENE® SILVER MESH ELASTIC placed during abdominal aortic aneurysm or obesity-related surgery to try to prevent wound infections and hernias — is this something that might be relevant to my upcoming procedure, and what are your thoughts on whether it could benefit me?
2Since this is listed as a pilot study that hasn't started recruiting yet, how confident are you that the safety profile of this silver mesh is well enough understood for us to consider it, and what risks should I know about before thinking further?
3The trial is primarily measuring a specific type of surgical site infection called SSI A2/A3 — can you explain what that classification means and why that particular outcome matters for someone in my situation?
4Because this study hasn't started yet, do you think it would be worth waiting to see if it opens at a site near us, or would it be better to move forward now with standard approaches to infection and hernia prevention?
5For patients like me who are at higher risk of surgical site infections or incisional hernias, what options are already available outside of this trial, and how do they compare to what this mesh is trying to achieve?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.