Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prophylactic mesh.
- Who it may be relevant to
- Registry conditions: Abdominal Aortic Aneurysm, Morbid Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
Interventions
- Device Prophylactic mesh
Prevention of incisional hernia after a prophylactic mesh in high-risk patients
Primary outcome measures
- Surgical Site Infection (SSI) A2/A3 rate [Time frame: at 6 months follow-up]
Secondary outcome measures (7)
- Cumulative rate of of postoperative complications during the study period [Time frame: at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up]
- Cumulative Surgical Site Infection (SSI) A2/A3 rate during the study period [Time frame: at 1 month, 1 year and 2 year follow-up.]
- Incisional hernia (IH) rate during the study period [Time frame: repeatedly at 6 months, 1 year and 2 year follow-up.]
- Length of hospital stay [Time frame: at discharge (approximately up to 10 days after surgery)]
- Development of Pain: Visual Analogue Scale (VAS) [Time frame: at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score]
- Time to return to work [Time frame: at all postoperative examinations with a single value for each individual patient]
- Handling of the Optilene® Silver Mesh Elastic [Time frame: intraoperatively]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 5 centers
- Hospital Universitari Germans Tries i Pujol — Badalona
- Hospital Municipal Badalona — Badalona
- Hospital Comarcal Sant Jaume de Calella — Calella
- Hospital de Mataró — Mataró
- Hospital Fundació Esperit Sant — Santa Coloma de Gramenet
Identifiers
NCT: NCT06547138 · AAG-G-H-2126