Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
- Conditions
- Morbid ObesityAbdominal Aortic Aneurysm
- Interventions
- Device: Prophylactic mesh
- Registration Number
- NCT06547138
- Lead Sponsor
- Aesculap AG
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Optilene® Silver Mesh Elastic Prophylactic mesh Prophylactic mesh in high-risk patients
- Primary Outcome Measures
Name Time Method Surgical Site Infection (SSI) A2/A3 rate at 6 months follow-up SSIs remain a significant clinical problem as they are associated with substantial mortality and morbidity and impose severe demands on healthcare resources. Centers for Disease Control and Prevention Surgical Site Infection (SSI) Classification System differentiates Superficial SSI (A1), Deep Incisional SSI (A2) and Infection with involvement of organs/body cavities (A3). Only cases of A2 and A3 are considered for the Primary Outcome and are compared to rates from reference literature
- Secondary Outcome Measures
Name Time Method Cumulative Surgical Site Infection (SSI) A2/A3 rate during the study period at 1 month, 1 year and 2 year follow-up. Number of the Surgical Site Infection (SSI) (only A2 and A3) rate at every follow-up
Handling of the Optilene® Silver Mesh Elastic intraoperatively The handling will be evaluated using a questionnaire (Likert-type scale) with the dimensions Tensile Strength, Absence of memory effect, Elasticity, Stiffness, Surface weight, Thickness, Ease of being fixed with suture, Ease of package extraction as well as an overall opinion in five evaluation levels (excellent=1, very good=2, good=3, satisfied=4, poor=5)
Length of hospital stay at discharge (approximately up to 10 days after surgery) Number of days the patient has to stay in hospital after the surgery
Time to return to work at all postoperative examinations with a single value for each individual patient The number of days needed to return to work after the surgery of the individual patient is documented
Incisional hernia (IH) rate during the study period repeatedly at 6 months, 1 year and 2 year follow-up. Incisional hernia (IH) is a protrusion of tissue that forms at the site of a healing surgical scar. Incisional hernia refers to abdominal wall hernia at the site of a previous surgical incision.
Cumulative rate of of postoperative complications during the study period at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up Numbers of all postoperative complications such as mortality, burst abdomen, bowel obstruction, bulging, necrosis, fistula, wound dehiscence, hematoma, seroma, peritonitis are added to the overall complication rate that is observed over the postoperative course
Development of Pain: Visual Analogue Scale (VAS) at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".
Trial Locations
- Locations (5)
Hospital Universitari Germans Tries i Pujol
🇪🇸Badalona, Spain
Hospital Municipal Badalona
🇪🇸Badalona, Spain
Hospital Comarcal Sant Jaume de Calella
🇪🇸Calella, Spain
Hospital de Mataró
🇪🇸Mataró, Spain
Hospital Fundació Esperit Sant
🇪🇸Santa Coloma De Gramenet, Spain