Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
NCT Number: NCT06547138
Acronym: SSIHLVER
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Abdominal Aortic Aneurysm|Morbid Obesity
Interventions: DEVICE: Prophylactic mesh
Sponsor: Aesculap AG
Collaborators: B.Braun Surgical SA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Observational Model: |Time Perspective: p
Start Date: 2025-05
Completion Date: 2027-05
Locations: Hospital Universitari Germans Tries i Pujol, Badalona, 08916, Spain|Hospital Municipal Badalona, Badalona, Spain|Hospital Comarcal Sant Jaume de Calella, Calella, 08370, Spain|Hospital de Mataró, Mataró, 08304, Spain|Hospital Fundació Esperit Sant, Santa Coloma De Gramenet, 08923, Spain

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.

Primary Outcome Measures: Surgical Site Infection (SSI) A2/A3 rate, 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, at 6 months follow-up
Secondary Outcome Measures: Cumulative rate of of postoperative complications during the study period, 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, 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, Number of the Surgical Site Infection (SSI) (only A2 and A3) rate at every follow-up, at 1 month, 1 year and 2 year follow-up.|Incisional hernia (IH) rate during the study period, 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., repeatedly at 6 months, 1 year and 2 year follow-up.|Length of hospital stay, Number of days the patient has to stay in hospital after the surgery, at discharge (approximately up to 10 days after surgery)|Development of Pain: Visual Analogue Scale (VAS), 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"., 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, The number of days needed to return to work after the surgery of the individual patient is documented, at all postoperative examinations with a single value for each individual patient|Handling of the Optilene® Silver Mesh Elastic, 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), intraoperatively