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.
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.
Vascular surgery
Colon and rectum
Pregnancy
Breast feeding
Patients < 18 years old or patients who are still in the growth phase
Contaminated and infected areas
High-risk patients according to the professional criteria (such as but not limited to: age, nutrition, body mass index, comorbidities, etc.) who are undergoing prophylactic mesh implantation to avoid surgical site infection after an emergency or urgent intra-abdominal laparotomy.
Cohort
Prospective
Prophylactic mesh
DevicePrevention of incisional hernia after a prophylactic mesh in high-risk patients
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
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
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
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.
Length of hospital stay
Number of days the patient has to stay in hospital after the surgery
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Aesculap AG
Lead sponsor
B.Braun Surgical SA
Collaborator
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