Abdominal Aortic Aneurysm, Morbid Obesity
Conditions
Keywords
urgent, primary median laparotomy
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.
Interventions
DEVICEProphylactic mesh
Prevention of incisional hernia after a prophylactic mesh in high-risk patients
Sponsors
Aesculap AG
B.Braun Surgical SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
| 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". |
| 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 |
| 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) |
Countries
Spain
Contacts
CONTACTIrene Fita Esteban
CONTACTJosé Manuel Molina Villar
PRINCIPAL_INVESTIGATORDaniel Troyano Escribano, Dr.
Fundació Hospital de l'Esperit Sant
Outcome results
None listed