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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optilene® Silver Mesh Elastic | Prophylactic mesh in high-risk patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic mesh | Device | Prevention of incisional hernia after a prophylactic mesh in high-risk patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Fita Esteban | Contact | +34609054401 | info@bbraun.com | |
| José Manuel Molina Villar | Contact | +34697502623 | info@bbraun.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Troyano Escribano, Dr. | Fundació Hospital de l'Esperit Sant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Tries i Pujol | Badalona | 08916 | Spain |
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| 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 |
| 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 |
|
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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