Estudio piloto sobre la eficacia y seguridad de OPTILENE® SILVER MESH ELASTIC en la prevención de la infección del sitio quirúrgico (SSI) y la hernia incisional (IH) (SSIHLVER)
Estudio piloto multicéntrico descriptivo prospectivo sobre la eficacia y seguridad de la malla elástica de plata Optilene® en la prevención de la infección del sitio quirúrgico (SSI) y la hernia incisional (IH)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Irene Fita Esteban
- Número de teléfono: +34609054401
- Correo electrónico: info@bbraun.com
Copia de seguridad de contactos de estudio
- Nombre: José Manuel Molina Villar
- Número de teléfono: +34697502623
- Correo electrónico: info@bbraun.com
Ubicaciones de estudio
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Badalona, España, 08916
- Hospital Universitari Germans Tries i Pujol
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Contacto:
- Joan Francesc Julián, Dr.
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Investigador principal:
- Joan Francesc Julián, Dr.
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Badalona, España
- Hospital Municipal Badalona
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Contacto:
- Jorge Marroquin, Dr.
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Investigador principal:
- Jorge Marroquin, Dr.
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Calella, España, 08370
- Hospital Comarcal Sant Jaume de Calella
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Contacto:
- Paqui Vasco, Dr.
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Investigador principal:
- Paqui Vasco, Dr.
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Mataró, España, 08304
- Hospital de Mataró
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Contacto:
- Berhanu Chimdi, Dr.
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Investigador principal:
- Berhanu Chimdi, Dr.
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Santa Coloma de Gramenet, España, 08923
- Hospital Fundació Esperit Sant
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Contacto:
- Daniel Troyano Escribano, Dr.
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Investigador principal:
- Daniel Troyano Escribano, Dr.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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:
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Vascular surgery
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Colon and rectum
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Hepatobiliary
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Gastrointestinal
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Gynecology
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Urology
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Abdominal Aortic Aneurysm (AAA) repair
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Right hemicolectomy
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Left hemicolectomy
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Sigmoidectomy
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Anterior resection
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Abdominoperineal amputation
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Exploratory laparotomy
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Cholecystectomy
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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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Optilene® Silver Mesh Elastic
Prophylactic mesh in high-risk patients |
Prevention of incisional hernia after a prophylactic mesh in high-risk patients |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Surgical Site Infection (SSI) A2/A3 rate
Periodo de tiempo: at 6 months follow-up
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cumulative rate of of postoperative complications during the study period
Periodo de tiempo: at discharge (up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up
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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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Cumulative Surgical Site Infection (SSI) A2/A3 rate during the study period
Periodo de tiempo: at 1 month, 1 year and 2 year follow-up.
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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.
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Incisional hernia (IH) rate during the study period
Periodo de tiempo: repeatedly at 6 months, 1 year and 2 year follow-up.
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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.
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Length of hospital stay
Periodo de tiempo: at discharge (approximately up to 10 days after surgery)
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Number of days the patient has to stay in hospital after the surgery |
at discharge (approximately up to 10 days after surgery)
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Development of Pain: Visual Analogue Scale (VAS)
Periodo de tiempo: at discharge (approximately up to 10 days after surgery), 1 month, 6 months, 1 year and 2 year follow-up, using the VAS score
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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
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Time to return to work
Periodo de tiempo: at all postoperative examinations with a single value for each individual patient
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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
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Handling of the Optilene® Silver Mesh Elastic
Periodo de tiempo: intraoperatively
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Daniel Troyano Escribano, Dr., Fundació Hospital de l'Esperit Sant
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Exceso de peso
- Enfermedades aórticas
- Obesidad
- Aneurisma
- Aneurisma aortico
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Obesidad Mórbida
- Aneurisma Aórtico Abdominal
Otros números de identificación del estudio
- AAG-G-H-2126
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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