- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01629030
Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
Descripción general del estudio
Estado
Descripción detallada
Deep sternal wound infection after coronary artery bypass graft is a very dangerous complication as it prolongs hospital stay, increase morbidity and mortality, and increase cost of care.
As a risk factor of surgical site infection, risk index reported by NNIS (national nosocomial infection surveillance), Euroscore, or Society of thoracic surgeon risk score are currently used. However, as various performances are reported regarding these index or scoring systems, and many factors are needed for these index or scoring system, there is a need to develop a more simple risk factor with better performance. We focused on the differential blood cell count, as the neutrophil and lymphocyte count are related to the degree of surgical invasion, and inflammatory response. Previous studies reported that the neutrophilia or lymphopenia is related to postoperative infection. Therefore, we are trying to evaluate the performance of preoperative or postoperative the blood cell differential count as a risk factor for sternal wound infection after coronary artery bypass surgery.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Seoul, Corea, república de, 135-710
- Reclutamiento
- Samsung Medical Center
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Sub-Investigador:
- Sangmin M. Lee, MD, PhD
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Sub-Investigador:
- Young Tak Lee, MD, PhD
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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
Descripción
Inclusion Criteria:
- Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.
Exclusion Criteria:
- Those underwent coronary artery bypass graft surgery with mini-thoracotomy
- Those with insufficient study data recognized by electronic medical record
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Coronary Artery Bypass Graft Group
Those underwent coronary artery bypass graft surgery with median sternotomy in Samsung Medical Center during the period of January 2008 and December 2011.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
postoperative surgical wound infection
Periodo de tiempo: within first week after the end of coronary artery bypass graft surgery
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postoperative surgical wound infection within first week after the end of coronary artery bypass graft surgery, classified as a superfical or deep sternal wound infection
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within first week after the end of coronary artery bypass graft surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
preoperative total leukocyte count
Periodo de tiempo: 1 day before surgery
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preoperative total leukocyte count
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1 day before surgery
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preoperative neutrophil count
Periodo de tiempo: 1 day before surgery
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preoperative neutrophil count
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1 day before surgery
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preoperative lymphocyte count
Periodo de tiempo: 1 day before surgery
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preoperative lymphocyte count
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1 day before surgery
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postoperative total leukocyte count
Periodo de tiempo: 2 hour after the end of surgery
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postoprative total leukocyte count
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2 hour after the end of surgery
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postoperative neutrophil count
Periodo de tiempo: 2 hour after the end of surgery
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postoperative neutrophil count
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2 hour after the end of surgery
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postoperative lymphocyte count
Periodo de tiempo: 2 hour after the end of surgery
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postoperative lymphocyte count
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2 hour after the end of surgery
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preoperative NNIS risk index
Periodo de tiempo: 1 day before surgery
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preoperative NNIS risk index
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1 day before surgery
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preoperative EuroScore
Periodo de tiempo: 1 day before surgery
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preoperative EuroScore
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1 day before surgery
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Preoperative STS
Periodo de tiempo: 1 day before surgery
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Preoperative STS (Society of Thoracic Surgeons risk score)
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1 day before surgery
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the incidence of surgical reopen with surgical wound infection
Periodo de tiempo: within 1 month after surgery
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the incidence of surgical reopen with surgical wound infection
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within 1 month after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Won Ho Kim, MD, PhD, Samsung Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2012-05-067-001
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