Study Evaluating Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery (EURIDICE)
9 de mayo de 2012 actualizado por: Pfizer
A Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
This is an observational study to evaluate the relative importance of the known risk factors for severe surgical site infections (SSIs) on the development of the more severe SSI cases, and to describe the demographic, clinical features, etiology and the management and outcome of patients suffering from severe SSIs in Spain.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Case and Control study.
Tipo de estudio
De observación
Inscripción (Actual)
180
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Patients with or without surgical site infections (SSI) after surgery, treated in major hospitals with general surgical units selected from all over Spain
Descripción
Inclusion Criteria:
- Age of or above 18 years.
- Admitted to a General Surgery Ward for elective or emergency abdominal surgery.
- Contaminated or dirty-infected surgical procedures.
- Only for cases, they will have to present symptoms and signs of a surgical site infection (SSI) (within 0-30 days) after abdominal surgery.
- Only for controls, patients must be free of SSI after 30 days from surgery, regardless of whether they are still in the hospital or being observed as an outpatient in the external clinic.
Exclusion Criteria:
- Age under 18 years.
- American Society of Anesthesiologist (ASA) score of 5 or above.
- Surgical implant in place.
- Clean or clean-contaminated surgical procedures.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Case
Cases will be defined as patients with elective or emergency abdominal surgery who develop severe surgical site infection (deep incisional or organ cavity type; see Center for Disease Control (CDC) criteria for definition in the Appendix), within 0-30 days of surgery.
|
Clinical record review.
Clinical record review
|
|
Control
Surgeon-matched controls will be patients with elective or emergency abdominal surgery who are free of surgical site infection (SSI) after 30 days from the surgery.
|
Clinical record review.
Clinical record review
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants With Pre-surgical Morbidities
Periodo de tiempo: Baseline (Pre-surgical)
|
Morbidities (risk factors) included: neoplasm, tobacco use, body mass index (weight in kilograms divided by height in meters squared [BMI kg/m2]) greater than (>) 30, diabetes mellitus (DM), immunosuppression/ corticosteroids, anemia (hemoglobin [Hb] less than (>) 9 grams per deciliter [gr/dL]) or malnutrition (hypoalbuminemia).
|
Baseline (Pre-surgical)
|
|
Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis
Periodo de tiempo: Baseline (Pre-surgical)
|
Baseline (Pre-surgical)
|
|
|
Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery
Periodo de tiempo: Day 0 (day of surgery)
|
Day 0 (day of surgery)
|
|
|
Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty
Periodo de tiempo: Day 0 (day of surgery)
|
Surgical infection risk class: Clean-contaminated: controlled entry in normally colonized body cavities/no unusual contamination/minimum fluid discharge/minimal sterile technique violation/re-surgery on clean surgical incision within 7 days/negative surgical exploration through intact skin.
Contaminated: no acute inflammation/purulent discharge/significant fluid/material violation of sterile technique/penetrating trauma less than 4 hours old/graft in chronic skin wounds.
Dirty: pus-abscess drainage/ preoperatively colonized body cavity perforated/penetrating trauma more than 4 hours old.
|
Day 0 (day of surgery)
|
|
Type of Surgeon
Periodo de tiempo: Day 0 (day of surgery)
|
Surgical speciality of physician who performed surgery.
|
Day 0 (day of surgery)
|
|
Percentage of Participants With Infection
Periodo de tiempo: Day 0 (day of surgery) up to 30 days post surgery
|
Microorganism infection by bacterial type.
|
Day 0 (day of surgery) up to 30 days post surgery
|
|
Percentage of Participants Who Showed Clinical Improvement of SSI
Periodo de tiempo: Day 0 (day of surgery) up to 30 days post surgery
|
Clinical improvement of SSI was defined as healed (signs and symptoms of initial infection resolved) or improved (initial signs and symptoms significantly diminished without the appearance of new signs).
|
Day 0 (day of surgery) up to 30 days post surgery
|
|
Percentage of Participants With Post-surgical Drainage
Periodo de tiempo: Day 0 (day of surgery) up to 30 days post surgery
|
Day 0 (day of surgery) up to 30 days post surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0
Periodo de tiempo: Baseline (pre-surgical)
|
Percentage of participants with NNISS score for increased preoperative risk of infection.
|
Baseline (pre-surgical)
|
|
ASEPSIS Classification in Participants With Serious SSI
Periodo de tiempo: Up to 30 days post surgery
|
Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissue, Isolation of bacteria, Stay in hospital prolonged over 14 days (ASEPSIS).
ASEPSIS classification is a numerical indication of wound healing progress: satisfactory healing (0-10), disturbance of healing (11-20), minor wound infection (20-30), moderate wound infection (30-40), and severe wound infection (over 40).
|
Up to 30 days post surgery
|
|
Classification of SSI Infection
Periodo de tiempo: Day 0 (day of surgery) up to 30 days post surgery
|
Participants with organ-space or deep incisional SSI.
|
Day 0 (day of surgery) up to 30 days post surgery
|
|
Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)
Periodo de tiempo: Day 0 (day of surgery) up to 30 days post surgery
|
Resolution of SSI ranged from eradication (infection cured) to persistence (infection continued).
|
Day 0 (day of surgery) up to 30 days post surgery
|
|
Number of Participants With Antimicrobial Resistance
Periodo de tiempo: Day 0 (day of surgery) up to 30 days post surgery
|
Microbiological resistance reported for microorganisms that were found at a frequency greater (>) than 5 percent (%).
|
Day 0 (day of surgery) up to 30 days post surgery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2009
Finalización primaria (Actual)
1 de noviembre de 2010
Finalización del estudio (Actual)
1 de noviembre de 2010
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2009
Primero enviado que cumplió con los criterios de control de calidad
20 de mayo de 2009
Publicado por primera vez (Estimar)
21 de mayo de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
15 de mayo de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
9 de mayo de 2012
Última verificación
1 de mayo de 2012
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B1811046
- 3074A1-4463 (Otro identificador: Wyeth)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Elective or emergency abdominal surgery
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Prim PD Dr Afshin AssadianWilhelminenspital ViennaDesconocidoEnfermedades arteriales oclusivas | Aneurisma Aórtico AbdominalAustria