Do Closed Suction Drains Affect the Complications Rate of Breast Reconstruction With Silicone Prosthesis?
Complications of Breast Reconstruction With Silicone Prosthesis in Relation to Closed Suction Drains
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Breast reconstruction with silicone prosthesis can be divided into two groups: immediate and late reconstructions. The complications rates reported in the literature are around 30% for delayed reconstructions and 50% for immediate reconstructions. The estimated surgical site infection rate is approximately 7% and seroma formation rate is approximately 1.2%.
In many of the procedures closed suction drains are left for fluid drainage, in order to reduce seroma formation. Still, the timing of drains' removal is controversial. Our aim in this study is to describe the relation between the placement of closed suction drains, the timing for their removal, and immediate post operative complications.
Patients that underwent breast reconstruction with silicone prosthesis and in which drains will be left in the surgical field would be randomly assigned into two groups: a control group, in which drains will be removed when the daily discharge will be below 20 cc for two consecutive days and the study group, in which drains will be removed on post operative day (POD) 10. All patients will receive the same antibiotic prophylaxis regimen. Cultures will be taken from fluid discharge POD 4,8,10 and 12. The incidence of local wound complications such as infection, seroma, hematoma and skin necrosis was record and analyzed.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
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:
- patients that underwent immediate or late breast reconstruction with silicone prosthesis (expanders/implants)and in which closed suction drains were left in the operating field according to the decision of the operating surgeon.
- signature of informed consent form
Exclusion Criteria:
- age under 18
- breast reconstruction without prosthesis
- Breast reconstruction without the use of drains
- Active infection during time of surgery in surgical site
- Coagulation disease
- Psychiatric illness
- Immune disease
- Lack of communication or language problems
- Foreign residents, not Israeli citizens
- Prisoners
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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control
drains would be removed when daily discharge will be below 20 cc for 2 consecutive days
|
Cultures will be taken from drain's fluids discharge in Post Operative Day 4,8,10,12.
When drain is removed cultures of the drain tip are taken.
Clinical signs of surgical signs infections will be observed.
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|
study
drains will be removed on post operative day (POD) 10
|
Cultures will be taken from drain's fluids discharge in Post Operative Day 4,8,10,12.
When drain is removed cultures of the drain tip are taken.
Clinical signs of surgical signs infections will be observed.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Palabras clave
Otros números de identificación del estudio
- SHEBA -08-5530 -EW- CTIL
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