Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
A Prospective Pilot Study of Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
This prospective single-arm pilot study will evaluate the application of meshed 5 × 7 cm Restrata® sheets to the abdominal wall donor site following deep inferior epigastric perforator (DIEP) or abdominal wall autologous free tissue transfer in 20 eligible patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Justin Sacks, MD, MBA, FACS
- Número de teléfono: 314-454-4894
- Correo electrónico: jmsacks@wustl.edu
Ubicaciones de estudio
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Contacto:
- Justin Sacks, MD, MBA, FACS
- Número de teléfono: 314-454-4894
- Correo electrónico: jmsacks@wustl.edu
-
Investigador principal:
- Justin Sacks, MD, MBA, FACS
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Sub-Investigador:
- William Zhu, MD
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Sub-Investigador:
- Terence Myckatyn, MD
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Sub-Investigador:
- Gary Skolnick, MBA
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Scheduled for DIEP or abdominal wall autologous free tissue transfer procedure.
- At least 18 years of age.
- Karnofsky performance status ≤ 80%
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria:
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Current smoker.
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Body mass index > 39.9.
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Received systemic chemotherapy within 4 weeks prior to the scheduled DIEP or abdominal wall autologous free tissue transfer procedure.
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Uncontrolled diabetes mellitus determined by the investigator.
*Note: if there is documentation of HgbA1c > 12% within 3 months of the scheduled DIEP or abdominal wall autologous free tissue transfer procedure, it will need to be reviewed by the PI to determine the patient's clinical situation and eligibility.
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Pregnant.
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Currently receiving any investigational agents.
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Known sensitivity to resorbable sutures (polyglactin 910, polydioxanone).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Restrata® application
Patients undergoing standard of care deep inferior epigastric perforator (DIEP) or abdominal wall free tissue transfer procedure will have Restrata® sheets applied to the abdominal wall donor site following flap harvest. Patients will be followed for 12 months to assess outcomes. |
Restrata® is prepared in 5 x 7cm sheets and will be administered to the abdominal wall donor site following the flab harvest.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of post-operative seroma, hematoma formation, or wound dehiscence within 6 weeks of procedure
Periodo de tiempo: At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)
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Clinical assessment of seroma formation will be conducted by the investigator through evaluation of the surgical site for the presence of swelling and/or fluid wave upon exam. Clinical assessment of hematoma formation and wound dehiscence will be conducted by the investigator through evaluation of the surgical site for the presence of swelling, discoloration, and firmness to the touch upon palpitation. Wound dehiscence is defined as separation of the margins of the closed surgical incision made in the skin, with or without exposure/protrusion of underlying tissue. |
At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of post-operative infection
Periodo de tiempo: At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
Post-operative infection will be assessed via the occurrence of physiological symptoms including fever, pain, swelling, erythema, or seroma via clinical assessment. Post-operative infection will be summarized as absolute counts and as descriptive proportions along with corresponding 95% confidence intervals. |
At time of procedure until 3 months after procedure (total estimated time: 3 months)
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|
Rate of post-operative wound dehiscence within 3 months of procedure
Periodo de tiempo: At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
Post-operative wound dehiscence will be determined via ultrasound and clinical assessment of the surgical site. Wound dehiscence is defined as separation of the margins of the closed surgical incision made in the skin, with or without exposure/protrusion of underlying tissue. Wound dehiscence will be summarized as absolute counts and as descriptive proportions along with corresponding 95% confidence intervals. |
At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
|
Rate of unplanned re-operation at the donor site
Periodo de tiempo: At time of procedure until 3 months after procedure (total estimated time: 3 months)
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Incidence of unplanned reoperation of the donor site from the initial surgical procedure will be assessed as they occur and reported as absolute counts and descriptive proportions along with corresponding 95% confidence intervals. |
At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
|
Drain output in cc
Periodo de tiempo: At time of drain removal (total estimated time: 1-4 weeks)
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Total drain output in cc will be reported as means with standard deviation if data is normally distributed and as medians with interquartile and absolute ranges if skewed. |
At time of drain removal (total estimated time: 1-4 weeks)
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Time of transfer procedure to drain removal as assessed in days
Periodo de tiempo: At time of procedure until time of drain removal (total estimated time 1-4 weeks)
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Drains will be removed when output is less than 30 cc over 24 hours. Time of transfer procedure to drain removal in days will be reported as means with standard deviation if data is normally distributed and as medians with interquartile and absolute ranges if skewed. |
At time of procedure until time of drain removal (total estimated time 1-4 weeks)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Justin Sacks, MD, MBA, FACS, Washington University School of Medicine
Publicaciones y enlaces útiles
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
Otros números de identificación del estudio
- 26-X358
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.
producto fabricado y exportado desde los EE. UU.
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