Surgical Recovery Support Pillow for Spine Surgeries
The present study investigates the feasibility of a support pillow for use after spinal surgical procedures, and more particularly, to protect the midline region of the back following spinal surgery.
Existing cushioning pillows do not accommodate the anatomy of the human back nor the requirements of isolating a vertical spinal incision. For example, donut-style or ring-shaped pillows are designed for entirely different purposes, such as hemorrhoidal relief, and cannot provide the desired spinal relief. As a result, there is no suitable, dedicated support structure that allows a patient to rest on their back while eliminating pressure on the surgical site. Accordingly, there is a need for a device that permits postoperative spinal surgery patients to sit or lie in a supine or reclined position without the surgical incision contacting or being compressed by any supporting surface.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigators hypothesize that use of the back saver pillow as currently designed will be feasible and that patients will report subjective improvement in pain when applying the pillow. Our specific aims are two-fold, namely (1) Determine if patients are able to utilize the back saver pillow as currently designed and (2) Survey patients as to whether they feel the back saver pillow was beneficial for their recovery.
Our study design is as follows. Eligible patients will be asked pre-op whether they would like to be part of this study and asked for informed consent prior to surgery. A total of 10 patients will be recruited. Enrolled patients will be provided with the back saver pillow either while admitted, if inpatient, or at the time of discharge for same-day surgery patients. Patients will be asked to fill out a survey with questions related to how easy the pillow was to use and whether they found it to reduce their pain on the rating scale of 1-10, where 1 is no pain and 10 is most painful. There will be 3 survey timepoints post-surgery: (1) on the day following surgery, (2) right before discharge and (3) 2-weeks post-surgery. Surveys will assess patient feedback about ease of use, and pain, first without the pillow in the supine position and sitting up with the back against another surface, then with the pillow in the supine position and sitting up with the back against another surface.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pamela C Zuckerman, PhD
- Número de teléfono: 13479201340
- Correo electrónico: pcabahugzu@montefiore.org
Ubicaciones de estudio
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New York
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The Bronx, New York, Estados Unidos, 10461
- Reclutamiento
- Montefiore Medical Center
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Contacto:
- Ananth C Eleswarapu, MD
- Número de teléfono: 718-920-2060
- Correo electrónico: aeleswarap@montefiore.org
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Contacto:
- Pamela C Zuckerman, PhD
- Número de teléfono: 347-920-1340
- Correo electrónico: pcabahugzu@montefiore.org
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Investigador principal:
- Ananth Eleswarapu, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patients who have lumbar fusion surgery, who consent to participate
Exclusion Criteria:
- Pediatric patients 18 years old and under
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 |
|---|---|
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Experimental: Participant
Surgical Recovery Support Pillow
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The Surgical Recovery Support Pillow for Spine Surgeries is a pillow with an open space in the middle in the shape of the spine.
The space can accommodate the healing of the surgical site wound by minimizing friction between pillow and spinal wound which can lead to disruption of the sutures and infections.
In contrast, normal pillows do not have a central open space in the shape of the spine, and does not minimize the wound friction.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pillow use
Periodo de tiempo: One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
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Pillow use will be measured as a dichotomous measure of whether or not the pillow was used.
Results will be summarized.
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One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pillow comfort and pain
Periodo de tiempo: One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgery
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Pillow comfort and pain will be assessed as a single composite measure on a scale from 1 to 10, with 1 being very little pain and 10 being extremely painful, such that higher scores are indicative of increased pain.
Assessments will be made both without the back saver pillow - in both the supine position and sitting up with back against another surface, and with the back saver pillow - in both the supine position and sitting up with back against another surface.
Results for each combination of pillow set up will be summarized using descriptive statistics.
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One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgery
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Frequency of pillow usage
Periodo de tiempo: One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
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For participants who used the pillow, frequency of pillow usage since it was administered will be summarized using the following ordinal variables: (1) Never (2) Sometimes or (3) All the time.
Results will be summarized using descriptive statistics.
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One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ananth Eleswarapu, MD, Montefiore Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Ghobrial GM, Harrop JS, Sasso RC, Tannoury CA, Tannoury T, Smith ZA, Hsu WK, Arnold PM, Fehlings MG, Mroz TE, De Giacomo AF, Jobse BC, Rahman RK, Thompson SE, Riew KD. Anterior Cervical Infection: Presentation and Incidence of an Uncommon Postoperative Complication. Global Spine J. 2017 Apr;7(1 Suppl):12S-16S. doi: 10.1177/2192568216687546. Epub 2017 Apr 1.
- Chaichana KL, Bydon M, Santiago-Dieppa DR, Hwang L, McLoughlin G, Sciubba DM, Wolinsky JP, Bydon A, Gokaslan ZL, Witham T. Risk of infection following posterior instrumented lumbar fusion for degenerative spine disease in 817 consecutive cases. J Neurosurg Spine. 2014 Jan;20(1):45-52. doi: 10.3171/2013.10.SPINE1364. Epub 2013 Nov 8.
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
Otros números de identificación del estudio
- 2026-17746
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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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