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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Pamela C Zuckerman, PhD
- Telefonnummer: 13479201340
- E-post: pcabahugzu@montefiore.org
Studieorter
-
-
New York
-
The Bronx, New York, Förenta staterna, 10461
- Rekrytering
- Montefiore Medical Center
-
Kontakt:
- Ananth C Eleswarapu, MD
- Telefonnummer: 718-920-2060
- E-post: aeleswarap@montefiore.org
-
Kontakt:
- Pamela C Zuckerman, PhD
- Telefonnummer: 347-920-1340
- E-post: pcabahugzu@montefiore.org
-
Huvudutredare:
- Ananth Eleswarapu, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Adult patients who have lumbar fusion surgery, who consent to participate
Exclusion Criteria:
- Pediatric patients 18 years old and under
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Participant
Surgical Recovery Support Pillow
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pillow use
Tidsram: One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
|
Pillow use will be measured as a dichotomous measure of whether or not the pillow was used.
Results will be summarized.
|
One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pillow comfort and pain
Tidsram: One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgery
|
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.
|
One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgery
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Frequency of pillow usage
Tidsram: One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
|
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.
|
One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ananth Eleswarapu, MD, Montefiore Medical Center
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-17746
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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