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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Pamela C Zuckerman, PhD
- 電話番号：13479201340
- メール：pcabahugzu@montefiore.org
研究場所
-
-
New York
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The Bronx、New York、アメリカ、10461
- 募集
- Montefiore Medical Center
-
コンタクト：
- Ananth C Eleswarapu, MD
- 電話番号：718-920-2060
- メール：aeleswarap@montefiore.org
-
コンタクト：
- Pamela C Zuckerman, PhD
- 電話番号：347-920-1340
- メール：pcabahugzu@montefiore.org
-
主任研究者：
- Ananth Eleswarapu, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adult patients who have lumbar fusion surgery, who consent to participate
Exclusion Criteria:
- Pediatric patients 18 years old and under
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pillow use
時間枠：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.
|
One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pillow comfort and pain
時間枠：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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency of pillow usage
時間枠：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.
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One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgery
|
協力者と研究者
捜査官
- 主任研究者：Ananth Eleswarapu, MD、Montefiore Medical Center
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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