Surgical Recovery Support Pillow for Spine Surgeries
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult patients who have lumbar fusion surgery, who consent to participate
Disqualifiers
Pediatric patients 18 years old and under
Trial design
Design model
Single group
Treatments tested in this trial
Surgical Recovery Support Pillow
DeviceThe 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: ParticipantExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pillow use
Pillow use will be measured as a dichotomous measure of whether or not the pillow was used. Results will be summarized.
Time frame
One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgerySecondary outcomes
1
Pillow comfort and pain
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.
Time frame
One day after surgery, at discharge (approximately 1- 3 days after surgery) and 2 weeks after surgeryOther outcomes
1
Frequency of pillow usage
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.
Time frame
One day after surgery, on discharge day (approximately 1-3 days after surgery) and 2 weeks after surgerySponsors and contacts
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Source ClinicalTrials.gov