Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery (NCT06015139) | Clinical Trial Compass
CompletedNot Applicable
Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery
Taiwan50 participantsStarted 2023-08-01
Plain-language summary
Background：Pressure injuries (PI) are one of the common comorbidities in surgery, meaning PI that occurs immediately after surgery or within hours to 3 days after surgery. The incidence of PI in spine surgery is about 5% \~ 66%.
Purpose：Comparison of the difference in pressure injury rates positioning device cotton roll-coated viscoelastic polymer pads versus viscoelastic polymer pads for pressure injuries undergoing lumbar spine surgery Methods：This experimental study used a split-body design with random assignment to compare the pressure-reducing effects of different materials on a patient's body contact points with a positioning device. The experimental group used a Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads, while the control group used a Relton-Hall prone frame with a viscoelastic polymer pads.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients receiving lumbar nerve decompression combined with internal fixation and bone fusion.
. Use the positioning device Relton-Hall rack in prone position.
. The operation time is more than 2.5 hours.
. The surgical anesthesia is general anesthesia.
. Routine surgery registered on the surgery schedule.
. Before the operation, the skin was intact and there was no pressure injury.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparing two kinds of decompression materials, the incidence of Pressure Injury in lumbar patients after surgery