Comparison of the Effectiveness of Positioning Device Cotton Roll-coated Viscoelastic Polymer Pads Versus Viscoelastic Polymer Pads for Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Comparing two kinds of decompression materials, the incidence of Pressure Injury in lumbar patients after surgery
研究概览
简要总结
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.
详细描述
The study focuses on patients undergoing lumbar surgery in a hospital in a certain area of northern Taiwan, with an intended recruitment of 50 participants randomized into experimental and control groups. The study will use the Pressure Injury grading system developed by the National Pressure Injury Advisory Panel to assess the severity of pressure injuries at pre-operation, immediate post-operation, 30 minutes post-operation, 24 hours post-operation, and 48 hours post-operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Emergency lumbar surgery patients.
- •Under the age of
- •The operation time is less than 2.5 hours.
- •Preoperative skin incompleteness (obviously there is chest and iliac crest crush phenomenon).
- •Percutaneous minimally invasive disc herniation decompression (percutaneous endoscopic lumbar disc, PELD).
结局指标
主要结局
Comparing two kinds of decompression materials, the incidence of Pressure Injury in lumbar patients after surgery
时间窗: immediate post-operation, 30 minutes post-operation, 24 hours post-operation, and 48 hours post-operation
The four parts of the patient's body in contact with the positioning device (left chest, left iliac crest and right chest, right iliac crest) were randomly divided into an experimental group or a control group, and the decompression effect of different materials on positioning the device on the patient's body was compared; the experiment The group used the positioning device Relton-Hall prone frame cotton roll to cover the 3 cm fat pad, and the control group used the Relton-Hall prone frame fat pad. The severity of PI in the experimental and control groups was assessed and measured according to the pressure injury grading developed by the National Pressure Injury Advisory Committee. After surgery, return the patient from the prone position to the supine position. Immediately after the operation, 24 hours and 48 hours after the operation, observe the occurrence of pressure injury in the experimental group and the control group.
次要结局
未报告次要终点
研究者
Yu, Hsing-Sheng
Principal Investigator
Central Taiwan University of Science and Technology