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
Phase: NA
Conditions: Pressure Injury
Sponsor: Central Taiwan University of Science and Technology

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Research Background:Pressure injury (pressure injuries, PI) is one of the common 
complications in surgery, which means PI that occurs immediately after surgery or within hours to 3 
days after surgery. The incidence of PI in spinal surgery is about 5%~66%. 
Purpose:This study compares the differences in PI in patients undergoing lumbar spine surgery 
when the positioning device uses cotton roll-coated viscoelastic polymer pads and viscoelastic 
polymer pads. 
Research methods:In this study, the split-body design was adopted as an experimental study of 
random assignment, and the four parts of the patient's body that were in contact with the positioning 
device (left chest, left iliac crest and right chest, right iliac crest) were randomly assigned to In the 
experimental group or the control group, compare the decompression effect of different materials on 
the positioning device on the patient; the experimental group uses the positioning device ReltonHall 
prone frame 3 cm cotton roll-coated viscoelastic polymer pads,and the control group uses the 
positioning device ReltonHall prone frame viscoelastic polymer pads. The research object is lumbar 
surgery patients in the operating room of a hospital in the north. It is expected to enroll 50 people. The 
experimental group or the control group will be assigned by random number table.the measurement 
time is before operation, immediately after operation, 30 minutes after operation, 24 hours after 
operation, and 48 hours after operation. This study uses SPSS 25.0 Chinese version package software 
for data analysis, descriptive statistics use frequency, percentage, average value, standard deviation, 
etc., and inferential statistics use independent sample t test, chi-square test, generalized estimating 
equation, etc. to analyze data. 
 
Keywords: lumbar spine surgery, pressure injury, positioning device, preventive, split design

  
  
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Research background and motivation 

  
  
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research object 
Patients with lumbar spine surgery in the operating room of a hospital in the north are eligible 
for inclusion as follows: 
Patients who underwent lumbar nerve decompression combined with internal fixation and 
bone fusion. 
Take the prone position using the ReltonHall rack. 
The operation time is greater than 2.5 hours. 
The surgical anesthesia is general anesthesia. 
Routine surgery registered in the surgery schedule. 
Before the operation, the skin was intact and there was no pressure injury. 
Exclusion criteriaas follows: 
Patients undergoing emergency lumbar surgery. 
2. 
Are younger than 18 years old. 
3. 
The operation time is less than 2.5 hours. 
4. 
Preoperative skin incompleteness (obvious chest and iliac crest pressure phenomenon). 
5. Percutaneous minimally invasive disc herniation decompression (percutaneous endoscopic 
lumbar disc, PELD). 
Sample Size Estimation 
The author refers to the research results of Yang et al. (2020) to estimate the sample size, estimates 
with G-power 3.1 software, sets the significance level of α value to 0.05, and the test power is 
0.80, using the ratio of two groups (chi-square test) To test the sample size, the minimum 
sample size for this study was determined to be 93 people. According to the estimated number 
of samples and pre-test results in the above literature, it is planned to collect 93 people. After 
correcting the sample loss rate, 100 people will be recruited. Since this study adopts a split test 
(self-experimental group and control group), it is estimated that Enroll 50 people. 
research ethics 
To follow the principles of patient autonomy, non-injury and confidentiality, before the 
research is conducted, the purpose and process of the research must be explained to the research 
subjects or their families, and the patients can request to stop at any time during the research 
process without affecting the future medical rights and safety. Before the implementation of this 
study, it is expected to be submitted to the Human Research Ethics Committee of a medical center 
in central China for review; the data of the research subjects will only be used for academic 
research to protect the privacy of the research subjects.
 

  
  
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Research Design Patterns 
group 
Pretes
t 
intervention 
Posttest I 
immediatel
y 
Posttest II 
30 minutes 
Posttest III 
24 hours 
Posttest IV 
48 hours 
Experim
ental side 
O1 
X1 
O2 
O3 
O4 
O5 
control 
side 
O1 
x 
O2 
O3 
O4 
O5 
Note: 
O1: After general anesthesia, the subject was placed supine to measure the integrity of the skin. 
X1: Refers to the experimental side chest and iliac crest positioning device ReltonHall fat pad 
wrapped cotton roll 3 cm. 
X: Refers to the ReltonHall, the positioning device of the chest and iliac crest of the control group, 
which is the fat pad routine. 
O2: Immediately after the operation, I was measured after the pressure injury was graded on the 
experimental side and the control side. 
O3: 30 minutes after the operation, the experimental side and the control side were tested for 
pressure injury grade II. 
O4: 24 hours after the operation, the experimental side and the control side were tested for pressure 
injury grade III. 
O5: 48 hours after the operation, test the IV after the pressure injury grade was carried out on the 
experimental side and the control side. 
 
Positioning and intervention methods 
The patient enters the operating room, and the four support cushions on the frame have been 
disposed in advance according to the experimental side and the control side. After general 

  
  
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anesthesia, the surgical team uses standard positioning steps to measure the body length: from the 2 
cm mark point of the armpit to the iliac side. between the bony crests; and body width: between the 
two iliac crests, then adjust the patient's posture and the contact surface of the prone frame 
according to the markings on the ReltonHall prone frame support pads to ensure that the pressure 
points on the patient's body are consistent with the marked points; place the patient Lie prone on the 
ReltonHall prone frame. After the patient is in the prone position, the horizontal line between the 
scapula and the posterior iliac crest must be parallel to the ground. 
 
1.Experimental side intervention method 
Viscoelastic polymer pads (Viscoelastic Polymer Pads) (model 40700; Action, Hagerstown, 
MD) were used on the 4 support columns of the Relton-Hall prone frame of the positioning device. 
The dimensions were: 18 cm long, 15 cm wide, and 2 cm thick. The fat pad accessories are 
designed to cover the four support columns of the Relton-Hall prone frame. The fat pad of the chest 
and iliac crest on the same side on the Relton-Hall prone frame is covered with a cotton roll for 3 
cm. The skin is the experimental side. 
 
 
 
 
 
向受試者說明實驗流程、目的、方法後填寫同意書
病房資料收集(包括個人特質與手術特質紀錄單、Munro scale 風險評估單)-
前測
隨機分派
手術室等候區依患者順序
抽取隨機採樣盒內相同序號信封
手術室中依信封內容部位實施實驗組及控制組
實驗組
Relton-Hall俯臥架
單側胸部、髂骨嵴
棉捲包覆3公分脂肪墊
控制組
Relton-Hall俯臥架
單側胸部、髂骨嵴
脂肪墊
從俯臥位恢復到仰臥位對患者的皮膚與擺位裝置Relton‑Hall 俯臥架 
接觸部位，評估皮膚狀況與壓傷程度。 
後測I、II、III、IV 
資料分析 
術後立即 後測I 
術後立即 後測I 
術後30 分鐘 後測II 
術後30 分鐘 後測II 
術後24 小時 後測III 
術後24 小時 後測III 
術後48 小時 後測IV 
術後48 小時 後測IV 

  
  
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2.Control Side Intervention Method 
In addition to the experimental side, the fat pad of the chest and iliac crest on the other side of 
the Relton-Hall prone frame, and the patient's skin contact position is the control side. 
Pressure injury record form, this record form is based on the wound evaluation indicators 
jointly developed by the National Pressure Ulcer Advisory Committee (NPIAP, 2016) and the 
European Pressure Ulcer Advisory Panel (EPUAP), according to the established Designed 
according to pressure injury grading standards. 
 
According to this record sheet, the recorded pressureing conditions are divided into "pre-
operative assessment", "immediately post-operative assessment", "30-minute post-operative 
assessment", "24-hour post-operative assessment", and "48-hour post-operative assessment". 
Nursing staff in the ward and wards should evaluate and record the pressure points that may cause 
pressure injuries. Including the site of occurrence and the grade of pressure injury. In order to 
increase the accuracy of the evaluation, the classification and description of the pressure injury are 
provided at the bottom of each record sheet for reference. 
Statistical analysis methods for various data 
data item 
Statistical analysis method 
1. Basic information of subjects: 
1. Gender, age, suffering from chronic 
diseases, BMI, operation time, albumin, 
intraoperative body temperature, and 
intraoperative blood pressure. 
Described in terms of times, 
percentages, etc. 
Chi-square was used to test whether 
there was a significant difference 
between the experimental group and 
the control group. 
2. Age, days of pressureing. 
Described by means, standard 
deviations, etc. 
Independent sample t test was used to 
test whether there was a significant 
difference between the experimental 
group and the control group. 
2. The pressured parts of the two groups of 
subjects (one-sided chest, iliac crest), whether 
there is PI in the compressed parts of the two 
groups, the contact point of one-sided chest 
and iliac crest (experimental group), the other 
side of the chest, The contact point of the iliac 
crest is (control group) 
Independent sample t was used to test 
whether there were significant differences 
between the experimental group and the 
control group immediately after 
operation, 30min, 24hr, and 48hr. 

  
  
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3. To test whether there are significant 
differences due to time factors between the 
two groups of subjects under the 
decompression material immediately after the 
operation, 30min, 24hr, and 48hr. 
Test the experimental group and the 
control group by the generalized 
estimating equation 
In the control group, immediately after 
operation, 30min, 24hr, 
48hr results measure whether there is an 
iteraction effect. 
 
 
 

  
  
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For lumbar surgery patients undergoing spinal posterior surgery (spinal posterior surgery), the 
intraoperative positioning device (Relton-Hall prone frame) is used for decompression materials, 
and cotton rolls are used to cover the fat pad and fat pad material, which is effective in preventing 
lumbar surgery patients. The incidence of injury is expected to be substantially improved.

  
  
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Chinese part 
Wu Zuoguang, Zhong Wenzhen, Cheng Liling, Dai Hongda (2009). Discussion on the prevention of 
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Chen Dumei (1998). Discussion on the prevalence of pressure sores and its related factors in 
hospitalized patients. Rong Zong Nursing, 15(1), 42-49. 
Dai Shuyi, Qiu Yihao, Chen Wanru, Lin Jiarong, Tang Xiuyan, Lin Zijia (2022). Effect of combined 
care program on preventing intraoperative pressure injury in surgical patients. Geigy Nursing, 
22(1), 83–96. 
 
English part 
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Tang, Z., Li, N., & Xu, J. (2021). Construction of a risk prediction model for intraoperative pressure 
injuries: a prospective, observational study. Journal of PeriAnesthesia Nursing, 36(5), 473–
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