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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| viscoelastic polymer pads | Active Comparator | while the control group used a Relton-Hall prone frame with a viscoelastic polymer pads |
|
| cotton roll-coated viscoelastic polymer pads | Experimental | The experimental group used a Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cotton roll-coated viscoelastic polymer pads | Device | relton-hall frame cotton roll-coated viscoelastic polymer pads |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing two kinds of decompression materials, the incidence of Pressure Injury in lumbar patients after surgery | 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. | immediate post-operation, 30 minutes post-operation, 24 hours post-operation, and 48 hours post-operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chin-Ying Dai | advising professor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dachien Hospital | Miaoli | Gongjing Rd | No. 36 | Taiwan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Proposal | Jul 7, 2023 | Aug 19, 2023 | Prot_000.pdf |
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form: Subject Consent | Jul 6, 2023 | Aug 22, 2023 | Prot_ICF_001.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| viscoelastic polymer pads | Device | relton-hall frame viscoelastic polymer pads |
|