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Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery

Primary Purpose

Pressure Injury

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cotton roll-coated viscoelastic polymer pads
viscoelastic polymer pads
Sponsored by
Central Taiwan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Injury focused on measuring pressure injury, positioning devices, prophylactic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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: Emergency lumbar surgery patients. Under the age of 18. 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).

Sites / Locations

  • Dachien HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

viscoelastic polymer pads

cotton roll-coated viscoelastic polymer pads

Arm Description

while the control group used a Relton-Hall prone frame with a viscoelastic polymer pads

The experimental group used a Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 3, 2023
Last Updated
August 28, 2023
Sponsor
Central Taiwan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT06015139
Brief Title
Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Taiwan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury
Keywords
pressure injury, positioning devices, prophylactic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
viscoelastic polymer pads
Arm Type
Active Comparator
Arm Description
while the control group used a Relton-Hall prone frame with a viscoelastic polymer pads
Arm Title
cotton roll-coated viscoelastic polymer pads
Arm Type
Experimental
Arm Description
The experimental group used a Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads
Intervention Type
Device
Intervention Name(s)
cotton roll-coated viscoelastic polymer pads
Intervention Description
relton-hall frame cotton roll-coated viscoelastic polymer pads
Intervention Type
Device
Intervention Name(s)
viscoelastic polymer pads
Intervention Description
relton-hall frame viscoelastic polymer pads
Primary Outcome Measure Information:
Title
Comparing two kinds of decompression materials, the incidence of Pressure Injury in lumbar patients after surgery
Description
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.
Time Frame
immediate post-operation, 30 minutes post-operation, 24 hours post-operation, and 48 hours post-operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Emergency lumbar surgery patients. Under the age of 18. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsing-sheng Yu
Phone
+886913966976
Email
youss35@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin-Ying Dai
Organizational Affiliation
advising professor
Official's Role
Study Director
Facility Information:
Facility Name
Dachien Hospital
City
Miaoli
State/Province
Gongjing Rd
ZIP/Postal Code
No. 36
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsing Sheng Yu, nurse
Phone
886913966976
Email
youss35@yahoo.com.tw

12. IPD Sharing Statement

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Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery

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