NCT06015139

Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Central Taiwan University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pressure Injury

Interventions

Type	Name	Description
DEVICE	cotton roll-coated viscoelastic polymer pads	relton-hall frame cotton roll-coated viscoelastic polymer pads
DEVICE	viscoelastic polymer pads	relton-hall frame viscoelastic polymer pads

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-12-31
• Completion: 2024-06-29
• First posted: 2023-08-29
• Last updated: 2024-07-23

Locations

1 site across 1 country: Taiwan