Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery

Pressure Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015139
• Other study ID #: Yu, Hsing-sheng
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: August 2023
• Source: Central Taiwan University of Science and Technology
• Contact: Hsing-sheng Yu
• Phone: +886913966976
• Email: youss35[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients receiving lumbar nerve decompression combined with internal fixation and bone fusion.

2. Use the positioning device Relton-Hall rack in prone position.

3. The operation time is more than 2.5 hours.

4. The surgical anesthesia is general anesthesia.

5. Routine surgery registered on the surgery schedule.

6. Before the operation, the skin was intact and there was no pressure injury.

Exclusion Criteria:

1. Emergency lumbar surgery patients.

2. Under the age of 18.

3. The operation time is less than 2.5 hours.

4. Preoperative skin incompleteness (obviously there is chest and iliac crest crush phenomenon).

5. Percutaneous minimally invasive disc herniation decompression (percutaneous endoscopic lumbar disc, PELD).

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Wounds and Injuries

Intervention

Device:
• cotton roll-coated viscoelastic polymer pads
relton-hall frame cotton roll-coated viscoelastic polymer pads
• viscoelastic polymer pads
relton-hall frame viscoelastic polymer pads

Locations

Country	Name	City	State
Taiwan	Dachien Hospital	Miaoli	Gongjing Rd

Sponsors (1)

Lead Sponsor	Collaborator
Central Taiwan University of Science and Technology

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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