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

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.

Study Overview

• Status: Completed
• Conditions: Pressure Injury
• Intervention / Treatment: Device: viscoelastic polymer pads; Device: cotton roll-coated 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Gongjing Rd
    • Miaoli, Gongjing Rd, Taiwan, No. 36
      • Dachien Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: viscoelastic polymer pads; while the control group used a Relton-Hall prone frame with a viscoelastic polymer pads	Device: viscoelastic polymer pads; relton-hall frame viscoelastic polymer pads
Experimental: cotton roll-coated viscoelastic polymer pads; The experimental group used a Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads	Device: cotton roll-coated viscoelastic polymer pads; relton-hall frame cotton roll-coated viscoelastic polymer pads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Central Taiwan University of Science and Technology
• Investigators: Study Director: Chin-Ying Dai, advising professor

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): June 29, 2024

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: prophylactic; pressure injury; positioning devices
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Wounds and Injuries; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: 游行盛

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No