Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery

NCT06015139 | Completed

• 1 other identifier: 游行盛
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Injury

Keywords

pressure injury; positioning devices; prophylactic

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

viscoelastic polymer pads

ACTIVE COMPARATOR

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

Device: 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

Device: cotton roll-coated viscoelastic polymer pads

Interventions

cotton roll-coated viscoelastic polymer pads DEVICE

relton-hall frame cotton roll-coated viscoelastic polymer pads

cotton roll-coated viscoelastic polymer pads

viscoelastic polymer pads DEVICE

relton-hall frame viscoelastic polymer pads

viscoelastic polymer pads

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Central Taiwan University of Science and Technology: lead

Study Sites (1)

Dachien Hospital

Miaoli, Gongjing Rd, No. 36, Taiwan

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chin-Ying Dai

  advising professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: August 29, 2023
• Study Start: August 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 29, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

TW (1)