Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-06-29

Brief Summary

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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.

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Detailed Description

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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

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Pressure Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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viscoelastic polymer pads

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

Group Type ACTIVE_COMPARATOR

viscoelastic polymer pads

Intervention Type DEVICE

relton-hall frame viscoelastic polymer pads

cotton roll-coated viscoelastic polymer pads

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

Group Type EXPERIMENTAL

cotton roll-coated viscoelastic polymer pads

Intervention Type DEVICE

relton-hall frame cotton roll-coated viscoelastic polymer pads

Interventions

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cotton roll-coated viscoelastic polymer pads

relton-hall frame cotton roll-coated viscoelastic polymer pads

Intervention Type DEVICE

viscoelastic polymer pads

relton-hall frame viscoelastic polymer pads

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes