Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery

Central Taiwan University of Science and Technology

Status: Completed

Conditions: Pressure Injury

Treatments: Device: cotton roll-coated viscoelastic polymer pads; Device: viscoelastic polymer pads

Study type: Interventional

Funder types: Other

Identifiers

NCT06015139

游行盛

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

viscoelastic polymer pads

Active Comparator group

Description:

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

Treatment:

Device: viscoelastic polymer pads

cotton roll-coated viscoelastic polymer pads

Experimental group

Description:

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

Treatment:

Device: cotton roll-coated viscoelastic polymer pads