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Completed

NCT Number: NCT06015139

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.

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Key information

Conditions

Pressure Injury Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dachien Hospital

Miaoli, Gongjing Rd, No. 36, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

cotton roll-coated viscoelastic polymer pads

Device

relton-hall frame cotton roll-coated viscoelastic polymer pads

viscoelastic polymer pads

Device

relton-hall frame viscoelastic polymer pads

Primary outcomes

  1. Comparing two kinds of decompression materials, the incidence of Pressure Injury in lumbar patients after surgery

    Time frame: immediate post-operation, 30 minutes post-operation, 24 hours post-operation, and 48 hours post-operation

    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.

Sponsors and collaborators

Lead sponsor

Central Taiwan University of Science and Technology

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 29, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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