Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery

Sponsor
Central Taiwan University of Science and Technology (Other)
Overall Status
Recruiting
CT.gov ID
NCT06015139
Collaborator
(none)
50
1
2
8
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: cotton roll-coated viscoelastic polymer pads
  • Device: viscoelastic polymer pads
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official 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
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dachien Hospital Miaoli Gongjing Rd Taiwan No. 36

Sponsors and Collaborators

  • Central Taiwan University of Science and Technology

Investigators

  • Study Director: Chin-Ying Dai, advising professor

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Yu, Hsing-Sheng, Principal Investigator, Central Taiwan University of Science and Technology
ClinicalTrials.gov Identifier:
NCT06015139
Other Study ID Numbers:
  • Yu, Hsing-sheng
First Posted:
Aug 29, 2023
Last Update Posted:
Aug 29, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yu, Hsing-Sheng, Principal Investigator, Central Taiwan University of Science and Technology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2023