Clinical trial NCT06015139: Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Injury
Keywords: pressure injury
positioning devices
prophylactic
Lead sponsor: Central Taiwan University of Science and Technology
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Comparing two kinds of decompression materials, the incidence of Pressure Injury in lumbar patients after surgery
timeFrame: immediate post-operation, 30 minutes post-operation, 24 hours post-operation, and 48 hours post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Miaoli
country: Taiwan
facility: Dachien Hospital
state: Gongjing Rd
Study officials:
affiliation: advising professor
name: Chin-Ying Dai
role: STUDY_DIRECTOR
References: