Pressure InjuryNCT06015139
Preventing Pressure Injuries in Patients Undergoing Lumbar Spine Surgery
A study testing cotton roll-coated viscoelastic polymer pads and viscoelastic polymer pads in people with Pressure Injury, run by Central Taiwan University of Science and Technology at 1 site in Taiwan.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury
- What is being tested?
- cotton roll-coated viscoelastic polymer pads and viscoelastic polymer pads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to 29 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pressure Injury
- Being tested
- cotton roll-coated viscoelastic polymer pads, viscoelastic polymer pads
- Keywords
- pressure injury, positioning devices, prophylactic
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cotton roll-coated viscoelastic polymer padsDevice
relton-hall frame cotton roll-coated viscoelastic polymer pads
viscoelastic polymer padsDevice
relton-hall frame viscoelastic polymer pads
| Study group | Role | What they receive |
|---|---|---|
| viscoelastic polymer pads | Active comparator | while the control group used a Relton-Hall prone frame with a viscoelastic polymer pads Receives: Device: viscoelastic polymer pads |
| cotton roll-coated viscoelastic polymer pads | Experimental | The experimental group used a Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads Receives: Device: cotton roll-coated viscoelastic polymer pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing two kinds of decompression materials, the incidence of Pressure Injury in lumbar patients after surgery
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.
Measured: immediate post-operation, 30 minutes post-operation, 24 hours post-operation, and 48 hours post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2023
- Study completion29 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Taiwan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu, Hsing-Sheng, Central Taiwan University of Science and Technology
- Investigators
- Chin-Ying Dai, Study director, advising professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015139
- Sponsor's protocol ID
- 游行盛
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06015139
- Acronym / sponsor ID
- 游行盛
- Conditions
- Pressure Injury
- Keywords
- pressure injury, positioning devices, prophylactic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Central Taiwan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| viscoelastic polymer pads | Active comparator | Device: viscoelastic polymer padswhile the control group used a Relton-Hall prone frame with a viscoelastic polymer pads |
| cotton roll-coated viscoelastic polymer pads | Experimental | Device: cotton roll-coated viscoelastic polymer padsThe experimental group used a Relton-Hall prone frame with cotton roll-coated 3 cm viscoelastic polymer pads |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cotton roll-coated viscoelastic polymer padsrelton-hall frame cotton roll-coated viscoelastic polymer pads | Device | cotton roll-coated viscoelastic polymer pads |
| viscoelastic polymer padsrelton-hall frame viscoelastic polymer pads | Device | viscoelastic polymer pads |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Ying Dai study director
advising professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cotton roll-coated viscoelastic polymer pads and viscoelastic polymer pads in people with Pressure Injury, run by Central Taiwan University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.