Hospital Acquired Pressure InjuryNCT07171138
This Study Will Use Real-time Pressure Mapping Technology to Determine Which Positioning Strategies and Devices Exert the Least Amount of Pressure on Peri-operative Burn Patients
A study testing Positioning and positioning devices in people with Hospital Acquired Pressure Injury, run by Sunnybrook Health Sciences Centre.
Trial summary
Burn patients are especially vulnerable to developing hospital-acquired pressure sores. The goal of this study is to determine which positions and positioning devices exert the least amount of pressure on problem areas such as the heels, the tailbone, the elbow and the back of the head. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Acquired Pressure Injury
- What is being tested?
- Positioning and positioning devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (18 years of age or greater)
- burns of any size
- pre and post-operative patients
Who cannot join
- pediatric burn patients
- patients with pre-existing (pre-admission) pressure injuries
- patients unable to provide informed consent or decline consent
- patients with large burns that are not expected to survive past 72 hours
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pressure Injury Risk Related to Positioning and Positioning Devices in Burn Patients
Burn patients are especially vulnerable to developing hospital-acquired pressure sores. The goal of this study is to determine which positions and positioning devices exert the least amount of pressure on problem areas such as the heels, the tailbone, the elbow and the back of the head.
With the use of a pressure mapping device, it will allow the investigators to:
Read more
- Identify patients at the highest risk of developing pressure injuries related to positioning/devices.
- Use the findings to create positioning/device guidelines
By optimizing positioning strategies, the investigators aim to enhance patient comfort, prevent complications, and ultimately improve the overall quality of care for burn patients.
- Conditions
- Hospital Acquired Pressure Injury
- Being tested
- Positioning and positioning devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positioning and positioning devicesDevice
Also called X-sensor pressure mapping mat for determining positions of least amount of pressure
Different positioning strategies and positional devices. Measurement of skin interface pressure at key anatomical pressure points (occiput, elbows, sacrum, heels) under different patient positioning strategies and positional devices.
The positions that produce the least amount of pressure are identified and will be implemented and compared with pre-intervention hospital acquired pressure injuries (HAPI)
| Study group | Role | What they receive |
|---|---|---|
| HAPI incidence post-implementation of optimal positioning | Active comparator | Compare HAPI incidence post-implementation of positioning that produced the least pressure with retrospective pre-intervention HAPI incidence Receives: Device: Positioning and positioning devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pressure according to pressure mapping system/device (x-sensor)
Using a pressure mapping device, determine which positions and positioning devices create the most/least amount of pressure at known pressure points (occiput, elbows, sacrum, and heels).
Measured: 1 year
Secondary outcomes (1)
Compare HAPI incidence post-implementation of optimal positioning
Compare HAPI incidence post-implementation of positioning that produced the least pressure with retrospective pre-intervention HAPI incidence.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study startMay 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital Acquired 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
- Not applicable
- Intervention model
- Sequential
- Model description
- Pre/post study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171138
- Sponsor's protocol ID
- 6758
- Status last verified
- Oct 2025
- First submitted
- 26 Aug 2025
- Last updated
- 5 May 2026
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure Injury Risk Related to Positioning and Positioning Devices in Burn Patients
- ClinicalTrials.gov ID
- NCT07171138
- Acronym / sponsor ID
- 6758
- Conditions
- Hospital Acquired Pressure Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Sep 2025 (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.
Burn patients are especially vulnerable to developing hospital-acquired pressure sores. The goal of this study is to determine which positions and positioning devices exert the least amount of pressure on problem areas such as the heels, the tailbone, the elbow and the back of the head.
With the use of a pressure mapping device, it will allow the investigators to:
- Identify patients at the highest risk of developing pressure injuries related to positioning/devices.
- Use the findings to create positioning/device guidelines
By optimizing positioning strategies, the investigators aim to enhance patient comfort, prevent complications, and ultimately improve the overall quality of care for burn patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre/post study
| Arm | Type | Receives |
|---|---|---|
| HAPI incidence post-implementation of optimal positioning | Active comparator | Device: Positioning and positioning devicesCompare HAPI incidence post-implementation of positioning that produced the least pressure with retrospective pre-intervention HAPI incidence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients (18 years of age or greater)
- burns of any size
- pre and post-operative patients
Key exclusion criteria (4 listed)
- pediatric burn patients
- patients with pre-existing (pre-admission) pressure injuries
- patients unable to provide informed consent or decline consent
- patients with large burns that are not expected to survive past 72 hours
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 |
|---|---|---|
| Positioning and positioning devicesAlso: X-sensor pressure mapping mat for determining positions of least amount of pressureDifferent positioning strategies and positional devices. Measurement of skin interface pressure at key anatomical pressure points (occiput, elbows, sacrum, heels) under different patient positioning strategies and positional devices. The positions that produce the least amount of pressure are identified and will be implemented and compared with pre-intervention hospital acquired pressure injuries (HAPI) | Device | HAPI incidence post-implementation of optimal positioning |
Primary outcome
Measurement of pressure according to pressure mapping system/device (x-sensor)
Time frame: 1 year
Using a pressure mapping device, determine which positions and positioning devices create the most/least amount of pressure at known pressure points (occiput, elbows, sacrum, and heels).
1 secondary outcome
Compare HAPI incidence post-implementation of optimal positioning
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Pressure Ulcers (Hospital-acquired Pressure Injuries)
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Duke Virtual IntEgrated Workflow
Falls Injury, Readmission Rates
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Impact of Nurses' Behavior Change and Evidence-Based Practice Implementation on Quality Indicators in Intensive Care Units in Low- and Middle-Income Countries
Ventilator-Associated Pneumonia (VAP), Central Line-Associated Bloodstream Infection
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Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia
Hip Fractures (ICD-10 72.01-72.2)
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Development of a Nursing Care Bundle to Prevent Pressure Injuries and Its Impact on Rates and Costs
Pressure Injury, Hospital Acquired Pressure Ulcer
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.
Questions about this trial
What is this clinical trial studying?
A study testing Positioning and positioning devices in people with Hospital Acquired Pressure Injury, run by Sunnybrook Health Sciences Centre.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benji Choo (4164806199 ext. 7007, benji.choo@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pressure according to pressure mapping system/device (x-sensor) (time frame: 1 year). 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 5 May 2026.