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

NCT07171138 | Not Yet Recruiting

• 1 other identifier: 6758
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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. With the use of a pressure mapping device, it will allow the investigators to:

1. 1.Identify patients at the highest risk of developing pressure injuries related to positioning/devices.
2. 2.Use the findings to create positioning/device guidelines

Conditions

Hospital Acquired Pressure Injury

Outcome Measures

Primary Outcomes (1)

• 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).

  1 year

Secondary Outcomes (1)

• Compare HAPI incidence post-implementation of optimal positioning

  1 year

Study Arms (1)

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

Device: Positioning and positioning devices

Interventions

Positioning and positioning devices DEVICE

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)

Also known as: X-sensor pressure mapping mat for determining positions of least amount of pressure

HAPI incidence post-implementation of optimal positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (18 years of age or greater)
• burns of any size
• pre and post-operative patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

MeSH Terms

Interventions

Patient Positioning

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Benji Choo

CONTACT

4164806199; benji.choo@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre/post study

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 12, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-10