An RCT on Support Surfaces for Pressure Ulcer Prevention
Public ClinicalTrials.gov record NCT03351049. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Pressure injuries are a serious health care problem and affect millions of people. Most pressure injuries are avoidable with the application of best practices and with the use of appropriate technology. Support surfaces are a crucial component of any comprehensive prevention strategy. Decades of research have produced moderate and low levels of evidence upon which to base clinical decisions concerning how and when to apply support surfaces for prevention. This knowledge has been periodically assessed and assembled into clinical practice guidelines. There is good evidence that the combined group of active and reactive support surfaces is effective in preventing pressure injuries and that high-specification reactive foam surfaces are effective in preventing pressure injuries. But there is insufficient evidence that low air loss surfaces are more or less effective than other types of surfaces. Yet, low air loss surfaces are used for more than 17% of patients in acute care at high risk of developing pressure injuries. The study is designed to determine if and when low air loss is effective in preventing pressure injuries, and what level of heat and moisture control performance is necessary for prevention effectiveness. The primary aim of the project is to compare the effectiveness of reactive support surfaces with low air loss to reactive support surfaces without low air loss in preventing pressure injuries for people with moisture risk factors in acute care. Support surfaces are currently marketed and identified by practitioners based on device features (e.g., low air loss, air fluidization, alternating pressure), categories (powered, non-powered, reactive, and active) and components (e.g., foam, gel, fluid). The critical performance characteristics of low air loss systems are moisture, humidity and temperature management. Preliminary work has revealed that these characteristics vary widely among different low air loss products. A secondary aim of the proposed study is to explore associations between support surface performance characteristics and pressure injury outcomes to identify which low air loss performance characteristics and what level of those performance characteristics are necessary for the technology to be effective. Successful completion of this project will fill a critical gap in evidence regarding the effectiveness of support surfaces with low air loss, and could influence a shift in the way support surfaces are characterized away from the current feature-based paradigm toward a more clinically relevant and generalizable performance-based paradigm.
Study identification
- NCT ID
- NCT03351049
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 457 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 3, 2018
- Primary completion
- Jul 11, 2022
- Completion
- Jul 11, 2022
- Last update posted
- Aug 24, 2023
2018 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UPMC Presbyterian and Montefiore | Pittsburgh | Pennsylvania | 15213 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03351049, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03351049 live on ClinicalTrials.gov.