An RCT on Support Surfaces for Pressure Ulcer Prevention

NCT03351049 | Completed Results FDA Device

• 1 other identifier: PRO16030036
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Injury; Pressure Ulcer

Keywords

Acute care, support surface

Outcome Measures

Primary Outcomes (1)

• Pressure Injury

  Number of participants who had a new pressure injury occur during study participation

  Through study completion, an average of 7 days

Study Arms (2)

Reactive, Low air loss support surface

EXPERIMENTAL

Participants in this arm will use a reactive support surface with a low air loss feature

Device: LAL

Reactive, non-low air loss

ACTIVE COMPARATOR

Participants in this arm will use a reactive support surface without a low air loss feature

Device: Non-LAL

Interventions

LAL DEVICE

Reactive support surface with a low air loss feature

Reactive, Low air loss support surface

Non-LAL DEVICE

Reactive support surface without a low air loss feature

Reactive, non-low air loss

Eligibility Criteria

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

You may qualify if:

• total Braden Score \<= 18
• Braden Moisture sub-scale score 1 or 2
• projected length of stay in hospital \>= 4 days
• absent of pressure injuries

Sponsors & Collaborators

• David Brienza: lead

Study Sites (1)

UPMC Presbyterian and Montefiore

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: David Brienza
• Organization: University of Pittsburgh

dbrienza@pitt.edu

412.624.6383

Study Officials

• David M Brienza, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 22, 2017
• Study Start: September 4, 2018
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: August 25, 2023
• Results First Posted: August 25, 2023

Record last verified: 2023-08

Locations

US (1)