Trial Outcomes & Findings for An RCT on Support Surfaces for Pressure Ulcer Prevention (NCT NCT03351049)

NCT ID: NCT03351049

Last Updated: 2023-08-25

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 457 participants
• Primary outcome timeframe: Through study completion, an average of 7 days
• Results posted on: 2023-08-25

Participant Flow

Participants were recruited based upon chart review at 1 academic medical center between September 2018 and April 2022.

Of 457 enrolled participants, 451 met inclusion criteria and were randomized.

Participant milestones

Measure	Reactive, Low Air Loss Support Surface Participants in this arm will use a reactive support surface with a low air loss feature LAL: Reactive support surface with a low air loss feature	Reactive, Non-low Air Loss Participants in this arm will use a reactive support surface without a low air loss feature Non-LAL: Reactive support surface without a low air loss feature
Overall Study STARTED	323	128
Overall Study COMPLETED	297	106
Overall Study NOT COMPLETED	26	22

Reasons for withdrawal

Measure	Reactive, Low Air Loss Support Surface Participants in this arm will use a reactive support surface with a low air loss feature LAL: Reactive support surface with a low air loss feature	Reactive, Non-low Air Loss Participants in this arm will use a reactive support surface without a low air loss feature Non-LAL: Reactive support surface without a low air loss feature
Overall Study Withdrawal	26	22

Baseline Characteristics

An RCT on Support Surfaces for Pressure Ulcer Prevention

Baseline characteristics by cohort

Measure	Reactive, Low Air Loss Support Surface n=323 Participants Participants in this arm will use a reactive support surface with a low air loss feature LAL: Reactive support surface with a low air loss feature	Reactive, Non-low Air Loss n=128 Participants Participants in this arm will use a reactive support surface without a low air loss feature Non-LAL: Reactive support surface without a low air loss feature	Total n=451 Participants Total of all reporting groups
Age, Continuous	67.2 years STANDARD_DEVIATION 13.8 • n=5 Participants	68.3 years STANDARD_DEVIATION 14.5 • n=7 Participants	67.6 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	157 Participants n=5 Participants	73 Participants n=7 Participants	230 Participants n=5 Participants
Sex: Female, Male Male	166 Participants n=5 Participants	55 Participants n=7 Participants	221 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	247 Participants n=5 Participants	96 Participants n=7 Participants	343 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	74 Participants n=5 Participants	32 Participants n=7 Participants	106 Participants n=5 Participants
Race/Ethnicity, Customized White	240 Participants n=5 Participants	95 Participants n=7 Participants	335 Participants n=5 Participants
Race/Ethnicity, Customized Black	46 Participants n=5 Participants	24 Participants n=7 Participants	70 Participants n=5 Participants
Race/Ethnicity, Customized Other	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Missing	30 Participants n=5 Participants	9 Participants n=7 Participants	39 Participants n=5 Participants
Body Mass Index	28 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants	29 kg/m^2 STANDARD_DEVIATION 7 • n=7 Participants	28 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants
Braden Score	13.8 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants	13.8 units on a scale STANDARD_DEVIATION 2.2 • n=7 Participants	13.8 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 7 days

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

Outcome measures

Measure	Reactive, Low Air Loss Support Surface n=323 Participants Participants in this arm will use a reactive support surface with a low air loss feature LAL: Reactive support surface with a low air loss feature	Reactive, Non-low Air Loss n=128 Participants Participants in this arm will use a reactive support surface without a low air loss feature Non-LAL: Reactive support surface without a low air loss feature
Pressure Injury	23 Participants	10 Participants

Adverse Events

Reactive, Low Air Loss Support Surface

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reactive, Non-low Air Loss

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Brienza

University of Pittsburgh

Phone: 412.624.6383

Email: dbrienza@pitt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place