Trial Outcomes & Findings for Comparison of Sacral Interface Pressure in Healthy Volunteers on Two Dynamic Pressure-Prevention Support Surfaces (NCT NCT06661954)

NCT ID: NCT06661954

Last Updated: 2025-11-20

Results Overview

Peak sacral pressure is defined as the highest pressure within a 9-10 cm squared area under the coccyx. The area under coccyx was identified prior to each condition tested using the pressure mapping system. Presure was recorded continuously for 15 minutes. Because the mattresses tested were advertised as 'cycling' pressure, with the cycles set to 5 minutes, the average of minutes 1-3 and 6-8 were used for analysis. These periods represent different phases of the 'cycling' where sacral pressure would conceivably differ.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: minutes 1-3 and minutes 6-8
• Results posted on: 2025-11-20

Participant Flow

Convivence sample of healthy non-disabled adults were recruited from personal and professional contacts of the study team and word of mouth. Recruitment occurred from 6/11/2024 through 10/23/2024

The protocol did not include any events between enrollment and assignment. All enrolled participants completed the protocol

Participant milestones

Measure	Healthy Adult Volunteers One Arm. Repeated measures. All participants are assessed in each of the four bed-position configurations. Bed-position assessment sequence is randomized for each participant. Bed A - Low air loss mattress with head of bed at 0 degrees Bed B - Standard hospital mattress with head of bed at 0 degrees Bed A - Low air loss mattress with head of bed at 30 degrees Bed B - Standard hospital mattress with head of bed at 30 degrees
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Healthy Adult Volunteers n=18 Participants One Arm. Repeated measures. All participants are assessed in each of the four bed-position configurations. Bed-position assessment sequence is randomized for each participant. Bed A - Low air loss mattress with head of bed at 0 degrees Bed B - Standard hospital mattress with head of bed at 0 degrees Bed A - Low air loss mattress with head of bed at 30 degrees Bed B - Standard hospital mattress with head of bed at 30 degrees
Age, Continuous	31.6 years STANDARD_DEVIATION 6.6 • n=18 Participants
Sex: Female, Male Female	9 Participants n=18 Participants
Sex: Female, Male Male	9 Participants n=18 Participants
Region of Enrollment United States	18 participants n=18 Participants
Height (inches)	67.9 inches STANDARD_DEVIATION 4.5 • n=18 Participants
Weight (pounds)	171.9 pounds STANDARD_DEVIATION 32.3 • n=18 Participants
BMI (kg/m2)	26.1 kg/m2 STANDARD_DEVIATION 3.7 • n=18 Participants

PRIMARY outcome

Timeframe: minutes 1-3 and minutes 6-8

Population: 18 participants completed the data collection protocol. 16 participants were included in the analysis. 2 participants were excluded from all analyses after inspection of their data suggested the position of the coccyx had been misidentified.

Peak sacral pressure is defined as the highest pressure within a 9-10 cm squared area under the coccyx. The area under coccyx was identified prior to each condition tested using the pressure mapping system. Presure was recorded continuously for 15 minutes. Because the mattresses tested were advertised as 'cycling' pressure, with the cycles set to 5 minutes, the average of minutes 1-3 and 6-8 were used for analysis. These periods represent different phases of the 'cycling' where sacral pressure would conceivably differ.

Outcome measures

Measure	Healthy Adult Volunteers n=16 Participants One Arm. Repeated measures. All participants are assessed in each of the four bed-position configurations. Bed-position assessment sequence is randomized for each participant. Bed A - Low air loss mattress with head of bed at 0 degrees Bed B - Standard hospital mattress with head of bed at 0 degrees Bed A - Low air loss mattress with head of bed at 30 degrees Bed B - Standard hospital mattress with head of bed at 30 degrees
Peak Sacral Pressure Bed A, Head of Bed 0 degrees Minutes 6-8	17.1 mm hg Standard Deviation 4.9
Peak Sacral Pressure Bed B, Head of Bed 0 degrees Minutes 6-8	21.6 mm hg Standard Deviation 4.6
Peak Sacral Pressure Bed A, Head of Bed 30 degrees Minutes 1-3	17.3 mm hg Standard Deviation 6.0
Peak Sacral Pressure Bed A, Head of Bed 0 degrees Minutes 1-3	17.8 mm hg Standard Deviation 4.2
Peak Sacral Pressure Bed B, Head of Bed 0 degrees Minutes 1-3	21.0 mm hg Standard Deviation 4.5
Peak Sacral Pressure Bed B, Head of Bed 30 degrees Minutes 1-3	24.9 mm hg Standard Deviation 8.7
Peak Sacral Pressure Bed A, Head of Bed 30 degrees Minutes 6-8	16.9 mm hg Standard Deviation 5.2
Peak Sacral Pressure Bed B, Head of Bed 30 degrees Minutes 6-8	25.7 mm hg Standard Deviation 8.6

Adverse Events

Healthy Adult Volunteers

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

Rachel Cowan, PhD

University of Alabama at Birmingham

Phone: 205-934-5034

Email: recowan@uabmc.edu

Results disclosure agreements

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