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OpenTrials
Completed

NCT Number: NCT06661954

Comparison of Sacral Interface Pressure in Healthy Volunteers on Two Dynamic Pressure-Prevention Support Surfaces

The purpose of the research study is to investigate the peak sacral interface pressures of two separate hospital bed systems in the supine and 30 degrees head-of-bed elevation position.

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Key information

Conditions

Healthy Volunteer Pressure Distribution Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • non-disabled
  • can walk & stand independently
  • can visit UAB SIM Lab once for 45 to 60 minutes

Exclusion criteria

-skin breakdown or compromising skin conditions

Treatment and study plan

Bed A - Head of Bed 0 degrees

Device

Low air loss mattress in supine position

Bed B - Head of Bed 0 degrees

Device

Standard hospital mattress in supine position

Bed A - Head of bed at 30 degrees

Device

Low air loss mattress with head of bed at 30 degrees

Bed B - head of bed at 30 degrees

Device

Standard hospital mattress with head of bed at 30 degrees

Primary outcomes

  1. Peak Sacral Pressure

    Time frame: minutes 1-3 and minutes 6-8

    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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Sacral Interface Pressure Mapping of Hospital Bed Systems

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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