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NCT Number: NCT07213739

A Trial to Investigate the New Caulis Pro® Low Air Loss (LAL) System

Investigation of biomechanical and physiological functions of laying on a new mattress in healthy volunteers.

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Key information

Conditions

Health Adult Subjects Pressure Injury Prevention

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This trial primary aims to investigate the biomechanical (interface pressure) and physiological (microvascular function) responses to prolonged lying postures during CLP when combined with pulsation therapy on a product not yet placed on the market (Caylis Pro® LAL System).

A secondary aim is to compare the frequency and amplitude of different pulsation modes with respect to the biomechanical and physiological responses at the participant-support surface interface.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-85
  • Healthy male or female

Exclusion criteria

  • Systemic skin disease
  • History of pressure ulcers in the sacrum or heels
  • Diabetes
  • Long term steroid use
  • Inability to maintain lying posture for prolonged periods

Treatment and study plan

CLP and pulsation

Device

As an alternative to manual repositioning, advanced air mattress systems have been introduced to periodically relieve support pressures.

A number of measurements have been used to examine the performance of support surfaces. As an example, interface pressure measurements between the individual and the support surface have been extensively used in both lab-based and clinical studies . We are now investigation the functions to reduce pressure in our new Caylis mattress

Primary outcomes

  1. This trial primary aims to investigate the biomechanical (interface pressure) and physiological (microvascular function) responses to prolonged lying postures during CLP when combined with pulsation therapy on a product not yet placed on the market.

    Time frame: Day 1 and 2

    • Comfort, support and firmness scores (using a 7 point verbal rating scale )
    • Interface pressure distribution (ForeSitePT, XSensor)
    • Transcutaneous gas levels
    • Microclimate measures between the participant and the support surface using temperature and humidity sensors (Sensiron SH75).
    • Internal Mattress air pressures

Study contacts

Contact information is provided by the study sponsor or research team.

Karin M Hannander, RN, Dir

CONTACT

[email protected]

+46721560709

Pete Worsley, Prof, Dr, PhD

CONTACT

[email protected]

+46721560709

Sponsors and collaborators

Lead sponsor

Arjo AB

Industry

Registry information

Official study title

A Laboratory Trial to Investigate the Biomechanical and Physiological Responses to Prolonged Lying Postures During CLP When Combined With Pulsation Therapy on Caylis Pro® Low Air Loss (LAL) System

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2025
Registry last updated
Oct 9, 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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