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

NCT07213739 | Not Yet Recruiting

• 1 other identifier: CaylisPro-MACC-004-2025
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Health Adult Subjects; Pressure Injury Prevention

Keywords

caylis, Arjo

Outcome Measures

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.

  * 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

  Day 1 and 2

Study Arms (1)

1 study 2 separate session

OTHER

The healthy volunteers will be placed on a new mattress which has continuous low pressure (CLP and a pulsatio feature) and during that time period different measurements will be taken.

Device: CLP and pulsation

Interventions

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

1 study 2 separate session

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85
• Healthy male or female

You may not qualify if:

• 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

Sponsors & Collaborators

• Arjo AB: lead

Central Study Contacts

Pete Worsley, Prof, Dr, PhD

CONTACT

+46721560709; P.R.Worsley@soton.ac.uk

Karin M Hannander, RN, Dir

CONTACT

+46721560709; karin.hannander@arjo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, Director

Model Details: During the test each volunteer will adopt three distinct postures namely supine, lateral lying (pelvis titled to 30°) and cardiac high sitting (head of bed at 45°), while a series of measurements will be performed at the individual-support surface interface.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: October 9, 2025
• Study Start: September 30, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share