A Trial to Investigate the New Caulis Pro® Low Air Loss (LAL) System
- Conditions
- Health Adult SubjectsPressure Injury Prevention
- Registration Number
- NCT07213739
- Lead Sponsor
- Arjo AB
- Brief Summary
Investigation of biomechanical and physiological functions of laying on a new mattress in healthy volunteers.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Age 18-85
- Healthy male or female
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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. 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
- Secondary Outcome Measures
Name Time Method