A Trial to Investigate the New Caulis Pro® Low Air Loss (LAL) System
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorArjo AB
About this trial
Investigation of biomechanical and physiological functions of laying on a new mattress in healthy volunteers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-85
Healthy male or female
Disqualifiers
Systemic skin disease
History of pressure ulcers in the sacrum or heels
Diabetes
Long term steroid use
Trial design
Design model
Single group
Treatments tested in this trial
CLP and pulsation
DeviceAs 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: 1 study 2 separate sessionOther 1 intervention
Trial outcomes
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
Time frame
Day 1 and 2Locations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: